Harmonised Standards

Official Journal C 389
of the European Union
Volume 60
English edition Information and Notices 17 November 2017
Contents
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
2017/C 389/01 Commission communication in the framework of the implementation of Directive 2014/68/EU of the
European Parliament and of the Council on the harmonisation of the laws of the Member States relating
to the making available on the market of pressure equipment (Publication of titles and references of
harmonised standards under Union harmonisation legislation) (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2017/C 389/02 Commission communication in the framework of the implementation of Council Directive 90/385/EEC
on the approximation of the laws of the Member States relating to active implantable medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation) (1) . . . . . 22
2017/C 389/03 Commission communication in the framework of the implementation of the Council Directive 93/42/
EEC concerning medical devices (Publication of titles and references of harmonised standards under Union
harmonisation legislation) (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2017/C 389/04 Commission communication in the framework of the implementation of the Directive 98/79/EC of the
European Parliament and of the Council on in vitro diagnostic medical devices (Publication of titles and
references of harmonised standards under Union harmonisation legislation) (1) . . . . . . . . . . . . . . . . . . . . . 62
2017/C 389/05 Commission communication in the framework of the implementation of Directive 1999/5/EC of the
European Parliament and of the Council on radio equipment and telecommunications terminal
equipment and the mutual recognition of their conformity and Directive 2014/53/EU of the European
Parliament and of the Council on the harmonisation of the laws of the Member States relating to the
making available on the market of radio equipment and repealing Directive 1999/5/EC (Publication of
titles and references of harmonised standards under Union harmonisation legislation) (1) . . . . . . . . . . . . . . 68
EN (1) Text with EEA relevance.

17.11.2017 EN Official Journal of the European Union C 389/1
IV
(Notices)
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND

AGENCIES
EUROPEAN COMMISSION
Commission communication in the framework of the implementation of Directive 2014/68/EU of the

European Parliament and of the Council on the harmonisation of the laws of the Member States
relating to the making available on the market of pressure equipment
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/01)
The following list contains references to harmonised standards for pressure equipment and harmonised supporting
standards for materials used in manufacturing pressure equipment. In the case of a harmonised supporting standard for
materials, presumption of conformity to the essential safety requirements is limited to technical data of materials in the
standard and does not presume adequacy of the material to a specific item of equipment. Consequently the technical data
stated in the material standard shall be assessed against the design requirements of this specific item of equipment to verify
that the essential safety requirements of the Pressure Equipment Directive are satisfied.
Date of cessation of
presumption of
Reference and title of the standard Reference of superseded
ESO (1) First publication OJ conformity of superseded
(and reference document) standard
standard
Note 1
(1) (2) (3) (4) (5)
CEN EN 3-8:2006 12.8.2016

Portable fire extinguishers — Part 8: Additional
requirements to EN 3-7 for the construction,
resistance to pressure and mechanical tests for
extinguishers with a maximum allowable pres-
sure equal to or lower than 30 bar
EN 3-8:2006/AC:2007 12.8.2016
CEN EN 19:2016 12.8.2016

Industrial valves — Marking of metallic valves
CEN EN 267:2009+A1:2011 12.8.2016

Automatic forced draught burners for liquid fuels
C 389/2 EN Official Journal of the European Union 17.11.2017
(1) (2) (3) (4) (5)
CEN EN 334:2005+A1:2009 12.8.2016

Gas pressure regulators for inlet pressures up to
100 bar
CEN EN 378-2:2016 This is the first EN 378-2:2008 The date of this pub-
Refrigerating systems and heat pumps — Safety publication +A2:2012 lication
and environmental requirements — Part 2: Note 2.1
Design, construction, testing, marking and doc-
umentation
CEN EN 593:2009+A1:2011 12.8.2016

Industrial valves — Metallic butterfly valves
CEN EN 676:2003+A2:2008 12.8.2016

Automatic forced draught burners for gaseous
fuels
EN 676:2003+A2:2008/AC:2008 12.8.2016
CEN EN 764-4:2014 12.8.2016

Pressure equipment — Part 4: Establishment of
technical delivery conditions for metallic mater-
ials
CEN EN 764-5:2014 12.8.2016

Pressure equipment — Part 5: Inspection doc-
umentation of metallic materials and compliance
with the material specification
CEN EN 764-7:2002 12.8.2016

Pressure equipment — Part 7: Safety systems for
unfired pressure equipment
EN 764-7:2002/AC:2006 12.8.2016
CEN EN 1057:2006+A1:2010 12.8.2016

Copper and copper alloys — Seamless, round
copper tubes for water and gas in sanitary and
heating applications
CEN EN 1092-1:2007+A1:2013 12.8.2016

Flanges and their joints — Circular flanges for
pipes, valves, fittings and accessories, PN desig-
nated — Part 1: Steel flanges
CEN EN 1092-3:2003 12.8.2016

nated — Part 3: Copper alloy flanges
(1) (2) (3) (4) (5)
EN 1092-3:2003/AC:2007 12.8.2016
CEN EN 1092-4:2002 12.8.2016

nated — Part 4: Aluminium alloy flanges
CEN EN 1171:2015 12.8.2016

Industrial valves — Cast iron gate valves
CEN EN 1252-2:2001 12.8.2016

Cryogenic vessels — Materials — Part 2:
Toughness requirements for temperatures be-
tween - 80 oC and - 20 oC
CEN EN 1349:2009 12.8.2016

Industrial process control valves
CEN EN 1515-4:2009 12.8.2016

Flanges and their joints — Bolting — Part 4:
Selection of bolting for equipment subject to the
Pressure Equipment Directive 97/23/EC
CEN EN 1562:2012 12.8.2016

Founding — Malleable cast irons
CEN EN 1563:2011 12.8.2016

Founding — Spheroidal graphite cast irons
CEN EN 1564:2011 12.8.2016

Founding — Ausferritic spheroidal graphite cast
irons
CEN EN 1591-1:2013 12.8.2016

Flanges and their joints — Design rules for
gasketed circular flange connections — Part 1:
Calculation
CEN EN 1626:2008 12.8.2016

Cryogenic vessels — Valves for cryogenic service
CEN EN 1653:1997 12.8.2016

Copper and copper alloys — Plate, sheet and
circles for boilers, pressure vessels and hot water
storage units
EN 1653:1997/A1:2000 12.8.2016 Note 3

(1) (2) (3) (4) (5)
CEN EN 1759-3:2003 12.8.2016

pipes, valves, fittings and accessories, Class
designated — Part 3: Copper alloy flanges
EN 1759-3:2003/AC:2004 12.8.2016
CEN EN 1759-4:2003 12.8.2016

Flanges and their joint — Circular flanges for
pipes, valves, fittings and accessories, class
designated — Part 4: Aluminium alloy flanges
CEN EN 1797:2001 12.8.2016

Cryogenic vessels — Gas/material compatibility
CEN EN 1866-2:2014 12.8.2016

Mobile fire extinguishers — Part 2: Requirements
for the construction, pressure resistance and
mechanical tests for extinguishers, with a max-
imum allowable pressure equal to or lower than
30 bar, which comply with the requirements of
EN 1866-1
CEN EN 1866-3:2013 12.8.2016

Mobile fire extinguishers — Part 3: Requirements
for the assembly, construction and pressure
resistance of CO2 extinguishers which comply
with the requirements of EN 1866-1
CEN EN 1983:2013 12.8.2016

Industrial valves — Steel ball valves
CEN EN 1984:2010 12.8.2016

Industrial valves — Steel gate valves
CEN EN ISO 4126-1:2013 12.8.2016

Safety devices for protection against excessive
pressure — Part 1: Safety valves (ISO 4126-
1:2013)
CEN EN ISO 4126-3:2006 12.8.2016

pressure — Part 3: Safety valves and bursting disc
safety devices in combination (ISO 4126-3:2006)
CEN EN ISO 4126-4:2013 12.8.2016

pressure — Part 4: Pilot-operated safety valves
(ISO 4126-4:2013)
(1) (2) (3) (4) (5)
CEN EN ISO 4126-5:2013 12.8.2016

pressure — Part 5: Controlled safety pressure
relief systems (CSPRS) (ISO 4126-5:2013)
CEN EN ISO 4126-7:2013 12.8.2016

pressure — Part 7: Common data (ISO 4126-
7:2013)
CEN EN ISO 9606-2:2004 12.8.2016

Qualification test of welders — Fusion welding —
Part 2: Aluminium and aluminium alloys (ISO
9606-2:2004)
CEN EN ISO 9606-3:1999 12.8.2016

Approval testing of welders — Fusion welding —
Part 3: Copper and copper alloys (ISO 9606-
3:1999)
CEN EN ISO 9606-4:1999 12.8.2016

Part 4: Nickel and nickel alloys (ISO 9606-
4:1999)
CEN EN ISO 9606-5:2000 12.8.2016

Part 5: Titanium and titanium alloys, zirconium
and zirconium alloys (ISO 9606-5:2000)
CEN EN ISO 9712:2012 12.8.2016

Non-destructive testing — Qualification and
certification of NDT personnel (ISO 9712:2012)
CEN EN 10028-1:2007+A1:2009 12.8.2016

Flat products made of steels for pressure
purposes — Part 1: General requirements
EN 10028-1:2007+A1:2009/AC:2009 12.8.2016
CEN EN 10028-2:2009 12.8.2016

purposes — Part 2: Non-alloy and alloy steels
with specified elevated temperature properties
CEN EN 10028-3:2009 12.8.2016

purposes — Part 3: Weldable fine grain steels,
normalized
CEN EN 10028-4:2009 12.8.2016

purposes — Part 4: Nickel alloy steels with
specified low temperature properties
(1) (2) (3) (4) (5)
CEN EN 10028-5:2009 12.8.2016

thermomechanically rolled
CEN EN 10028-6:2009 12.8.2016

quenched and tempered
CEN EN 10028-7:2016 This is the first EN 10028-7:2007 The date of this pub-
Flat products made of steels for pressure publication Note 2.1 lication
purposes — Part 7: Stainless steels
CEN EN 10204:2004 12.8.2016

Metallic products — Types of inspection docu-
ments
CEN EN 10213:2007+A1:2016 12.8.2016

Steel castings for pressure purposes
CEN EN 10216-1:2013 12.8.2016

Seamless steel tubes for pressure purposes —
Technical delivery conditions — Part 1: Non-alloy
steel tubes with specified room temperature
properties
CEN EN 10216-2:2013 12.8.2016

and alloy steel tubes with specified elevated
temperature properties
CEN EN 10216-3:2013 12.8.2016

Technical delivery conditions — Part 3: Alloy fine
grain steel tubes
CEN EN 10216-4:2013 12.8.2016

and alloy steel tubes with specified low tempera-
ture properties
CEN EN 10216-5:2013 12.8.2016

Technical delivery conditions — Part 5: Stainless
steel tubes
CEN EN 10217-1:2002 12.8.2016

Welded steel tubes for pressure purposes —
steel tubes with specified room temperature
properties
(1) (2) (3) (4) (5)
EN 10217-1:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-2:2002 12.8.2016

Technical delivery conditions — Part 2: Electric
welded non-alloy and alloy steel tubes with
specified elevated temperature properties
EN 10217-2:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-3:2002 12.8.2016

Technical delivery conditions — Part 3: Alloy fine
grain steel tubes
EN 10217-3:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-4:2002 12.8.2016

Technical delivery conditions — Part 4: Electric
welded non-alloy steel tubes with specified low
temperature properties
EN 10217-4:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-5:2002 12.8.2016

Technical delivery conditions — Part 5: Sub-
merged arc welded non-alloy and alloy steel tubes
with specified elevated temperature properties
EN 10217-5:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-6:2002 12.8.2016

Technical delivery conditions — Part 6: Sub-
merged arc welded non-alloy steel tubes with
specified low temperature properties
EN 10217-6:2002/A1:2005 12.8.2016 Note 3
CEN EN 10217-7:2014 12.8.2016

Technical delivery conditions — Part 7: Stainless
steel tubes
CEN EN 10222-1:2017 This is the first EN 10222-1:1998 31.10.2017

Steel forgings for pressure purposes — Part 1: publication Note 2.1
General requirements for open die forgings
(1) (2) (3) (4) (5)

Ferritic and martensitic steels with specified
elevated temperatures properties

Nickel steels with specified low temperature
properties

Weldable fine grain steels with high proof
strength

Martensitic, austenitic and austenitic-ferritic
stainless steels
CEN EN 10253-2:2007 12.8.2016

Butt-welding pipe fittings — Part 2: Non alloy
and ferritic alloy steels with specific inspection
requirements
CEN EN 10253-4:2008 12.8.2016

Butt-welding pipe fittings — Part 4: Wrought
austenitic and austenitic-ferritic (duplex) stainless
steels with specific inspection requirements
EN 10253-4:2008/AC:2009 12.8.2016
CEN EN 10269:2013 12.8.2016

Steels and nickel alloys for fasteners with
specified elevated and/or low temperature prop-
erties
CEN EN 10272:2016 This is the first EN 10272:2007 The date of this pub-
Stainless steel bars for pressure purposes publication Note 2.1 lication
Hot rolled weldable steel bars for pressure publication Note 2.1 lication
purposes with specified elevated temperature
properties
CEN EN 10305-4:2016 12.8.2016

Steel tubes for precision applications — Technical
delivery conditions — Part 4: Seamless cold
drawn tubes for hydraulic and pneumatic power
systems
CEN EN 10305-6:2016 12.8.2016

Steel tubes for precision applications — Technical
delivery conditions — Part 6: Welded cold drawn
tubes for hydraulic and pneumatic power systems
(1) (2) (3) (4) (5)
CEN EN ISO 10931:2005 12.8.2016

Plastics piping systems for industrial applica-
tions — Poly(vinylidene fluoride) (PVDF) —
Specifications for components and the system
(ISO 10931:2005)
EN ISO 10931:2005/A1:2015 12.8.2016 Note 3
Refrigerating systems and heat pumps — Liquid publication Note 2.1 lication
level indicating devices — Requirements, testing
and marking
CEN EN 12263:1998 12.8.2016

Refrigerating systems and heat pumps — Safety
switching devices for limiting the pressure —
Requirements and tests
CEN EN 12266-1:2012 12.8.2016

Industrial valves — Testing of metallic valves —
Part 1: Pressure tests, test procedures and
acceptance criteria — Mandatory requirements
CEN EN 12284:2003 12.8.2016

Refrigerating systems and heat pumps —
Valves — Requirements, testing and marking
CEN EN 12288:2010 12.8.2016

Industrial valves — Copper alloy gate valves
CEN EN 12392:2016 12.8.2016

Aluminium and aluminium alloys — Wrought
products and cast products — Special require-
ments for products intended for the production
of pressure equipment
CEN EN 12420:2014 12.8.2016

Copper and copper alloys — Forgings
CEN EN 12434:2000 12.8.2016

Cryogenic vessels — Cryogenic flexible hoses
EN 12434:2000/AC:2001 12.8.2016
CEN EN 12451:2012 12.8.2016

tubes for heat exchangers
CEN EN 12452:2012 12.8.2016

Copper and copper alloys — Rolled, finned,
seamless tubes for heat exchangers
(1) (2) (3) (4) (5)
CEN EN 12516-1:2014 12.8.2016

Industrial valves — Shell design strength —
Part 1: Tabulation method for steel valve shells
CEN EN 12516-2:2014 12.8.2016

Part 2: Calculation method for steel valve shells
CEN EN 12516-3:2002 12.8.2016

Valves — Shell design strength — Part 3:
Experimental method
EN 12516-3:2002/AC:2003 12.8.2016
CEN EN 12516-4:2014 12.8.2016

Part 4: Calculation method for valve shells
manufactured in metallic materials other than
steel
CEN EN 12542:2010 12.8.2016

LPG equipment and accessories — Static welded
steel cylindrical tanks, serially produced for the
storage of Liquefied Petroleum Gas (LPG) having
a volume not greater than 13 m3 — Design and
manufacture
CEN EN 12735-1:2016 12.8.2016

tubes for air conditioning and refrigeration —
Part 1: Tubes for piping systems
CEN EN 12735-2:2016 12.8.2016

tubes for air conditioning and refrigeration —
Part 2: Tubes for equipment
CEN EN 12778:2002 12.8.2016

Cookware — Pressure cookers for domestic use
EN 12778:2002/AC:2003 12.8.2016
EN 12778:2002/A1:2005 12.8.2016 Note 3

(1) (2) (3) (4) (5)
CEN EN 12952-1:2015 12.8.2016

Water-tube boilers and auxiliary installations —
Part 1: General
CEN EN 12952-2:2011 12.8.2016

Part 2: Materials for pressure parts of boilers and
accessories
CEN EN 12952-3:2011 12.8.2016

Part 3: Design and calculation for pressure parts
of the boiler
CEN EN 12952-5:2011 12.8.2016

Part 5: Workmanship and construction of
pressure parts of the boiler
CEN EN 12952-6:2011 12.8.2016

Part 6: Inspection during construction; docu-
mentation and marking of pressure parts of the
boiler
CEN EN 12952-7:2012 12.8.2016

Part 7: Requirements for equipment for the boiler
CEN EN 12952-8:2002 12.8.2016

Part 8: Requirements for firing systems for liquid
and gaseous fuels for the boiler
CEN EN 12952-9:2002 12.8.2016

Part 9: Requirements for firing systems for
pulverized solid fuels for the boiler
CEN EN 12952-10:2002 12.8.2016

Part 10: Requirements for safeguards against
excessive pressure
CEN EN 12952-11:2007 12.8.2016

Part 11: Requirements for limiting devices of the
boiler and accessories
CEN EN 12952-14:2004 12.8.2016

Part 14: Requirements for flue gas DENOX-
systems using liquefied pressurized ammonia and
ammonia water solution
(1) (2) (3) (4) (5)
CEN EN 12952-16:2002 12.8.2016

Part 16: Requirements for grate and fluidized-bed
firing systems for solid fuels for the boiler
CEN EN 12952-18:2012 12.8.2016

Part 18: Operating instructions
CEN EN 12953-1:2012 12.8.2016

Shell boilers — Part 1: General
CEN EN 12953-2:2012 12.8.2016

Shell boilers — Part 2: Materials for pressure
parts of boilers and accessories
CEN EN 12953-3:2016 12.8.2016

Shell boilers — Part 3: Design and calculation for
pressure parts
CEN EN 12953-4:2002 12.8.2016

Shell boilers — Part 4: Workmanship and
construction of pressure parts of the boiler
CEN EN 12953-5:2002 12.8.2016

Shell boilers — Part 5: Inspection during
construction, documentation and marking of
pressure parts of the boiler
CEN EN 12953-6:2011 12.8.2016

Shell Boilers — Part 6: Requirements for
equipment for the boiler
CEN EN 12953-7:2002 12.8.2016

Shell boilers — Part 7: Requirements for firing
systems for liquid and gaseous fuels for the
boilers
CEN EN 12953-8:2001 12.8.2016

Shell boilers — Part 8: Requirements for safe-
guards against excessive pressure
EN 12953-8:2001/AC:2002 12.8.2016
CEN EN 12953-9:2007 12.8.2016

Shell boilers — Part 9: Requirements for limiting
devices of the boiler and accessories
(1) (2) (3) (4) (5)
CEN EN 12953-12:2003 12.8.2016

Shell boilers — Part 12: Requirements for grate
firing systems for solid fuels for the boiler
CEN EN 12953-13:2012 12.8.2016

Shell boilers — Part 13: Operating instructions
CEN EN 13121-1:2003 12.8.2016

GRP tanks and vessels for use above ground —
Part 1: Raw materials — Specification conditions
and acceptance conditions
CEN EN 13121-2:2003 12.8.2016

Part 2: Composite materials — Chemical resist-
ance
CEN EN 13121-3:2016 12.8.2016

Part 3: Design and workmanship
CEN EN 13134:2000 12.8.2016

Brazing — Procedure approval
CEN EN 13136:2013 12.8.2016

Refrigerating systems and heat pumps — Pres-
sure relief devices and their associated piping —
Methods for calculation
CEN EN 13175:2014 12.8.2016

LPG Equipment and accessories — Specification
and testing for Liquefied Petroleum Gas (LPG)
pressure vessel valves and fittings
CEN EN 13348:2016 12.8.2016

copper tubes for medical gases or vacuum
CEN EN 13371:2001 12.8.2016

Cryogenic vessels — Couplings for cryogenic
service
CEN EN 13397:2001 12.8.2016

Industrial valves — Diaphragm valves made of
metallic materials
CEN EN 13445-1:2014 12.8.2016

Unfired pressure vessels — Part 1: General
(1) (2) (3) (4) (5)
EN 13445-1:2014/A1:2014 12.8.2016 Note 3
CEN EN 13445-2:2014 12.8.2016

Unfired pressure vessels — Part 2: Materials
EN 13445-2:2014/A1:2016 This is the first Note 3 The date of this pub-

publication lication
CEN EN 13445-3:2014 12.8.2016

Unfired pressure vessels — Part 3: Design
EN 13445-3:2014/A1:2015 12.8.2016 Note 3
EN 13445-3:2014/A2:2016 This is the first Note 3 The date of this pub-

CEN EN 13445-4:2014 12.8.2016

Unfired pressure vessels — Part 4: Fabrication
CEN EN 13445-5:2014 12.8.2016 The date of this pub-

Unfired pressure vessels — Part 5: Inspection and lication
testing
CEN EN 13445-6:2014 12.8.2016

Unfired pressure vessels — Part 6: Requirements
for the design and fabrication of pressure vessels
and pressure parts constructed from spheroidal
graphite cast iron
CEN EN 13445-8:2014 12.8.2016

Unfired pressure vessels — Part 8: Additional
requirements for pressure vessels of aluminium
and aluminium alloys
EN 13445-8:2014/A1:2014 12.8.2016 Note 3
CEN EN 13458-1:2002 12.8.2016

Cryogenic vessels — Static vacuum insulated
vessels — Part 1: Fundamental requirements
CEN EN 13458-2:2002 12.8.2016

vessels — Part 2: Design, fabrication, inspection
and testing
EN 13458-2:2002/AC:2006 12.8.2016
(1) (2) (3) (4) (5)

Metallic industrial piping — Part 1: General publication Note 2.1

Metallic industrial piping — Part 2: Materials publication Note 2.1

Metallic industrial piping — Part 3: Design and publication Note 2.1
calculation
CEN EN 13480-4:2012 12.8.2016

Metallic industrial piping — Part 4: Fabrication
and installation
EN 13480-4:2012/A1:2013 12.8.2016 Note 3
EN 13480-4:2012/A2:2015 12.8.2016 Note 3

Metallic industrial piping — Part 5: Inspection publication Note 2.1
and testing

Metallic industrial piping — Part 6: Additional publication Note 2.1
requirements for buried piping

Metallic industrial piping — Part 8: Additional publication Note 2.1
requirements for aluminium and aluminium alloy
piping
CEN EN 13547:2013 12.8.2016

Industrial valves — Copper alloy ball valves
CEN EN ISO 13585:2012 12.8.2016

Brazing — Qualification test of brazers and
brazing operators (ISO 13585:2012)
CEN EN 13648-1:2008 12.8.2016

Cryogenic vessels — Safety devices for protection
against excessive pressure — Part 1: Safety valves
for cryogenic service
CEN EN 13648-2:2002 12.8.2016

Cryogenic vessels — Safety devices for protection
against excessive pressure — Part 2: Bursting disc
safety devices for cryogenic service
(1) (2) (3) (4) (5)
CEN EN 13709:2010 12.8.2016

Industrial valves — Steel globe and globe stop
and check valves
CEN EN 13789:2010 12.8.2016

Industrial valves — Cast iron globe valves
CEN EN 13831:2007 12.8.2016

Closed expansion vessels with built in diaphragm
for installation in water
CEN EN 13835:2012 12.8.2016

Founding — Austenitic cast irons
CEN EN 13923:2005 12.8.2016

Filament-wound FRP pressure vessels — Mater-
ials, design, manufacturing and testing
CEN EN 14129:2014 12.8.2016

LPG Equipment and accessories — Pressure relief
valves for LPG pressure vessels
CEN EN 14197-1:2003 12.8.2016

Cryogenic vessels — Static non-vacuum insulated
vessels — Part 1: Fundamental requirements
CEN EN 14197-2:2003 12.8.2016

vessels — Part 2: Design, fabrication, inspection
and testing
EN 14197-2:2003/A1:2006 12.8.2016 Note 3
EN 14197-2:2003/AC:2006 12.8.2016
CEN EN 14197-3:2004 12.8.2016

vessels — Part 3: Operational requirements
EN 14197-3:2004/A1:2005 12.8.2016 Note 3
EN 14197-3:2004/AC:2004 12.8.2016
CEN EN 14222:2003 12.8.2016

Stainless steel shell boilers
(1) (2) (3) (4) (5)
CEN EN 14276-1:2006+A1:2011 12.8.2016

Pressure equipment for refrigerating systems and
heat pumps — Part 1: Vessels — General
requirements
CEN EN 14276-2:2007+A1:2011 12.8.2016

Pressure equipment for refrigerating systems and
heat pumps — Part 2: Piping — General
requirements
CEN EN 14359:2006+A1:2010 12.8.2016

Gas-loaded accumulators for fluid power applica-
tions
CEN EN 14382:2005+A1:2009 12.8.2016

Safety devices for gas pressure regulating stations
and installations — Gas safety shut-off devices for
inlet pressures up to 100 bar
EN 14382:2005+A1:2009/AC:2009 12.8.2016
CEN EN 14394:2005+A1:2008 12.8.2016

Heating boilers — Heating boilers with forced
draught burners — Nominal heat output not
exceeding 10 MW and maximum operating
temperature of 110 oC
CEN EN 14570:2014 12.8.2016

LPG equipment and accessories — Equipping of
overground and underground LPG vessels
CEN EN 14585-1:2006 12.8.2016

Corrugated metal hose assemblies for pressure
applications — Part 1: Requirements
CEN EN 14917:2009+A1:2012 12.8.2016

Metal bellows expansion joints for pressure
applications
CEN EN 15001-1:2009 12.8.2016

Gas Infrastructure — Gas installation pipework
with an operating pressure greater than 0,5 bar
for industrial installations and greater than 5 bar
for industrial and non-industrial installations —
Part 1: Detailed functional requirements for
design, materials, construction, inspection and
testing
(1) (2) (3) (4) (5)
CEN EN ISO 15493:2003 12.8.2016

Plastics piping systems for industrial applica-
tions — Acrylonitrile-butadiene-styrene (ABS),
unplasticized poly(vinyl chloride) (PVC-U) and
chlorinated poly(vinyl chloride) (PVC-C) — Spe-
cifications for components and the system —
Metric series (ISO 15493:2003)
EN ISO 15493:2003/A1:2017 This is the first Note 3 The date of this pub-
CEN EN ISO 15613:2004 12.8.2016

Specification and qualification of welding proce-
dures for metallic materials — Qualification
based on pre-production welding test (ISO
15613:2004)
CEN EN ISO 15614-1:2004 12.8.2016

dures for metallic materials — Welding proced-
ure test — Part 1: Arc and gas welding of steels
and arc welding of nickel and nickel alloys (ISO
15614-1:2004)
EN ISO 15614-1:2004/A1:2008 12.8.2016 Note 3
EN ISO 15614-1:2004/A2:2012 12.8.2016 Note 3
CEN EN ISO 15614-2:2005 12.8.2016

ure test — Part 2: Arc welding of aluminium and
its alloys (ISO 15614-2:2005)
EN ISO 15614-2:2005/AC:2009 12.8.2016
CEN EN ISO 15614-4:2005 12.8.2016

ure test — Part 4: Finishing welding of
aluminium castings (ISO 15614-4:2005)
EN ISO 15614-4:2005/AC:2007 12.8.2016
CEN EN ISO 15614-5:2004 12.8.2016

ure test — Part 5: Arc welding of titanium,
zirconium and their alloys (ISO 15614-5:2004)
(1) (2) (3) (4) (5)
CEN EN ISO 15614-6:2006 12.8.2016

ure test — Part 6: Arc and gas welding of copper
and its alloys (ISO 15614-6:2006)
CEN EN ISO 15614-7:2007 12.8.2016

ure test — Part 7: Overlay welding (ISO 15614-
7:2007)
CEN EN ISO 15614-8:2016 12.8.2016

ure test — Part 8: Welding of tubes to tube-plate
joints (ISO 15614-8:2016)
CEN EN ISO 15614-11:2002 12.8.2016

ure test — Part 11: Electron and laser beam
welding (ISO 15614-11:2002)
CEN EN ISO 15620:2000 12.8.2016

Welding — Friction welding of metallic materials
(ISO 15620:2000)
CEN EN 15776:2011+A1:2015 12.8.2016

Unfired pressure vessels — Requirements for the
design and fabrication of pressure vessels and
pressure parts constructed from cast iron with an
elongation after fracture equal or less than 15 %
CEN EN ISO 16135:2006 12.8.2016

Industrial valves — Ball valves of thermoplastics
materials (ISO 16135:2006)
CEN EN ISO 16136:2006 12.8.2016

Industrial valves — Butterfly valves of thermo-
plastics materials (ISO 16136:2006)
CEN EN ISO 16137:2006 12.8.2016

Industrial valves — Check valves of thermo-
(1) (2) (3) (4) (5)
CEN EN ISO 16138:2006 12.8.2016

Industrial valves — Diaphragm valves of thermo-
CEN EN ISO 16139:2006 12.8.2016

Industrial valves — Gate valves of thermoplastics
materials (ISO 16139:2006)
CEN EN 16767:2016 12.8.2016

Industrial valves — Steel and cast iron check
valves
CEN EN ISO 21009-2:2015 12.8.2016

vessels — Part 2: Operational requirements (ISO
21009-2:2015)
CEN EN ISO 21013-3:2016 12.8.2016

Cryogenic vessels — Pressure-relief accessories
for cryogenic service — Part 3: Sizing and
capacity determination (ISO 21013-3:2016)
CEN EN ISO 21028-1:2016 This is the first EN 1252-1:1998 The date of this pub-
Cryogenic vessels — Toughness requirements for publication Note 2.1 lication
materials at cryogenic temperature — Part 1:
Temperatures below - 80 oC (ISO 21028-1:2016)
CEN EN ISO 21787:2006 12.8.2016

Industrial valves — Globe valves of thermoplas-
tics materials (ISO 21787:2006)
(1) ESO: European standardisation organisation:

— CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)
— CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu)
— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the
European standardisation organisation, but attention of users of these standards is drawn to the fact that in
certain exceptional cases this can be otherwise.
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the
superseded standard ceases to give presumption of conformity with the essential or other requirements of the
relevant Union legislation.
Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard
ceases to give presumption of conformity with the essential or other requirements of the relevant Union
legislation.
Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated, the (partially)
relevant Union legislation for those products or services that fall within the scope of the new standard.
Presumption of conformity with the essential or other requirements of the relevant Union legislation for products
or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the
scope of the new standard, is unaffected.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the
new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous
amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases
to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
NOTE:
— Any information concerning the availability of the standards can be obtained either from the European standardisation
organisations or from the national standardisation bodies the list of which is published in the Official Journal of the
European Union according to Article 27 of the Regulation (EU) No 1025/2012 (1).
— Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in
French and German). Subsequently, the titles of the standards are translated into all other required official languages of
the European Union by the national standardisation bodies. The European Commission is not responsible for the
correctness of the titles which have been presented for publication in the Official Journal.
— References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic
or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or
German) of a standard as adopted by a European standardisation organisation.
— Publication of the references in the Official Journal of the European Union does not imply that the standards are available
in all the official languages of the European Union.
— This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission
ensures the updating of this list.
— More information about harmonised standards and other European standards on the Internet at:
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm
(1) OJ C 338, 27.9.2014, p. 31.

Commission communication in the framework of the implementation of Council Directive 90/385/

EEC on the approximation of the laws of the Member States relating to active implantable medical
devices
(2017/C 389/02)
presumption of
standard
Note 1
(1) (2) (3) (4) (5)
CEN EN 556-1:2001 31.7.2002 EN 556:1994 + 30.4.2002

Sterilization of medical devices — Requirements A1:1998
for medical devices to be designated ‘STERILE’ — Note 2.1
Part 1: Requirements for terminally sterilized
medical devices
EN 556-1:2001/AC:2006 15.11.2006
CEN EN 556-2:2015 13.5.2016 EN 556-2:2003 30.6.2016

Sterilization of medical devices — Requirements Note 2.1
for medical devices to be designated ‘STERILE’ —
Part 2: Requirements for aseptically processed
medical devices
CEN EN 1041:2008 19.2.2009 EN 1041:1998 31.8.2011

Information supplied by the manufacturer of Note 2.1
medical devices
CEN EN ISO 10993-1:2009 2.12.2009 EN ISO 10993-1:2009 21.3.2010

Biological evaluation of medical devices — Part 1: Note 2.1
Evaluation and testing within a risk management
process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010 18.1.2011
CEN EN ISO 10993-3:2014 10.7.2015

Biological evaluation of medical devices — Part 3:
Tests for genotoxicity, carcinogenicity and repro-
ductive toxicity (ISO 10993-3:2014)
CEN EN ISO 10993-4:2009 2.12.2009 EN ISO 10993-4:2002 21.3.2010

Selection of tests for interactions with blood (ISO
10993-4:2002, including Amd 1:2006)
(1) (2) (3) (4) (5)
CEN EN ISO 10993-5:2009 2.12.2009 EN ISO 10993-5:1999 31.12.2009

Tests for in vitro cytotoxicity (ISO 10993-
5:2009)
CEN EN ISO 10993-6:2009 2.12.2009 EN ISO 10993-6:2007 21.3.2010

Tests for local effects after implantation (ISO
10993-6:2007)
CEN EN ISO 10993-7:2008 7.7.2010

Ethylene oxide sterilization residuals (ISO 10993-
7:2008)
EN ISO 10993-7:2008/AC:2009 7.7.2010
CEN EN ISO 10993-9:2009 2.12.2009 EN ISO 10993-9:2009 21.3.2010

Framework for identification and quantification
of potential degradation products (ISO 10993-
9:2009)
CEN EN ISO 10993-11:2009 2.12.2009 EN ISO 10993- 21.3.2010

Biological evaluation of medical devices — 11:2006
Part 11: Tests for systemic toxicity (ISO 10993- Note 2.1
11:2006)
CEN EN ISO 10993-12:2012 24.1.2013 EN ISO 10993- 31.1.2013

Part 12: Sample preparation and reference Note 2.1
materials (ISO 10993-12:2012)
CEN EN ISO 10993-13:2010 18.1.2011 EN ISO 10993- 31.12.2010

Part 13: Identification and quantification of Note 2.1
degradation products from polymeric medical
devices (ISO 10993-13:2010)
CEN EN ISO 10993-16:2010 7.7.2010 EN ISO 10993- 31.8.2010

Part 16: Toxicokinetic study design for degrada- Note 2.1
tion products and leachables (ISO 10993-
16:2010)
CEN EN ISO 10993-17:2009 2.12.2009 EN ISO 10993- 21.3.2010

Part 17: Establishment of allowable limits for Note 2.1
leachable substances (ISO 10993-17:2002)
CEN EN ISO 10993-18:2009 2.12.2009 EN ISO 10993- 21.3.2010

Part 18: Chemical characterization of materials Note 2.1
(ISO 10993-18:2005)
(1) (2) (3) (4) (5)
CEN EN ISO 11135-1:2007 9.8.2007 EN 550:1994 31.5.2010

Sterilization of health care products — Ethylene Note 2.1
oxide — Part 1: Requirements for development,
validation and routine control of a sterilization
process for medical devices (ISO 11135-1:2007)
CEN EN ISO 11137-1:2015 13.5.2016 EN ISO 11137-1:2006 30.6.2016

Sterilization of health care products — Radia- Note 2.1
tion — Part 1: Requirements for development,
process for medical devices (ISO 11137-1:2006,
including Amd 1:2013)
CEN EN ISO 11137-2:2015 13.5.2016 EN ISO 11137-2:2013 30.6.2016

tion — Part 2: Establishing the sterilization dose
(ISO 11137-2:2013)
CEN EN ISO 11138-2:2009 2.12.2009 EN ISO 11138-2:2006 21.3.2010

Sterilization of health care products — Biological Note 2.1
indicators — Part 2: Biological indicators for
ethylene oxide sterilization processes (ISO
11138-2:2006)
CEN EN ISO 11138-3:2009 2.12.2009 EN ISO 11138-3:2006 21.3.2010

moist heat sterilization processes (ISO 11138-
3:2006)
CEN EN ISO 11140-1:2009 2.12.2009 EN ISO 11140-1:2005 21.3.2010

Sterilization of health care products — Chemical Note 2.1
indicators — Part 1: General requirements (ISO
11140-1:2005)
CEN EN ISO 11607-1:2009 2.12.2009 EN ISO 11607-1:2006 21.3.2010

Packaging for terminally sterilized medical de- Note 2.1
vices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
(ISO 11607-1:2006)
CEN EN ISO 11737-1:2006 7.9.2006 EN 1174-1:1996 31.10.2006

Sterilization of medical devices — Microbiologi- EN 1174-2:1996
cal methods — Part 1: Determination of a EN 1174-3:1996
population of microorganisms on products (ISO Note 2.1
11737-1:2006)
EN ISO 11737-1:2006/AC:2009 2.12.2009
CEN EN ISO 11737-2:2009 7.7.2010

Sterilization of medical devices — Microbiologi-
cal methods — Part 2: Tests of sterility performed
in the definition, validation and maintenance of a
sterilization process (ISO 11737-2:2009)
(1) (2) (3) (4) (5)
CEN EN ISO 13408-1:2015 13.5.2016 EN ISO 13408-1:2011 30.6.2016

Aseptic processing of health care products — Note 2.1
Part 1: General requirements (ISO 13408-
1:2008, including Amd 1:2013)
CEN EN ISO 13408-2:2011 19.8.2011 EN 13824:2004 31.12.2011

Part 2: Filtration (ISO 13408-2:2003)
CEN EN ISO 13408-3:2011 19.8.2011 EN 13824:2004 31.12.2011

Part 3: Lyophilization (ISO 13408-3:2006)
CEN EN ISO 13408-4:2011 19.8.2011 EN 13824:2004 31.12.2011

Part 4: Clean-in-place technologies (ISO 13408-
4:2005)
CEN EN ISO 13408-5:2011 19.8.2011 EN 13824:2004 31.12.2011

Part 5: Sterilization in place (ISO 13408-5:2006)
CEN EN ISO 13408-6:2011 19.8.2011 EN 13824:2004 31.12.2011

Part 6: Isolator systems (ISO 13408-6:2005)
CEN EN ISO 13408-7:2015 13.5.2016

Aseptic processing of health care products —
Part 7: Alternative processes for medical devices
and combination products (ISO 13408-7:2012)
CEN EN ISO 13485:2016 This is the first EN ISO 13485:2012 31.3.2019

Medical devices — Quality management sys- publication Note 2.1
tems — Requirements for regulatory purposes
(ISO 13485:2016)
EN ISO 13485:2016/AC:2016 This is the first

publication
CEN EN ISO 14155:2011 27.4.2012 EN ISO 14155:2011 30.4.2012

Clinical investigation of medical devices for Note 2.1
human subjects — Good clinical practice (ISO
14155:2011)

publication
CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 21.3.2010

Sterilization of health care products — General Note 2.1
requirements for characterization of a sterilizing
agent and the development, validation and
routine control of a sterilization process for
medical devices (ISO 14937:2009)
(1) (2) (3) (4) (5)
CEN EN ISO 14971:2012 30.8.2012 EN ISO 14971:2009 30.8.2012

Medical devices — Application of risk manage- Note 2.1
ment to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
CEN EN ISO 15223-1:2016 This is the first EN 980:2008 31.12.2017

Medical devices — Symbols to be used with publication Note 2.1
medical device labels, labelling and information
to be supplied — Part 1: General requirements
(ISO 15223-1:2016, Corrected version 2016-12-
15)
CEN EN ISO 17665-1:2006 15.11.2006 EN 554:1994 31.8.2009

Sterilization of health care products — Moist Note 2.1
heat — Part 1: Requirements for the develop-
ment, validation and routine control of a
sterilization process for medical devices (ISO
17665-1:2006)
CEN EN 45502-1:1997 27.8.1998

Active implantable medical devices — Part 1:
General requirements for safety, marking and
information to be provided by the manufacturer
Cenelec EN 45502-2-1:2003 8.7.2004

Active implantable medical devices — Part 2-1:
Particular requirements for active implantable
medical devices intended to treat bradyarrhyth-
mia (cardiac pacemakers)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec EN 45502-2-2:2008 27.11.2008

Particular requirements for active implantable
medical devices intended to treat tachyarrhyth-
mia (includes implantable defibrillators)
EN 45502-2-2:2008/AC:2009 18.1.2011
Cenelec EN 45502-2-3:2010 18.1.2011

Particular requirements for cochlear and auditory
brainstem implant systems
(1) (2) (3) (4) (5)
Cenelec EN 60601-1:2006 27.11.2008 EN 60601-1:1990 1.6.2012

Medical electrical equipment — Part 1: General + A13:1996
requirements for basic safety and essential + A1:1993
performance + A2:1995
IEC 60601-1:2005 Note 2.1
EN 60601-1:2006/AC:2010 18.1.2011
EN 60601-1:2006/A1:2013 10.7.2015 Note 3 31.12.2017

IEC 60601-1:2005/A1:2012
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN
60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on
31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses
referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive
90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.
Cenelec EN 60601-1-6:2010 18.1.2011

Medical electrical equipment — Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-6:2010
Cenelec EN 62304:2006 27.11.2008

Medical device software — Software life-cycle
processes
IEC 62304:2006
EN 62304:2006/AC:2008 18.1.2011

— CEN: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)
— Cenelec: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25196871; fax +32 25196919 (http://www.
cenelec.eu)
— ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE; tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu)
legislation.
NOTE:
(1) OJ C 338, 27.9.2014, p. 31.

Commission communication in the framework of the implementation of the Council Directive 93/
42/EEC concerning medical devices
(2017/C 389/03)
presumption of
standard
Note 1
(1) (2) (3) (4) (5)
CEN EN 285:2006+A2:2009 2.12.2009 EN 285:2006+A1:2008 21.3.2010

Sterilization — Steam sterilizers — Large steri- Note 2.1
lizers
CEN EN 455-1:2000 30.9.2005 EN 455-1:1993 30.4.2001

Medical gloves for single use — Part 1: Require- Note 2.1
ments and testing for freedom from holes
CEN EN 455-2:2009+A2:2013 16.5.2014 EN 455-2:2009 31.10.2014

Medical gloves for single use — Part 2: Require- +A1:2011
ments and testing for physical properties Note 2.1
CEN EN 455-3:2006 9.8.2007 EN 455-3:1999 30.6.2007

Medical gloves for single use — Part 3: Require- Note 2.1
ments and testing for biological evaluation
CEN EN 455-4:2009 7.7.2010

Medical gloves for single use — Part 4: Require-
ments and testing for shelf life determination
CEN EN 556-1:2001 31.7.2002 EN 556:1994 + 30.4.2002

medical devices
EN 556-1:2001/AC:2006 15.11.2006
CEN EN 556-2:2015 13.5.2016 EN 556-2:2003 30.6.2016

medical devices
(1) (2) (3) (4) (5)
CEN EN 794-3:1998+A2:2009 7.7.2010 EN 794-3:1998 21.3.2010

Lung ventilators — Part 3: Particular require- Note 2.1
ments for emergency and transport ventilators
CEN EN 1041:2008 19.2.2009 EN 1041:1998 31.8.2011

Information supplied by the manufacturer of Note 2.1
medical devices
CEN EN 1060-3:1997+A2:2009 7.7.2010 EN 1060-3:1997 31.5.2010

Non-invasive sphygmomanometers — Part 3: Note 2.1
Supplementary requirements for electro-mechan-
ical blood pressure measuring systems
CEN EN 1060-4:2004 30.9.2005

Non-invasive sphygmomanometers — Part 4:
Test procedures to determine the overall system
accuracy of automated non-invasive sphygmo-
manometers
CEN EN ISO 1135-4:2011 27.4.2012 EN ISO 1135-4:2010 30.4.2012

Transfusion equipment for medical use — Part 4: Note 2.1
Transfusion sets for single use (ISO 1135-4:2010)
CEN EN 1282-2:2005+A1:2009 7.7.2010 EN 1282-2:2005 21.3.2010

Tracheostomy tubes — Part 2: Paediatric tubes Note 2.1
(ISO 5366-3:2001, modified)
CEN EN 1422:1997+A1:2009 2.12.2009 EN 1422:1997 21.3.2010

Sterilizers for medical purposes — Ethylene oxide Note 2.1
sterilizers — Requirements and test methods
CEN EN 1618:1997 9.5.1998

Catheters other than intravascular catheters —
Test methods for common properties
CEN EN 1639:2009 7.7.2010 EN 1639:2004 30.4.2010

Dentistry — Medical devices for dentistry — Note 2.1
Instruments
CEN EN 1640:2009 7.7.2010 EN 1640:2004 30.4.2010

Equipment
CEN EN 1641:2009 7.7.2010 EN 1641:2004 30.4.2010

Materials
CEN EN 1642:2011 27.4.2012 EN 1642:2009 30.4.2012

Dental implants
(1) (2) (3) (4) (5)
CEN EN 1707:1996 17.5.1997

Conical fittings with a 6 % (Luer) taper for
syringes, needles and certain other medical
equipment — Lock fittings
CEN EN 1782:1998+A1:2009 7.7.2010 EN 1782:1998 21.3.2010

Tracheal tubes and connectors Note 2.1
CEN EN 1789:2007+A1:2010 18.1.2011

Medical vehicles and their equipment — Road
ambulances
CEN EN 1820:2005+A1:2009 7.7.2010 EN 1820:2005 21.3.2010

Anaesthetic reservoir bags (ISO 5362:2000, Note 2.1
modified)
CEN EN 1865-1:2010+A1:2015 13.5.2016

Patient handling equipment used in road ambu-
lances — Part 1: General stretcher systems and
patient handling equipment
CEN EN 1865-2:2010+A1:2015 13.5.2016

Patient handling equipment used in road ambu-
lances — Part 2: Power assisted stretcher
CEN EN 1865-3:2012 30.8.2012 EN 1865:1999 31.12.2012

Patient handling equipment used in road ambu- Note 2.1
lances — Part 3: Heavy duty stretcher
CEN EN 1865-4:2012 30.8.2012 EN 1865:1999 31.10.2012

lances — Part 4: Foldable patient transfer chair
CEN EN 1865-5:2012 30.8.2012 EN 1865:1999 31.12.2012

lances — Part 5: Stretcher support
CEN EN 1985:1998 10.8.1999

Walking aids — General requirements and test
methods
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended
standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of
the amended directive are appropriately covered.
CEN EN ISO 3826-2:2008 19.2.2009

Plastics collapsible containers for human blood
and blood components — Part 2: Graphical
symbols for use on labels and instruction leaflets
(ISO 3826-2:2008)
CEN EN ISO 3826-3:2007 27.2.2008

and blood components — Part 3: Blood bag
systems with integrated features (ISO 3826-
3:2006)
(1) (2) (3) (4) (5)
CEN EN ISO 3826-4:2015 13.5.2016

and blood components — Part 4: Aphaeresis
blood bag systems with integrated features (ISO
3826-4:2015)
CEN EN ISO 4074:2002 31.7.2002 EN 600:1996 31.8.2005

Natural latex rubber condoms — Requirements Note 2.1
and test methods (ISO 4074:2002)
CEN EN ISO 4135:2001 31.7.2002 EN ISO 4135:1996 28.2.2002

Anaesthetic and respiratory equipment — Voca- Note 2.1
bulary (ISO 4135:2001)
CEN EN ISO 5359:2008 23.7.2008 EN 739:1998 30.6.2010

Low-pressure hose assemblies for use with Note 2.1
medical gases (ISO 5359:2008)
EN ISO 5359:2008/A1:2011 30.8.2012 Note 3 30.6.2012
CEN EN ISO 5360:2009 2.12.2009 EN ISO 5360:2007 21.3.2010

Anaesthetic vaporizers — Agent-specific filling Note 2.1
systems (ISO 5360:2006)
CEN EN ISO 5366-1:2009 2.12.2009 EN ISO 5366-1:2004 21.3.2010

Anaesthetic and respiratory equipment — Tra- Note 2.1
cheostomy tubes — Part 1: Tubes and connectors
for use in adults (ISO 5366-1:2000)
CEN EN ISO 5840:2009 2.12.2009 EN ISO 5840:2005 21.3.2010

Cardiovascular implants — Cardiac valve pros- Note 2.1
theses (ISO 5840:2005)
CEN EN ISO 7197:2009 2.12.2009 EN ISO 7197:2006 21.3.2010

Neurosurgical implants — Sterile, single-use Note 2.1
hydrocephalus shunts and components (ISO
7197:2006, including Cor 1:2007)
CEN EN ISO 7376:2009 2.12.2009 EN ISO 7376:2009 21.3.2010

Anaesthetic and respiratory equipment — Lar- Note 2.1
yngoscopes for tracheal intubation (ISO
7376:2009)
CEN EN ISO 7396-1:2007 9.8.2007 EN 737-3:1998 30.4.2009

Medical gas pipeline systems — Part 1: Pipeline Note 2.1
systems for compressed medical gases and
vacuum (ISO 7396-1:2007)
EN ISO 7396-1:2007/A1:2010 7.7.2010 Note 3 31.7.2010

(1) (2) (3) (4) (5)
EN ISO 7396-1:2007/A2:2010 7.7.2010 Note 3 31.8.2010
CEN EN ISO 7396-2:2007 9.8.2007 EN 737-2:1998 30.4.2009

Medical gas pipeline systems — Part 2: Anaes- Note 2.1
thetic gas scavenging disposal systems (ISO
7396-2:2007)
CEN EN ISO 7886-3:2009 7.7.2010 EN ISO 7886-3:2005 21.3.2010

Sterile hypodermic syringes for single use — Note 2.1
Part 3: Auto-disable syringes for fixed-dose
immunization (ISO 7886-3:2005)
CEN EN ISO 7886-4:2009 7.7.2010 EN ISO 7886-4:2006 21.3.2010

Sterile hypodermic syringes for single use — Note 2.1
Part 4: Syringes with reuse prevention feature
(ISO 7886-4:2006)
CEN EN ISO 8185:2009 2.12.2009 EN ISO 8185:2007 21.3.2010

Respiratory tract humidifiers for medical use — Note 2.1
Particular requirements for respiratory humidifi-
cation systems (ISO 8185:2007)
CEN EN ISO 8359:2009 2.12.2009 EN ISO 8359:1996 21.3.2010

Oxygen concentrators for medical use — Safety Note 2.1
requirements (ISO 8359:1996)
EN ISO 8359:2009/A1:2012 16.1.2015 Note 3 31.1.2013
CEN EN ISO 8835-2:2009 2.12.2009 EN ISO 8835-2:2007 21.3.2010

Inhalational anaesthesia systems — Part 2: Note 2.1
Anaesthetic breathing systems (ISO 8835-
2:2007)
CEN EN ISO 8835-3:2009 2.12.2009 EN ISO 8835-3:2007 21.3.2010

Transfer and receiving systems of active anaes-
thetic gas scavenging systems (ISO 8835-3:2007)
EN ISO 8835-3:2009/A1:2010 13.5.2011 Note 3 30.4.2011
CEN EN ISO 8835-4:2009 2.12.2009 EN ISO 8835-4:2004 21.3.2010

Anaesthetic vapour delivery devices (ISO 8835-
4:2004)
CEN EN ISO 8835-5:2009 2.12.2009 EN ISO 8835-5:2004 21.3.2010

Anaesthetic ventilators (ISO 8835-5:2004)
(1) (2) (3) (4) (5)
CEN EN ISO 9170-1:2008 19.2.2009 EN 737-1:1998 31.7.2010

Terminal units for medical gas pipeline systems — Note 2.1
Part 1: Terminal units for use with compressed
medical gases and vacuum (ISO 9170-1:2008)
CEN EN ISO 9170-2:2008 19.2.2009 EN 737-4:1998 31.7.2010

Terminal units for medical gas pipeline systems — Note 2.1
Part 2: Terminal units for anaesthetic gas
scavenging systems (ISO 9170-2:2008)
CEN EN ISO 9360-1:2009 2.12.2009 EN ISO 9360-1:2000 21.3.2010

Anaesthetic and respiratory equipment — Heat Note 2.1
and moisture exchangers (HMEs) for humidifying
respired gases in humans — Part 1: HMEs for use
with minimum tidal volumes of 250 ml (ISO
9360-1:2000)
CEN EN ISO 9360-2:2009 2.12.2009 EN ISO 9360-2:2002 21.3.2010

Anaesthetic and respiratory equipment — Heat Note 2.1
and moisture exchangers (HMEs) for humidifying
respired gases in humans — Part 2: HMEs for use
with tracheostomized patients having minimum
tidal volumes of 250 ml (ISO 9360-2:2001)
CEN EN ISO 9713:2009 2.12.2009 EN ISO 9713:2004 21.3.2010

Neurosurgical implants — Self-closing intracra- Note 2.1
nial aneurysm clips (ISO 9713:2002)
CEN EN ISO 10079-1:2009 2.12.2009 EN ISO 10079-1:1999 21.3.2010

Medical suction equipment — Part 1: Electrically Note 2.1
powered suction equipment — Safety require-
ments (ISO 10079-1:1999)
CEN EN ISO 10079-2:2009 2.12.2009 EN ISO 10079-2:1999 21.3.2010

Medical suction equipment — Part 2: Manually Note 2.1
powered suction equipment (ISO 10079-2:1999)
CEN EN ISO 10079-3:2009 2.12.2009 EN ISO 10079-3:1999 21.3.2010

Medical suction equipment — Part 3: Suction Note 2.1
equipment powered from a vacuum or pressure
source (ISO 10079-3:1999)

Prosthetics — Structural testing of lower-limb publication Note 2.1
prostheses — Requirements and test methods
(ISO 10328:2016)
(1) (2) (3) (4) (5)
CEN EN ISO 10524-1:2006 2.6.2006 EN 738-1:1997 31.10.2008

Pressure regulators for use with medical gases — Note 2.1
Part 1: Pressure regulators and pressure regula-
tors with flow-metering devices (ISO 10524-
1:2006)
CEN EN ISO 10524-2:2006 7.6.2009 EN 738-2:1998 31.10.2008

Part 2: Manifold and line pressure regulators (ISO
10524-2:2005)
CEN EN ISO 10524-3:2006 7.9.2006 EN 738-3:1998 31.10.2008

Part 3: Pressure regulators integrated with
cylinder valves (ISO 10524-3:2005)
CEN EN ISO 10524-4:2008 23.7.2008 EN 738-4:1998 30.6.2010

Part 4: Low-pressure regulators (ISO 10524-
4:2008)
CEN EN ISO 10535:2006 9.8.2007 EN ISO 10535:1998 30.6.2007

Hoists for the transfer of disabled persons — Note 2.1
Requirements and test methods (ISO
10535:2006)
CEN EN ISO 10555-1:2009 2.12.2009 EN ISO 10555-1:1996 21.3.2010

Sterile, single-use intravascular catheters — Part 1: Note 2.1
General requirements (ISO 10555-1:1995, in-
cluding Amd 1:1999 and Amd 2:2004)
CEN EN ISO 10651-2:2009 2.12.2009 EN ISO 10651-2:2004 21.3.2010

Lung ventilators for medical use — Particular Note 2.1
performance — Part 2: Home care ventilators
for ventilator-dependent patients (ISO 10651-
2:2004)
CEN EN ISO 10651-4:2009 2.12.2009 EN ISO 10651-4:2002 21.3.2010

Lung ventilators — Part 4: Particular require- Note 2.1
ments for operator-powered resuscitators (ISO
10651-4:2002)
CEN EN ISO 10651-6:2009 2.12.2009 EN ISO 10651-6:2004 21.3.2010

Lung ventilators for medical use — Particular Note 2.1
performance — Part 6: Home-care ventilatory
support devices (ISO 10651-6:2004)
(1) (2) (3) (4) (5)
CEN EN ISO 10993-1:2009 2.12.2009 EN ISO 10993-1:2009 21.3.2010

Evaluation and testing within a risk management
process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010 18.1.2011
CEN EN ISO 10993-3:2014 10.7.2015 EN ISO 10993-3:2009 The date of this pub-
Biological evaluation of medical devices — Part 3: Note 2.1 lication
Tests for genotoxicity, carcinogenicity and repro-
ductive toxicity (ISO 10993-3:2014)
CEN EN ISO 10993-4:2009 2.12.2009 EN ISO 10993-4:2002 21.3.2010

Selection of tests for interactions with blood (ISO
10993-4:2002, including Amd 1:2006)
CEN EN ISO 10993-5:2009 2.12.2009 EN ISO 10993-5:1999 31.12.2009

Tests for in vitro cytotoxicity (ISO 10993-
5:2009)
CEN EN ISO 10993-6:2009 2.12.2009 EN ISO 10993-6:2007 21.3.2010

Tests for local effects after implantation (ISO
10993-6:2007)
CEN EN ISO 10993-7:2008 19.2.2009

Ethylene oxide sterilization residuals (ISO 10993-
7:2008)
EN ISO 10993-7:2008/AC:2009 7.7.2010
CEN EN ISO 10993-9:2009 2.12.2009 EN ISO 10993-9:2009 21.3.2010

Framework for identification and quantification
of potential degradation products (ISO 10993-
9:2009)
CEN EN ISO 10993-11:2009 2.12.2009 EN ISO 10993- 21.3.2010

Part 11: Tests for systemic toxicity (ISO 10993- Note 2.1
11:2006)
CEN EN ISO 10993-12:2012 24.1.2013 EN ISO 10993- 31.1.2013

Part 12: Sample preparation and reference Note 2.1
materials (ISO 10993-12:2012)
(1) (2) (3) (4) (5)
CEN EN ISO 10993-13:2010 18.1.2011 EN ISO 10993- 31.12.2010

degradation products from polymeric medical
devices (ISO 10993-13:2010)
CEN EN ISO 10993-14:2009 2.12.2009 EN ISO 10993- 21.3.2010

degradation products from ceramics (ISO
10993-14:2001)
CEN EN ISO 10993-15:2009 2.12.2009 EN ISO 10993- 21.3.2010

degradation products from metals and alloys
(ISO 10993-15:2000)
CEN EN ISO 10993-16:2010 7.7.2010 EN ISO 10993- 31.8.2010

Part 16: Toxicokinetic study design for degrada- Note 2.1
tion products and leachables (ISO 10993-
16:2010)
CEN EN ISO 10993-17:2009 2.12.2009 EN ISO 10993- 21.3.2010

Part 17: Establishment of allowable limits for Note 2.1
leachable substances (ISO 10993-17:2002)
CEN EN ISO 10993-18:2009 2.12.2009 EN ISO 10993- 21.3.2010

Part 18: Chemical characterization of materials Note 2.1
(ISO 10993-18:2005)
CEN EN ISO 11135-1:2007 9.8.2007 EN 550:1994 31.5.2010

Sterilization of health care products — Ethylene Note 2.1
oxide — Part 1: Requirements for development,
process for medical devices (ISO 11135-1:2007)
CEN EN ISO 11137-1:2015 13.5.2016 EN ISO 11137-1:2006 30.6.2016

CEN EN ISO 11137-2:2015 13.5.2016 EN ISO 11137-2:2013 30.6.2016

(ISO 11137-2:2013)
(1) (2) (3) (4) (5)
CEN EN ISO 11138-2:2009 2.12.2009 EN ISO 11138-2:2006 21.3.2010

ethylene oxide sterilization processes (ISO
11138-2:2006)
CEN EN ISO 11138-3:2009 2.12.2009 EN ISO 11138-3:2006 21.3.2010

moist heat sterilization processes (ISO 11138-
3:2006)
CEN EN ISO 11140-1:2009 2.12.2009 EN ISO 11140-1:2005 21.3.2010

indicators — Part 1: General requirements (ISO
11140-1:2005)
CEN EN ISO 11140-3:2009 2.12.2009 EN ISO 11140-3:2007 21.3.2010

indicators — Part 3: Class 2 indicator systems for
use in the Bowie and Dick-type steam penetration
test (ISO 11140-3:2007, including Cor 1:2007)
CEN EN ISO 11197:2009 2.12.2009 EN ISO 11197:2004 21.3.2010

Medical supply units (ISO 11197:2004) Note 2.1
CEN EN ISO 11607-1:2009 2.12.2009 EN ISO 11607-1:2006 21.3.2010

Packaging for terminally sterilized medical de- Note 2.1
vices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
(ISO 11607-1:2006)
CEN EN ISO 11607-2:2006 7.9.2006

Packaging for terminally sterilized medical de-
vices — Part 2: Validation requirements for
forming, sealing and assembly processes (ISO
11607-2:2006)
CEN EN ISO 11737-1:2006 7.9.2006 EN 1174-1:1996 31.10.2006

Sterilization of medical devices — Microbiologi- EN 1174-2:1996
cal methods — Part 1: Determination of a EN 1174-3:1996
population of microorganisms on products (ISO Note 2.1
11737-1:2006)
EN ISO 11737-1:2006/AC:2009 2.12.2009
CEN EN ISO 11737-2:2009 7.7.2010

(1) (2) (3) (4) (5)
CEN EN ISO 11810-1:2009 2.12.2009

Lasers and laser-related equipment — Test
method and classification for the laser resistance
of surgical drapes and/or patient protective
covers — Part 1: Primary ignition and penetra-
tion (ISO 11810-1:2005)
CEN EN ISO 11810-2:2009 2.12.2009 EN ISO 11810-2:2007 21.3.2010

Lasers and laser-related equipment — Test Note 2.1
method and classification for the laser-resistance
of surgical drapes and/or patient-protective
covers — Part 2: Secondary ignition (ISO
11810-2:2007)
CEN EN ISO 11979-8:2009 2.12.2009 EN ISO 11979-8:2006 21.3.2010

Ophthalmic implants — Intraocular lenses — Note 2.1
Part 8: Fundamental requirements (ISO 11979-
8:2006)
CEN EN ISO 11990-1:2014 10.7.2015

Lasers and laser-related equipment — Determina-
tion of laser resistance of tracheal tubes — Part 1:
Tracheal tube shaft (ISO 11990-1:2011)
CEN EN ISO 11990-2:2014 10.7.2015

Lasers and laser-related equipment — Determina-
tion of laser resistance of tracheal tubes — Part 2:
Tracheal tube cuffs (ISO 11990-2:2010)
CEN EN 12006-2:1998+A1:2009 2.12.2009 EN 12006-2:1998 21.3.2010

Non active surgical implants — Particular Note 2.1
requirements for cardiac and vascular implants —
Part 2: Vascular prostheses including cardiac
valve conduits
CEN EN 12006-3:1998+A1:2009 2.12.2009 EN 12006-3:1998 21.3.2010

Non active surgical implants — Particular Note 2.1
requirements for cardiac and vascular implants —
Part 3: Endovascular devices
CEN EN 12183:2009 7.7.2010

Manual wheelchairs — Requirements and test
methods
CEN EN 12184:2009 7.7.2010

Electrically powered wheelchairs, scooters and
their chargers — Requirements and test methods
CEN EN 12342:1998+A1:2009 7.7.2010 EN 12342:1998 21.3.2010

Breathing tubes intended for use with anaesthetic Note 2.1
apparatus and ventilators
(1) (2) (3) (4) (5)
CEN EN 12470-1:2000+A1:2009 2.12.2009 EN 12470-1:2000 21.3.2010

Clinical thermometers — Part 1: Metallic liquid- Note 2.1
in-glass thermometers with maximum device
CEN EN 12470-2:2000+A1:2009 2.12.2009 EN 12470-2:2000 21.3.2010

Clinical thermometers — Part 2: Phase change Note 2.1
type (dot matrix) thermometers
CEN EN 12470-3:2000+A1:2009 2.12.2009 EN 12470-3:2000 21.3.2010

Clinical thermometers — Part 3: Performance of Note 2.1
compact electrical thermometers (non-predictive
and predictive) with maximum device
CEN EN 12470-4:2000+A1:2009 2.12.2009 EN 12470-4:2000 21.3.2010

Clinical thermometers — Part 4: Performance of Note 2.1
electrical thermometers for continuous measure-
ment
CEN EN 12470-5:2003 7.11.2003

Clinical thermometers — Part 5: Performance of
infra-red ear thermometers (with maximum
device)
CEN EN ISO 12870:2009 2.12.2009 EN ISO 12870:2004 21.3.2010

Ophthalmic optics — Spectacle frames — Re- Note 2.1
quirements and test methods (ISO 12870:2004)
CEN EN 13060:2014 10.7.2015 EN 13060:2004 The date of this pub-

Small steam sterilizers +A2:2010 lication
Note 2.1
CEN EN ISO 13408-1:2015 13.5.2016 EN ISO 13408-1:2011 30.6.2016

CEN EN ISO 13408-2:2011 19.8.2011 EN 13824:2004 31.12.2011

CEN EN ISO 13408-3:2011 19.8.2011 EN 13824:2004 31.12.2011

CEN EN ISO 13408-4:2011 19.8.2011 EN 13824:2004 31.12.2011

4:2005)
(1) (2) (3) (4) (5)
CEN EN ISO 13408-5:2011 19.8.2011 EN 13824:2004 31.12.2011

CEN EN ISO 13408-6:2011 19.8.2011 EN 13824:2004 31.12.2011

CEN EN ISO 13408-7:2015 13.5.2016


(ISO 13485:2016)

publication
CEN EN 13544-1:2007+A1:2009 7.7.2010 EN 13544-1:2007 21.3.2010

Respiratory therapy equipment — Part 1: Neb- Note 2.1
ulizing systems and their components
CEN EN 13544-2:2002+A1:2009 7.7.2010 EN 13544-2:2002 21.3.2010

Respiratory therapy equipment — Part 2: Tubing Note 2.1
and connectors
CEN EN 13544-3:2001+A1:2009 7.7.2010 EN 13544-3:2001 21.3.2010

Respiratory therapy equipment — Part 3: Air Note 2.1
entrainment devices
CEN EN 13624:2003 30.9.2005

Chemical disinfectants and antiseptics — Quan-
titative suspension test for the evaluation of
fungicidal activity of chemical disinfectants for
instruments used in the medical area — Test
method and requirements (phase 2, step 1)
CEN EN 13718-1:2008 19.2.2009 EN 13718-1:2002 28.2.2009

Medical vehicles and their equipment — Air Note 2.1
ambulances — Part 1: Requirements for medical
devices used in air ambulances
CEN EN 13718-2:2015 10.7.2015

Medical vehicles and their equipment — Air
ambulances — Part 2: Operational and technical
requirements for air ambulances
(1) (2) (3) (4) (5)
CEN EN 13726-1:2002 27.3.2003

Test methods for primary wound dressings —
Part 1: Aspects of absorbency
EN 13726-1:2002/AC:2003 2.12.2009
CEN EN 13726-2:2002 27.3.2003

Test methods for primary wound dressings —
Part 2: Moisture vapour transmission rate of
permeable film dressings
CEN EN 13727:2012 30.8.2012 EN 13727:2003 30.11.2012

Chemical disinfectants and antiseptics — Quan- Note 2.1
bactericidal activity in the medical area — Test
method and requirements (phase 2, step 1)
CEN EN 13867:2002+A1:2009 2.12.2009 EN 13867:2002 21.3.2010

Concentrates for haemodialysis and related Note 2.1
therapies
CEN EN 13976-1:2011 19.8.2011 EN 13976-1:2003 30.11.2011

Rescue systems — Transportation of incuba- Note 2.1
tors — Part 1: Interface conditions
CEN EN 13976-2:2011 19.8.2011 EN 13976-2:2003 30.11.2011

Rescue systems — Transportation of incuba- Note 2.1
tors — Part 2: System requirements
CEN EN 14079:2003 30.9.2005

Non-active medical devices — Performance
requirements and test methods for absorbent
cotton gauze and absorbent cotton and viscose
gauze
CEN EN 14139:2010 18.1.2011

Ophthalmic optics — Specifications for ready-to-
wear spectacles
CEN EN ISO 14155:2011 27.4.2012 EN ISO 14155:2011 30.4.2012

Clinical investigation of medical devices for Note 2.1
human subjects — Good clinical practice (ISO
14155:2011)

publication
CEN EN 14180:2003+A2:2009 7.7.2010 EN 14180:2003 21.3.2010

Sterilizers for medical purposes — Low tempera- +A1:2009
ture steam and formaldehyde sterilizers — Re- Note 2.1
quirements and testing
(1) (2) (3) (4) (5)
CEN EN 14348:2005 30.9.2005

mycobactericidal activity of chemical disinfec-
tants in the medical area including instrument
disinfectants — Test methods and requirements
(phase 2, step 1)
CEN EN ISO 14408:2009 2.12.2009 EN ISO 14408:2005 21.3.2010

Tracheal tubes designed for laser surgery — Note 2.1
Requirements for marking and accompanying
information (ISO 14408:2005)
CEN EN 14561:2006 15.11.2006

titative carrier test for the evaluation of bacter-
icidal activity for instruments used in the medical
area — Test method and requirements (phase 2,
step 2)
CEN EN 14562:2006 15.11.2006

titative carrier test for the evaluation of fungicidal
or yeasticidal activity for instruments used in the
medical area — Test method and requirements
(phase 2, step 2)
CEN EN 14563:2008 19.2.2009

titative carrier test for the evaluation of myco-
bactericidal or tuberculocidal activity of chemical
disinfectants used for instruments in the medical
area — Test method and requirements (phase 2,
step 2)
CEN EN ISO 14602:2011 27.4.2012 EN ISO 14602:2010 30.4.2012

Non-active surgical implants — Implants for Note 2.1
osteosynthesis — Particular requirements (ISO
14602:2010)
CEN EN ISO 14607:2009 2.12.2009 EN ISO 14607:2007 21.3.2010

Non-active surgical implants — Mammary im- Note 2.1
plants — Particular requirements (ISO
14607:2007)
CEN EN ISO 14630:2009 2.12.2009 EN ISO 14630:2008 21.3.2010

Non-active surgical implants — General require- Note 2.1
ments (ISO 14630:2008)
CEN EN 14683:2005 2.6.2006

Surgical masks — Requirements and test meth-
ods
(1) (2) (3) (4) (5)
CEN EN ISO 14889:2009 2.12.2009 EN ISO 14889:2003 21.3.2010

Ophthalmic optics — Spectacle lenses — Funda- Note 2.1
mental requirements for uncut finished lenses
(ISO 14889:2003)
CEN EN 14931:2006 15.11.2006

Pressure vessels for human occupancy (PVHO) —
Multi-place pressure chamber systems for hyper-
baric therapy — Performance, safety require-
ments and testing
CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 30.4.2010

CEN EN ISO 14971:2012 30.8.2012 EN ISO 14971:2009 30.8.2012

CEN EN ISO 15001:2011 27.4.2012 EN ISO 15001:2010 30.4.2012

Anaesthetic and respiratory equipment — Com- Note 2.1
patibility with oxygen (ISO 15001:2010)
CEN EN ISO 15002:2008 19.2.2009 EN 13220:1998 31.7.2010

Flow-metering devices for connection to terminal Note 2.1
units of medical gas pipeline systems (ISO
15002:2008)
CEN EN ISO 15004-1:2009 2.12.2009 EN ISO 15004-1:2006 21.3.2010

Ophthalmic instruments — Fundamental re- Note 2.1
quirements and test methods — Part 1: General
requirements applicable to all ophthalmic instru-
ments (ISO 15004-1:2006)

(ISO 15223-1:2016, Corrected version 2017-03)
CEN EN ISO 15747:2011 27.4.2012 EN ISO 15747:2010 30.4.2012

Plastic containers for intravenous injections (ISO Note 2.1
15747:2010)
CEN EN ISO 15798:2010 7.7.2010

Ophthalmic implants — Ophthalmic viscosurgi-
cal devices (ISO 15798:2010)
(1) (2) (3) (4) (5)
CEN EN ISO 15883-1:2009 2.12.2009 EN ISO 15883-1:2006 21.3.2010

Washer-disinfectors — Part 1: General require- Note 2.1
ments, terms and definitions and tests (ISO
15883-1:2006)
CEN EN ISO 15883-2:2009 2.12.2009 EN ISO 15883-2:2006 21.3.2010

Washer-disinfectors — Part 2: Requirements and Note 2.1
tests for washer-disinfectors employing thermal
disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils,
glassware, etc. (ISO 15883-2:2006)
CEN EN ISO 15883-3:2009 2.12.2009 EN ISO 15883-3:2006 21.3.2010

tests for washer-disinfectors employing thermal
disinfection for human waste containers (ISO
15883-3:2006)
CEN EN ISO 15883-4:2009 2.12.2009 EN ISO 15883-4:2008 21.3.2010

tests for washer-disinfectors employing chemical
disinfection for thermolabile endoscopes (ISO
15883-4:2008)
CEN EN 15986:2011 13.5.2011

Symbol for use in the labelling of medical
devices — Requirements for labelling of medical
devices containing phthalates
CEN EN ISO 16061:2009 7.7.2010 EN ISO 16061:2008 28.2.2010

Instrumentation for use in association with non- Note 2.1
active surgical implants — General requirements
(ISO 16061:2008, Corrected version 2009-03-
15)
CEN EN ISO 16201:2006 19.2.2009

Technical aids for disabled persons — Environ-
mental control systems for daily living (ISO
16201:2006)
CEN EN ISO 17510-1:2009 2.12.2009 EN ISO 17510-1:2007 21.3.2010

Sleep apnoea breathing therapy — Part 1: Sleep Note 2.1
apnoea breathing therapy equipment (ISO
17510-1:2007)
CEN EN ISO 17510-2:2009 2.12.2009 EN ISO 17510-2:2007 21.3.2010

Sleep apnoea breathing therapy — Part 2: Masks Note 2.1
and application accessories (ISO 17510-2:2007)
CEN EN ISO 17664:2004 30.9.2005

Sterilization of medical devices — Information to
be provided by the manufacturer for the proces-
sing of resterilizable medical devices (ISO
17664:2004)
(1) (2) (3) (4) (5)
CEN EN ISO 17665-1:2006 15.11.2006 EN 554:1994 31.8.2009

Sterilization of health care products — Moist Note 2.1
heat — Part 1: Requirements for the develop-
ment, validation and routine control of a
sterilization process for medical devices (ISO
17665-1:2006)
CEN EN ISO 18777:2009 2.12.2009 EN ISO 18777:2005 21.3.2010

Transportable liquid oxygen systems for medical Note 2.1
use — Particular requirements (ISO 18777:2005)
CEN EN ISO 18778:2009 2.12.2009 EN ISO 18778:2005 21.3.2010

Respiratory equipment — Infant monitors — Note 2.1
Particular requirements (ISO 18778:2005)
CEN EN ISO 18779:2005 30.9.2005

Medical devices for conserving oxygen and
oxygen mixtures — Particular requirements
(ISO 18779:2005)
CEN EN ISO 19054:2006 7.9.2006 EN 12218:1998 30.6.2008

Rail systems for supporting medical equipment Note 2.1
(ISO 19054:2005)
CEN EN 20594-1:1993 18.11.1995

Conical fittings with a 6 % (Luer) taper for
syringes, needles and certain other medical
equipment — Part 1: General requirements (ISO
594-1:1986)
EN 20594-1:1993/A1:1997 10.8.1999 Note 3 31.5.1998
EN 20594-1:1993/AC:1996 2.12.2009
CEN EN ISO 21534:2009 2.12.2009 EN ISO 21534:2007 21.3.2010

Non-active surgical implants — Joint replace- Note 2.1
ment implants — Particular requirements (ISO
21534:2007)
CEN EN ISO 21535:2009 2.12.2009 EN ISO 21535:2007 21.3.2010

ment implants — Specific requirements for hip-
joint replacement implants (ISO 21535:2007)
CEN EN ISO 21536:2009 2.12.2009 EN ISO 21536:2007 21.3.2010

ment implants — Specific requirements for knee-
joint replacement implants (ISO 21536:2007)
CEN EN ISO 21649:2009 7.7.2010 EN ISO 21649:2006 21.3.2010

Needle-free injectors for medical use — Require- Note 2.1
ments and test methods (ISO 21649:2006)
(1) (2) (3) (4) (5)
CEN EN ISO 21969:2009 7.7.2010 EN ISO 21969:2006 31.5.2010

High-pressure flexible connections for use with Note 2.1
medical gas systems (ISO 21969:2009)
CEN EN ISO 21987:2009 7.7.2010

Ophthalmic optics — Mounted spectacle lenses
(ISO 21987:2009)
CEN EN ISO 22442-1:2007 27.2.2008 EN 12442-1:2000 30.6.2008

Medical devices utilizing animal tissues and their Note 2.1
derivatives — Part 1: Application of risk
management (ISO 22442-1:2007)
CEN EN ISO 22442-2:2007 27.2.2008 EN 12442-2:2000 30.6.2008

derivatives — Part 2: Controls on sourcing,
collection and handling (ISO 22442-2:2007)
CEN EN ISO 22442-3:2007 27.2.2008 EN 12442-3:2000 30.6.2008

derivatives — Part 3: Validation of the elimina-
tion and/or inactivation of viruses and transmis-
sible spongiform encephalopathy (TSE) agents
(ISO 22442-3:2007)
CEN EN ISO 22523:2006 9.8.2007 EN 12523:1999 30.4.2007

External limb prostheses and external orthoses — Note 2.1
Requirements and test methods (ISO
22523:2006)

Prosthetics — Testing of ankle-foot devices and publication Note 2.1
foot units — Requirements and test methods
(ISO 22675:2016)
CEN EN ISO 23328-1:2008 19.2.2009 EN 13328-1:2001 30.9.2008

Breathing system filters for anaesthetic and Note 2.1
respiratory use — Part 1: Salt test method to
assess filtration performance (ISO 23328-
1:2003)
CEN EN ISO 23328-2:2009 2.12.2009 EN ISO 23328-2:2008 21.3.2010

Breathing system filters for anaesthetic and Note 2.1
respiratory use — Part 2: Non-filtration aspects
(ISO 23328-2:2002)
CEN EN ISO 23747:2009 2.12.2009 EN ISO 23747:2007 21.3.2010

Anaesthetic and respiratory equipment — Peak Note 2.1
expiratory flow meters for the assessment of
pulmonary function in spontaneously breathing
humans (ISO 23747:2007)
(1) (2) (3) (4) (5)
CEN EN ISO 25539-1:2009 2.12.2009 EN 12006-3:1998 21.3.2010

Cardiovascular implants — Endovascular de- +A1:2009
vices — Part 1: Endovascular prostheses (ISO EN ISO 25539-1:2008
25539-1:2003 including Amd 1:2005) Note 2.1
EN ISO 25539-1:2009/AC:2011 30.8.2012
CEN EN ISO 25539-2:2009 2.12.2009 EN 12006-3:1998 21.3.2010

Cardiovascular implants — Endovascular de- +A1:2009
vices — Part 2: Vascular stents (ISO 25539- EN ISO 25539-2:2008
2:2008) Note 2.1
EN ISO 25539-2:2009/AC:2011 30.8.2012
CEN EN ISO 26782:2009 7.7.2010

Anaesthetic and respiratory equipment — Spi-
rometers intended for the measurement of time
forced expired volumes in humans (ISO
26782:2009)
EN ISO 26782:2009/AC:2009 7.7.2010
CEN EN 27740:1992 18.11.1995

Instruments for surgery, scalpels with detachable
blades, fitting dimensions (ISO 7740:1985)
EN 27740:1992/A1:1997 10.8.1999 Note 3 31.5.1998
EN 27740:1992/AC:1996 2.12.2009
CEN EN ISO 81060-1:2012 30.8.2012 EN 1060-1:1995 31.5.2015

Non-invasive sphygmomanometers — Part 1: +A2:2009
Requirements and test methods for non-auto- EN 1060-2:1995
mated measurement type (ISO 81060-1:2007) +A1:2009
Note 2.1
Cenelec EN 60118-13:2005 19.1.2006 EN 60118-13:1997 1.2.2008

Electroacoustics — Hearing aids — Part 13: Note 2.1
Electromagnetic compatibility (EMC)
IEC 60118-13:2004
Cenelec EN 60522:1999 14.11.2001

Determination of the permanent filtration of X-
ray tube assemblies
IEC 60522:1999
Cenelec EN 60580:2000 13.12.2002

Medical electrical equipment — Dose area
product meters
IEC 60580:2000
(1) (2) (3) (4) (5)
Cenelec EN 60601-1:2006 27.11.2008 EN 60601-1:1990 1.6.2012

Medical electrical equipment — Part 1: General + A13:1996
requirements for basic safety and essential + A1:1993
performance + A2:1995
IEC 60601-1:2005 EN 60601-1-1:2001
EN 60601-1-4:1996
+ A1:1999
Note 2.1
EN 60601-1:2006/AC:2010 18.1.2011
EN 60601-1:2006/A1:2013 16.5.2014 Note 3 31.12.2017

IEC 60601-1:2005/A1:2012
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN
60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015.
As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in
Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC,
to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.
Cenelec EN 60601-1-1:2001 14.11.2001 EN 60601-1-1:1993 1.11.2003

Medical electrical equipment — Part 1-1: General + A1:1996
requirements for safety — Collateral standard: Note 2.1
Safety requirements for medical electrical systems
IEC 60601-1-1:2000
Cenelec EN 60601-1-2:2015 13.5.2016 EN 60601-1-2:2007 31.12.2018

Medical electrical equipment — Part 1-2: General Note 2.1
performance — Collateral Standard: Electromag-
netic disturbances — Requirements and tests
IEC 60601-1-2:2014
Cenelec EN 60601-1-3:2008 27.11.2008 EN 60601-1-3:1994 1.6.2012

performance — Collateral Standard: Radiation
protection in diagnostic X-ray equipment
IEC 60601-1-3:2008
EN 60601-1-3:2008/AC:2010 18.1.2011
EN 60601-1-3:2008/A11:2016 This is the first Note 3 1.11.2019

publication
(1) (2) (3) (4) (5)
Cenelec EN 60601-1-4:1996 8.11.1997

Medical electrical equipment — Part 1-4: General
requirements for safety — Collateral standard:
Programmable electrical medical systems
IEC 60601-1-4:1996
EN 60601-1-4:1996/A1:1999 8.11.1997 Note 3 1.12.2002

IEC 60601-1-4:1996/A1:1999
Cenelec EN 60601-1-6:2010 18.1.2011 EN 60601-1-6:2007 1.4.2013

performance — Collateral standard: Usability
IEC 60601-1-6:2010
Cenelec EN 60601-1-8:2007 27.11.2008 EN 60601-1-8:2004 1.6.2012

Medical electrical equipment — Part 1-8: General + A1:2006
requirements for basic safety and essential Note 2.1
performance — Collateral Standard: General
requirements, tests and guidance for alarm
systems in medical electrical equipment and
medical electrical systems
IEC 60601-1-8:2006
EN 60601-1-8:2007/AC:2010 18.1.2011

publication
Cenelec EN 60601-1-10:2008 27.11.2008

Medical electrical equipment — Part 1-10:
General requirements for basic safety and
essential performance — Collateral Standard:
Requirements for the development of physiologic
closed-loop controllers
IEC 60601-1-10:2007
Cenelec EN 60601-1-11:2010 18.1.2011

General requirements for basic safety and
essential performance — Collateral standard:
Requirements for medical electrical equipment
and medical electrical systems used in the home
healthcare environment
IEC 60601-1-11:2010
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-1:1998 14.11.2001

Medical electrical equipment — Part 2-1: Particu-
lar requirements for the safety of electron
accelerators in the range of 1 MeV to 50 MeV
IEC 60601-2-1:1998
EN 60601-2-1:1998/A1:2002 13.12.2002 Note 3 1.6.2005

IEC 60601-2-1:1998/A1:2002
Cenelec EN 60601-2-2:2009 7.7.2010 EN 60601-2-2:2007 1.4.2012

Medical electrical equipment — Part 2-2: Particu- Note 2.1
lar requirements for the basic safety and essential
performance of high frequency surgical equip-
ment and high frequency surgical accessories
IEC 60601-2-2:2009
Cenelec EN 60601-2-3:1993 18.11.1995

Medical electrical equipment — Part 2: Particular
requirements for the safety of short-wave therapy
equipment
IEC 60601-2-3:1991
EN 60601-2-3:1993/A1:1998 18.11.1995 Note 3 1.7.2001

IEC 60601-2-3:1991/A1:1998
Cenelec EN 60601-2-4:2003 15.10.2003

lar requirements for the safety of cardiac
defibrillators
IEC 60601-2-4:2002
Cenelec EN 60601-2-5:2000 13.12.2002

lar requirements for the safety of ultrasonic
physiotherapy equipment
IEC 60601-2-5:2000
Cenelec EN 60601-2-8:1997 14.11.2001

requirements for the safety of therapeutic X-ray
equipment operating in the range 10 kV to 1 MV
IEC 60601-2-8:1987
EN 60601-2-8:1997/A1:1997 14.11.2001 Note 3 1.7.1998

IEC 60601-2-8:1987/A1:1997
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-10:2000 13.12.2002

Particular requirements for the safety of nerve
and muscle stimulators
IEC 60601-2-10:1987
EN 60601-2-10:2000/A1:2001 13.12.2002 Note 3 1.11.2004

IEC 60601-2-10:1987/A1:2001
Cenelec EN 60601-2-11:1997 9.10.1999

Particular requirements for the safety of gamma
beam therapy equipment
IEC 60601-2-11:1997
EN 60601-2-11:1997/A1:2004 9.10.1999 Note 3 1.9.2007

IEC 60601-2-11:1997/A1:2004
Cenelec EN 60601-2-12:2006 22.12.2007

Particular requirements for the safety of lung
ventilators — Critical care ventilators
IEC 60601-2-12:2001
Cenelec EN 60601-2-13:2006 22.12.2007

Particular requirements for the safety and
essential performance of anaesthetic systems
IEC 60601-2-13:2003
EN 60601-2-13:2006/A1:2007 22.12.2007 Note 3 1.3.2010

IEC 60601-2-13:2003/A1:2006
Cenelec EN 60601-2-16:1998 9.10.1999

Particular requirements for the safety of haemo-
dialysis, haemodiafiltration and haemofiltration
equipment
IEC 60601-2-16:1998
EN 60601-2-16:1998/AC:1999 18.1.2011
Cenelec EN 60601-2-17:2004 8.11.2005 EN 60601-2-17:1996 1.3.2007

Medical electrical equipment — Part 2-17: + A1:1996
Particular requirements for the safety of auto- Note 2.1
matically-controlled brachytherapy afterloading
equipment
IEC 60601-2-17:2004
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-18:1996 9.10.1999

requirements for the safety of endoscopic equip-
ment
IEC 60601-2-18:1996
EN 60601-2-18:1996/A1:2000 9.10.1999 Note 3 1.8.2003

IEC 60601-2-18:1996/A1:2000
Cenelec EN 60601-2-19:2009 7.7.2010 EN 60601-2-19:1996 1.4.2012

Particular requirements for the basic safety and Note 2.1
essential performance of infant incubators
IEC 60601
IEC 60601-2-19:2009
Cenelec EN 60601-2-20:2009 18.1.2011 EN 60601-2-20:1996 1.9.2012

Medical electrical equipment — Part 2-20: Note 2.1
Particular requirements for the basic safety and
essential performance of infant transport incu-
bators
IEC 60601
IEC 60601-2-20:2009
Cenelec EN 60601-2-21:2009 7.7.2010 EN 60601-2-21:1994 1.4.2012

essential performance of infant radiant warmers
IEC 60601-2-21:2009
Cenelec EN 60601-2-22:1996 17.5.1997

requirements for the safety of diagnostic and
therapeutic laser equipment
IEC 60601-2-22:1995
Cenelec EN 60601-2-23:2000 14.11.2001 EN 60601-2-23:1997 1.1.2003

Particular requirements for the safety, including
essential performance, of transcutaneous partial
pressure monitoring equipment
IEC 60601-2-23:1999
Cenelec EN 60601-2-24:1998 9.10.1999

Particular requirements for the safety of infusion
pumps and controllers
IEC 60601-2-24:1998
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-25:1995 17.5.1997

Particular requirements for the safety of electro-
cardiographs
IEC 60601-2-25:1993
EN 60601-2-25:1995/A1:1999 13.12.2002 Note 3 1.5.2002

IEC 60601-2-25:1993/A1:1999
Cenelec EN 60601-2-26:2003 8.11.2005 EN 60601-2-26:1994 1.3.2006

encephalographs
IEC 60601-2-26:2002
Cenelec EN 60601-2-27:2006 26.7.2006 EN 60601-2-27:1994 1.11.2008

essential performance, of electrocardiographic
monitoring equipment
IEC 60601-2-27:2005
EN 60601-2-27:2006/AC:2006 18.1.2011
Cenelec EN 60601-2-28:2010 18.1.2011 EN 60601-2-28:1993 1.4.2013

essential performance of X-ray tube assemblies
for medical diagnosis
IEC 60601-2-28:2010
Cenelec EN 60601-2-29:2008 15.7.2009 EN 60601-2-29:1999 1.11.2011

essential performance of radiotherapy simulators
IEC 60601-2-29:2008
Cenelec EN 60601-2-30:2000 14.11.2001 EN 60601-2-30:1995 1.2.2003

essential performance, of automatic cycling non-
invasive blood pressure monitoring equipment
IEC 60601-2-30:1999
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-33:2010 This is the first EN 60601-2-33:2002 31.12.2017

Medical electrical equipment — Part 2-33: publication + A1:2005
Particular requirements for the basic safety and + A2:2008
essential performance of magnetic resonance Note 2.1
equipment for medical diagnosis
IEC 60601
IEC 60601-2-33:2010

IEC 60601-2-33:2010/A1:2013 publication

IEC 60601-2-33:2010/A2:2015 publication
EN 60601-2-33:2010/AC:2016-03 This is the first

publication

publication
Cenelec EN 60601-2-34:2000 15.10.2003 EN 60601-2-34:1995 1.11.2003

essential performance, of invasive blood pressure
monitoring equipment
IEC 60601-2-34:2000
Cenelec EN 60601-2-36:1997 9.10.1999

requirements for the safety of equipment for
extracorporeally induced lithotripsy
IEC 60601-2-36:1997
Cenelec EN 60601-2-37:2008 27.11.2008 EN 60601-2-37:2001 1.10.2010

Particular requirements for the basic safety and + A2:2005
essential performance of ultrasonic medical Note 2.1
diagnostic and monitoring equipment
IEC 60601-2-37:2007
Cenelec EN 60601-2-39:2008 27.11.2008 EN 60601-2-39:1999 1.3.2011

Particular requirements for basic safety and
essential performance of peritoneal dialysis
equipment
IEC 60601-2-39:2007
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-40:1998 9.10.1999

myographs and evoked response equipment
IEC 60601-2-40:1998
Cenelec EN 60601-2-41:2009 18.1.2011 EN 60601-2-41:2000 1.11.2012

essential performance of surgical luminaires and
luminaires for diagnosis
IEC 60601-2-41:2009
Cenelec EN 60601-2-43:2010 18.1.2011 EN 60601-2-43:2000 1.6.2013

essential performance of X-ray equipment for
interventional procedures
IEC 60601-2-43:2010
Cenelec EN 60601-2-44:2009 7.7.2010 EN 60601-2-44:2001 1.5.2012

essential performance of X-ray equipment for
computed tomography
IEC 60601-2-44:2009
Cenelec EN 60601-2-45:2001 14.11.2001 EN 60601-2-45:1998 1.7.2004

Particular requirements for the safety of mammo-
graphic X-ray equipment and mammographic
stereotactic devices
IEC 60601-2-45:2001
Cenelec EN 60601-2-46:1998 14.11.2001

Particular requirements for the safety of operating
tables
IEC 60601-2-46:1998
Cenelec EN 60601-2-47:2001 13.12.2002

essential performance, of ambulatory electrocar-
diographic systems
IEC 60601-2-47:2001
(1) (2) (3) (4) (5)
Cenelec EN 60601-2-49:2001 13.12.2002

Particular requirements for the safety of multi-
function patient monitoring equipment
IEC 60601-2-49:2001
Cenelec EN 60601-2-50:2009 7.7.2010 EN 60601-2-50:2002 1.5.2012

essential performance of infant phototherapy
equipment
IEC 60601-2-50:2009
Cenelec EN 60601-2-51:2003 24.6.2004

Particular requirements for safety, including
essential performance, of recording and analysing
single channel and multichannel electrocardio-
graphs
IEC 60601-2-51:2003
Cenelec EN 60601-2-52:2010 13.5.2011 EN 1970:2000 1.6.2012

Particular requirements for basic safety and EN 60601-2-38:1996
essential performance of medical beds (IEC + A1:2000
60601-2-52:2009) Note 2.1
EN 60601-2-52:2010/AC:2011 30.8.2012
Cenelec EN 60601-2-54:2009 18.1.2011 EN 60601-2-7:1998 1.8.2012

Medical electrical equipment — Part 2-54: EN 60601-2-28:1993
Particular requirements for the basic safety and EN 60601-2-32:1994
essential performance of X-ray equipment for Note 2.1
radiography and radioscopy
IEC 60601-2-54:2009
Cenelec EN 60627:2001 13.12.2002

Diagnostic X-ray imaging equipment — Char-
acteristics of general purpose and mammo-
graphic anti-scatter grids
IEC 60627:2001
EN 60627:2001/AC:2002 18.1.2011
Cenelec EN 60645-1:2001 13.12.2002 EN 60645-1:1994 1.10.2004

Electroacoustics — Audiological equipment — Note 2.1
Part 1: Pure-tone audiometers
IEC 60645-1:2001
(1) (2) (3) (4) (5)
Cenelec EN 60645-2:1997 17.5.1997

Audiometers — Part 2: Equipment for speech
audiometry
IEC 60645-2:1993
Cenelec EN 60645-3:2007 27.11.2008 EN 60645-3:1995 1.6.2010

Electroacoustics — Audiometric equipment — Note 2.1
Part 3: Test signals of short duration
IEC 60645-3:2007
Cenelec EN 60645-4:1995 23.8.1996

Audiometers — Part 4: Equipment for extended
high-frequency audiometry
IEC 60645-4:1994
Cenelec EN 61217:2012 30.8.2012 EN 61217:1996 11.1.2015

Radiotherapy equipment — Coordinates, move- + A1:2001
ments and scales + A2:2008
IEC 61217:2011 Note 2.1
Cenelec EN 61676:2002 15.10.2003

Medical electrical equipment — Dosimetric
instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
IEC 61676:2002
EN 61676:2002/A1:2009 7.7.2010 Note 3 1.3.2012

IEC 61676:2002/A1:2008
Cenelec EN 62083:2009 18.1.2011 EN 62083:2001 1.11.2012

Medical electrical equipment — Requirements for Note 2.1
the safety of radiotherapy treatment planning
systems
IEC 62083:2009
Cenelec EN 62220-1:2004 24.6.2004

Medical electrical equipment — Characteristics of
digital X-ray imaging devices — Part 1: Determi-
nation of the detective quantum efficiency
IEC 62220-1:2003
(1) (2) (3) (4) (5)
Cenelec EN 62220-1-2:2007 27.11.2008

digital X-ray imaging devices — Part 1-2:
Determination of the detective quantum effi-
ciency — Detectors used in mammography
IEC 62220-1-2:2007
Cenelec EN 62220-1-3:2008 15.7.2009

digital X-ray imaging devices — Part 1-3:
Determination of the detective quantum effi-
ciency — Detectors used in dynamic imaging
IEC 62220-1-3:2008
Cenelec EN 62304:2006 27.11.2008

processes
IEC 62304:2006
EN 62304:2006/AC:2008 18.1.2011
Cenelec EN 62366:2008 27.11.2008

Medical devices — Application of usability
engineering to medical devices
IEC 62366:2007
Cenelec EN 80601-2-35:2009 18.1.2011 EN 60601-2-35:1996 1.11.2012

essential performance of heating devices using
blankets, pads and mattresses and intended for
heating in medical use
IEC 80601-2-35:2009
Cenelec EN 80601-2-58:2009 7.7.2010

essential performance of lens removal devices
and vitrectomy devices for ophthalmic surgery
IEC 80601-2-58:2008
(1) (2) (3) (4) (5)
Cenelec EN 80601-2-59:2009 18.1.2011

essential performance of screening thermographs
for human febrile temperature screening
IEC 80601
IEC 80601-2-59:2008

legislation.
NOTE:
(1) OJ C 338, 27.9.2014, p. 31.

— More information about harmonised standards and other European standards on the Internet at
Commission communication in the framework of the implementation of the Directive 98/79/EC of

the European Parliament and of the Council on in vitro diagnostic medical devices
(2017/C 389/04)
presumption of
standard
Note 1
(1) (2) (3) (4) (5)
CEN EN 556-1:2001 31.7.2002 EN 556:1994 + 30.4.2002

medical devices
EN 556-1:2001/AC:2006 15.11.2006
CEN EN 556-2:2015 13.5.2016 EN 556-2:2003 30.6.2016

medical devices
CEN EN ISO 11137-1:2015 This is the first

Sterilization of health care products — Radia- publication
CEN EN ISO 11137-2:2015 13.5.2016 EN ISO 11137-2:2013 30.6.2016

(ISO 11137-2:2013)
CEN EN ISO 11737-2:2009 7.7.2010

CEN EN 12322:1999 9.10.1999

In vitro diagnostic medical devices — Culture
media for microbiology — Performance criteria
for culture media
EN 12322:1999/A1:2001 31.7.2002 Note 3 30.4.2002

(1) (2) (3) (4) (5)
CEN EN ISO 13408-1:2015 13.5.2016 EN ISO 13408-1:2011 30.6.2016

CEN EN ISO 13408-2:2011 19.8.2011

CEN EN ISO 13408-3:2011 19.8.2011

CEN EN ISO 13408-4:2011 19.8.2011

4:2005)
CEN EN ISO 13408-5:2011 19.8.2011

CEN EN ISO 13408-6:2011 19.8.2011

CEN EN ISO 13408-7:2015 13.5.2016


(ISO 13485:2016)

publication
CEN EN 13532:2002 17.12.2002

General requirements for in vitro diagnostic
medical devices for self-testing
CEN EN 13612:2002 17.12.2002

Performance evaluation of in vitro diagnostic
medical devices
EN 13612:2002/AC:2002 2.12.2009
CEN EN 13641:2002 17.12.2002

Elimination or reduction of risk of infection
related to in vitro diagnostic reagents
CEN EN 13975:2003 21.11.2003

Sampling procedures used for acceptance testing
of in vitro diagnostic medical devices — Statis-
tical aspects
(1) (2) (3) (4) (5)
CEN EN 14136:2004 15.11.2006

Use of external quality assessment schemes in the
assessment of the performance of in vitro
diagnostic examination procedures
CEN EN 14254:2004 28.4.2005

In vitro diagnostic medical devices — Single-use
receptacles for the collection of specimens, other
than blood, from humans
CEN EN 14820:2004 28.4.2005

Single-use containers for human venous blood
specimen collection
CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 30.4.2010

CEN EN ISO 14971:2012 30.8.2012 EN ISO 14971:2009 30.8.2012

CEN EN ISO 15193:2009 7.7.2010

In vitro diagnostic medical devices — Measure-
ment of quantities in samples of biological
origin — Requirements for content and pre-
sentation of reference measurement procedures
(ISO 15193:2009)
CEN EN ISO 15194:2009 7.7.2010

ment of quantities in samples of biological
origin — Requirements for certified reference
materials and the content of supporting doc-
umentation (ISO 15194:2009)
CEN EN ISO 15197:2015 13.5.2016 EN ISO 15197:2013 31.7.2016

In vitro diagnostic test systems — Requirements Note 2.1
for blood-glucose monitoring systems for self-
testing in managing diabetes mellitus (ISO
15197:2013)
For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be
30.6.2017.
(1) (2) (3) (4) (5)

(ISO 15223-1:2016, Corrected version 2016-12-
15)
CEN EN ISO 17511:2003 28.4.2005

ment of quantities in biological samples —
Metrological traceability of values assigned to
calibrators and control materials (ISO
17511:2003)
CEN EN ISO 18113-1:2011 27.4.2012 EN ISO 18113-1:2009 30.4.2012

In vitro diagnostic medical devices — Informa- Note 2.1
tion supplied by the manufacturer (labelling) —
Part 1: Terms, definitions and general require-
ments (ISO 18113-1:2009)
CEN EN ISO 18113-2:2011 27.4.2012 EN ISO 18113-2:2009 30.4.2012

Part 2: In vitro diagnostic reagents for profes-
sional use (ISO 18113-2:2009)
CEN EN ISO 18113-3:2011 27.4.2012 EN ISO 18113-3:2009 30.4.2012

Part 3: In vitro diagnostic instruments for
professional use (ISO 18113-3:2009)
CEN EN ISO 18113-4:2011 27.4.2012 EN ISO 18113-4:2009 30.4.2012

Part 4: In vitro diagnostic reagents for self-testing
(ISO 18113-4:2009)
CEN EN ISO 18113-5:2011 27.4.2012 EN ISO 18113-5:2009 30.4.2012

Part 5: In vitro diagnostic instruments for self-
testing (ISO 18113-5:2009)
CEN EN ISO 18153:2003 21.11.2003

ment of quantities in biological samples —
Metrological traceability of values for catalytic
concentration of enzymes assigned to calibrators
and control materials (ISO 18153:2003)
(1) (2) (3) (4) (5)
CEN EN ISO 20776-1:2006 9.8.2007

Clinical laboratory testing and in vitro diagnostic
test systems — Susceptibility testing of infectious
agents and evaluation of performance of anti-
microbial susceptibility test devices — Part 1:
Reference method for testing the in vitro activity
of antimicrobial agents against rapidly growing
aerobic bacteria involved in infectious diseases
(ISO 20776-1:2006)
CEN EN ISO 23640:2015 13.5.2016 EN 13640:2002 30.6.2017

In vitro diagnostic medical devices — Evaluation Note 2.1
of stability of in vitro diagnostic reagents (ISO
23640:2011)
Cenelec EN 61010-2-101:2002 17.12.2002

Safety requirements for electrical equipment for
measurement, control, and laboratory use —
Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
IEC 61010-2-101:2002 (Modified)
Cenelec EN 61326-2-6:2006 27.11.2008

Electrical equipment for measurement, control
and laboratory use — EMC requirements —
Part 2-6: Particular requirements — In vitro
diagnostic (IVD) medical equipment
IEC 61326-2-6:2005
Cenelec EN 62304:2006 27.11.2008

processes
IEC 62304:2006
EN 62304:2006/AC:2008 18.1.2011
Cenelec EN 62366:2008 27.11.2008

Medical devices — Application of usability
engineering to medical devices
IEC 62366:2007

legislation.
NOTE:
— More information about harmonised standards and other European standards on the Internet at
(1) OJ C 338, 27.9.2014, p. 31.

Commission communication in the framework of the implementation of Directive 1999/5/EC of the

European Parliament and of the Council on radio equipment and telecommunications terminal
equipment and the mutual recognition of their conformity and Directive 2014/53/EU of the
European Parliament and of the Council on the harmonisation of the laws of the Member States
relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
(2017/C 389/05)
Directive 1999/5/EC
In accordance with the transitional provision of Article 48 of Directive 2014/53/EU (1), Member States shall not impede the
making available on the market or putting into service of radio equipment covered by Directive 2014/53/EU which is in
conformity with Directive 1999/5/EC (2) and which was placed on the market before 13 June 2017. Accordingly,
harmonised standards the references to which have been published under Directive 1999/5/EC, as lastly listed in
Commission Communication published in the Official Journal of the European Union C 249 of 8 July 2016, p. 1, and corrected
by Corrigendum published in the Official Journal of the European Union C 342 of 17 September 2016, p. 15, and Corrigendum
published in the Official Journal of the European Union C 403 of 1 November 2016, p. 26, continue to confer a presumption of
conformity with that Directive until 12 June 2017.
Directive 2014/53/EU
presumption of Standard aims to cover
Reference and title of the standard Reference of
ESO (1) First publication OJ conformity of Article(s) of Directive
(and reference document) superseded standard
superseded standard 2014/53/EU
Note 1
(1) (2) (3) (4) (5) (6)
Cenelec EN 50360:2017 This is the first Article 3(1)(a)

Product standard to demonstrate the publication
compliance of wireless communication
devices, with the basic restrictions and
exposure limit values related to human
exposure to electromagnetic fields in
the frequency range from 300 MHz to
6 GHz: devices used next to the ear

compliance of base station equipment
with radiofrequency electromagnetic
field exposure limits (110 MHz —
100 GHz), when placed on the market
(1) OJ L 153, 22.5.2014, p. 62.

(2) OJ L 91, 7.4.1999, p. 10.
(1) (2) (3) (4) (5) (6)

compliance of base station equipment
with radiofrequency electromagnetic
field exposure limits (110 MHz —
100 GHz), when put into service

compliance of wireless communication
devices with the basic restrictions and
exposure limit values related to human
exposure to electromagnetic fields in
the frequency range from 30 MHz to
6 GHz: hand-held and body mounted
devices in close proximity to the human
body
Cenelec EN 55035:2017 This is the first Article 3(1)(b)

Electromagnetic compatibility of multi- publication
media equipment — Immunity require-
ments
CISPR 35:2016 (Modified)
ETSI EN 300 065 V2.1.2 8.7.2016 Article 3(2); Arti-

Narrow-band direct-printing telegraph cle 3(3)(g)
equipment for receiving meteorological
or navigational information (NAVTEX);
Harmonised Standard covering the
essential requirements of articles 3.2
and 3.3(g) of the Directive 2014/53/EU
ETSI EN 300 086 V2.1.2 9.12.2016 Article 3(2)

Land Mobile Service; Radio equipment
with an internal or external RF con-
nector intended primarily for analogue
speech; Harmonised Standard covering
the essential requirements of article 3.2
of the Directive 2014/53/EU
ETSI EN 300 113 V2.2.1 12.4.2017 Article 3(2)

intended for the transmission of data
(and/or speech) using constant or non-
constant envelope modulation and hav-
ing an antenna connector; Harmonised
Standard covering the essential require-
ments of article 3.2 of the Directive
2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 300 219 V2.1.1 12.4.2017 Article 3(2)

transmitting signals to initiate a specific
response in the receiver; Harmonised
2014/53/EU
ETSI EN 300 220-2 V3.1.1 10.3.2017 Article 3(2)

Short Range Devices (SRD) operating in
the frequency range 25 MHz to
1 000 MHz; Part 2: Harmonised Stan-
dard covering the essential require-
ments of article 3.2 of Directive 2014/
53/EU for non specific radio equipment
ETSI EN 300 220-3-1 V2.1.1 10.3.2017 Article 3(2)

1 000 MHz; Part 3-1: Harmonised
53/EU; Low duty cycle high reliability
equipment, social alarms equipment
operating on designated frequencies
(869,200 MHz to 869,250 MHz)
ETSI EN 300 220-3-2 V1.1.1 10.3.2017 Article 3(2)

1 000 MHz; Part 3-2: Harmonised
53/EU; Wireless alarms operating in
designated LDC/HR frequency bands
868,60 MHz to 868,70 MHz,
869,25 MHz to 869,40 MHz,
869,65 MHz to 869,70 MHz
ETSI EN 300 220-4 V1.1.1 10.3.2017 Article 3(2)

1 000 MHz; Part 4: Harmonised Stan-
53/EU; Metering devices operating in
designated band 169,400 MHz to
169,475 MHz
(1) (2) (3) (4) (5) (6)
ETSI EN 300 224 V2.1.1 13.10.2017 EN 300 224-2 28.2.2019 Article 3(2)
Land Mobile Service; Radio Equipment V1.1.1
for use in a Paging Service operating Note 2.1
within the frequency range 25 MHz —
470 MHz; Harmonised Standard cover-
ing the essential requirements of arti-
cle 3.2 of Directive 2014/53/EU
ETSI EN 300 224-2 V1.1.1 8.6.2017 Article 3(2)

Electromagnetic compatibility and
Radio spectrum Matters (ERM); On-site
paging service; Part 2: Harmonized EN
under article 3.2 of the R&TTE Direc-
tive
This harmonised standard does not address requirements relating to receiver performance parameters and does not confer a presumption
of conformity as regards those parameters.
ETSI EN 300 296 V2.1.1 12.4.2017 Article 3(2)

using integral antennas intended pri-
marily for analogue speech; Harmo-
nised Standard covering the essential
requirements of article 3.2 of the
ETSI EN 300 328 V2.1.1 13.1.2017 Article 3(2)

Wideband transmission systems; Data
transmission equipment operating in
the 2,4 GHz ISM band and using wide
band modulation techniques; Harmo-
requirements of article 3.2 of Directive
2014/53/EU
ETSI EN 300 330 V2.1.1 10.3.2017 Article 3(2)

Short Range Devices (SRD); Radio
equipment in the frequency range
9 kHz to 25 MHz and inductive loop
systems in the frequency range 9 kHz to
30 MHz; Harmonised Standard cover-
cle 3.2 of Directive 2014/53/EU
ETSI EN 300 341 V2.1.1 12.4.2017 Article 3(2)

using an integral antenna transmitting
signals to initiate a specific response in
the receiver; Harmonised Standard cov-
ering the essential requirements of
article 3.2 of the Directive 2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 300 390 V2.1.1 12.4.2017 Article 3(2)

intended for the transmission of data
(and speech) and using an integral
antenna; Harmonised Standard cover-
cle 3.2 of the Directive 2014/53/EU
ETSI EN 300 422-1 V2.1.2 10.2.2017 Article 3(2)

Wireless Microphones; Audio PMSE up
to 3 GHz; Part 1: Class A Receivers;
essential requirements of article 3.2 of
ETSI EN 300 422-2 V2.1.1 10.3.2017 Article 3(2)

to 3 GHz; Part 2: Class B Receivers;
ETSI EN 300 422-3 V2.1.1 10.3.2017 Article 3(2)

to 3 GHz; Part 3: Class C Receivers;
ETSI EN 300 433 V2.1.1 12.4.2017 Article 3(2)

Citizens' Band (CB) radio equipment;
the Directive 2014/53/EU
Short Range Devices (SRD); Radio V1.4.1
equipment to be used in the 1 GHz to Note 2.1
40 GHz frequency range; Harmonised
53/EU
This harmonised standard does not address, for receiver categories 2 and 3 as defined in Table 5, the requirements relating to receiver
performance parameters and does not confer a presumption of conformity as regards those parameters.
(1) (2) (3) (4) (5) (6)
ETSI EN 300 440-2 V1.4.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Short
range devices; Radio equipment to be
used in the 1 GHz to 40 GHz frequency
range; Part 2: Harmonized EN covering
of the R&TTE Directive
ETSI EN 300 454-2 V1.1.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Wide
band audio links; Part 2: Harmonized
EN under article 3.2 of the R&TTE
Directive
ETSI EN 300 487 V2.1.2 13.1.2017 Article 3(2)

Satellite Earth Stations and Systems
(SES); Harmonised Standard for Re-
ceive-Only Mobile Earth Stations
(ROMES) providing data communica-
tions operating in the 1,5 GHz fre-
quency band; Radio Frequency (RF)
specifications covering the essential
ETSI EN 300 676-2 V2.1.1 8.7.2016 Article 3(2)

Ground-based VHF hand-held, mobile
and fixed radio transmitters, receivers
and transceivers for the VHF aeronau-
tical mobile service using amplitude
modulation; Part 2: Harmonised Stan-
2014/53/EU

Radio telephone transmitters and recei- cle 3(3)(g)
vers for the maritime mobile service
operating in the VHF bands used on
inland waterways; Harmonised Stan-
ments of articles 3.2 and 3.3(g) of the
(1) (2) (3) (4) (5) (6)
ETSI EN 300 718-2 V1.1.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Ava-
lanche Beacons; Transmitter-receiver
systems; Part 2: Harmonized EN cover-
ing essential requirements of article 3.2
ETSI EN 300 718-3 V1.2.1 8.6.2017 Article 3(3)(g)

Radio spectrum Matters (ERM); Ava-
lanche Beacons; Transmitter-receiver
systems; Part 3: Harmonized EN cover-
ing essential requirements of article 3.3e
ETSI EN 300 720 V2.1.1 10.3.2017 Article 3(2)

Ultra-High Frequency (UHF) on-board
vessels communications systems and
equipment; Harmonised Standard cov-

VHF radiotelephone equipment for cle 3(3)(g)
general communications and associated
equipment for Class ‘D’ Digital Selective
Calling (DSC); Harmonised Standard
covering the essential requirements of
articles 3.2 and 3.3(g) of the Directive
2014/53/EU
ETSI EN 301 025 V2.2.1 12.4.2017 EN 301 025 30.11.2018 Article 3(2); Arti-
VHF radiotelephone equipment for V2.1.1 cle 3(3)(g)
general communications and associated Note 2.1
equipment for Class ‘D’ Digital Selective
Calling (DSC); Harmonised Standard
articles 3.2 and 3.3(g) of Directive
2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 301 091-2 V1.3.2 8.6.2017 Article 3(2)

Range Devices; Road Transport and
Traffic Telematics (RTTT); Radar equip-
ment operating in the 76 GHz to
77 GHz range; Part 2: Harmonized EN
covering essential requirements of arti-
cle 3.2 of the R&TTE Directive
ETSI EN 301 166 V2.1.1 10.2.2017 Article 3(2)

for analogue and/or digital communica-
tion (speech and/or data) and operating
on narrow band channels and having an
antenna connector; Harmonised Stan-
2014/53/EU
ETSI EN 301 178 V2.2.2 12.5.2017 Article 3(2)

Portable Very High Frequency (VHF)
radiotelephone equipment for the mar-
itime mobile service operating in the
VHF bands (for non-GMDSS applica-
tions only); Harmonised Standard cov-
article 3.2 of Directive 2014/53/EU
Cordless audio devices in the range V1.4.1
25 MHz to 2 000 MHz; Harmonised Note 2.1
53/EU
ETSI EN 301 357-2 V1.4.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Cord-
less audio devices in the range 25 MHz
to 2 000 MHz; Part 2: Harmonized EN
(1) (2) (3) (4) (5) (6)
ETSI EN 301 360 V2.1.1 11.11.2016 Article 3(2)

(SES); Harmonised Standard for Satellite
Interactive Terminals (SIT) and Satellite
User Terminals (SUT) transmitting to-
wards satellites in geostationary orbit,
operating in the 27,5 GHz to 29,5 GHz
frequency bands covering the essential
ETSI EN 301 406 V2.2.2 11.11.2016 Article 3(2)

Digital Enhanced Cordless Telecommu-
nications (DECT); Harmonised Standard
ETSI EN 301 426 V2.1.2 13.1.2017 Article 3(2)

(SES); Harmonised Standard for Low
data rate Land Mobile satellite Earth
Stations (LMES) and Maritime Mobile
satellite Earth Stations (MMES) not
intended for distress and safety com-
munications operating in the 1,5 GHz/
1,6 GHz frequency bands covering the
ETSI EN 301 427 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for low
data rate Mobile satellite Earth Stations
(MES) except aeronautical mobile satel-
lite earth stations, operating in the 11/
12/14 GHz frequency bands covering
ETSI EN 301 428 V2.1.2 8.6.2017 Article 3(2)

(SES); Harmonised Standard for Very
Small Aperture Terminal (VSAT); Trans-
mit-only, transmit/receive or receive-
only satellite earth stations operating
in the 11/12/14 GHz frequency bands
(1) (2) (3) (4) (5) (6)
ETSI EN 301 430 V2.1.1 14.10.2016 Article 3(2)

News Gathering Transportable Earth
Stations (SNG TES) operating in the
11 GHz to 12 GHz/13 GHz to 14 GHz
ETSI EN 301 441 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for Mobile
Earth Stations (MES), including hand-
held earth stations, for Satellite Personal
Communications Networks (S-PCN) op-
erating in the 1,6 GHz/2,4 GHz fre-
quency band under the Mobile Satellite
Service (MSS) covering the essential
ETSI EN 301 442 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for NGSO
Mobile Earth Stations (MES) including
handheld earth stations, for Satellite
Personal Communications Networks (S-
PCN) operating in the 1 980 MHz to
2 010 MHz (earth-to-space) and
2 170 MHz to 2 200 MHz (space-to-
earth) frequency bands under the Mo-
bile Satellite Service (MSS) covering the
ETSI EN 301 443 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for Very
Small Aperture Terminal (VSAT); Trans-
mit-only, transmit-and-receive, receive-
only satellite earth stations operating in
the 4 GHz and 6 GHz frequency bands
(1) (2) (3) (4) (5) (6)
ETSI EN 301 444 V2.1.2 13.1.2017 Article 3(2)

(SES); Harmonised Standard for Land
Mobile Earth Stations (LMES) providing
voice and/or data communications,
operating in the 1,5 GHz and 1,6 GHz
ETSI EN 301 447 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for satellite
Earth Stations on board Vessels (ESVs)
operating in the 4/6 GHz frequency
bands allocated to the Fixed Satellite
Service (FSS) covering the essential
ETSI EN 301 459 V2.1.1 14.10.2016 Article 3(2)

Interactive Terminals (SIT) and Satellite
User Terminals (SUT) transmitting to-
wards satellites in geostationary orbit,
operating in the 29,5 GHz to 30,0 GHz
ETSI EN 301 473 V2.1.2 13.1.2017 Article 3(2)

(SES); Harmonised Standard for Aircraft
Earth Stations (AES) providing Aero-
nautical Mobile Satellite Service
(AMSS)/Mobile Satellite Service (MSS)
and/or the Aeronautical Mobile Satellite
on Route Service (AMS(R)S)/Mobile
Satellite Service (MSS), operating in the
frequency band below 3 GHz covering
ETSI EN 301 502 V12.5.2 12.4.2017 Article 3(2)

Global System for Mobile communica-
tions (GSM); Base Station (BS) equip-
ment; Harmonised Standard covering
of Directive 2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 301 511 V9.0.2 12.4.2017 Article 3(2)

tions (GSM); Harmonized EN for mobile
stations in the GSM 900 and GSM 1800
bands covering essential requirements
under article 3.2 of the R&TTE directive
(1999/5/EC)
Notice: This harmonised standard provides presumption of conformity with the essential requirements of Directive 2014/53/EU if also
the receiving parameters in clause(s) 4.2.20, 4.2.21 and 4.2.26 are applied
ETSI EN 301 559 V2.1.1 13.1.2017 Article 3(2)

Short Range Devices (SRD); Low Power
Active Medical Implants (LP-AMI) and
associated Peripherals (LP-AMI-P) oper-
ating in the frequency range
2 483,5 MHz to 2 500 MHz; Harmo-
ETSI EN 301 598 V1.1.1 8.6.2017 Article 3(2)

White Space Devices (WSD); Wireless
Access Systems operating in the
470 MHz to 790 MHz TV broadcast
band; Harmonized EN covering the
the R&TTE Directive
ETSI EN 301 681 V2.1.2 13.1.2017 Article 3(2)

Earth Stations (MES) of Geostationary
mobile satellite systems, including
handheld earth stations, for Satellite
Personal Communications Networks (S-
PCN) under the Mobile Satellite Service
(MSS), operating in the 1,5 GHz and
1,6 GHz frequency bands covering the
(1) (2) (3) (4) (5) (6)
ETSI EN 301 721 V2.1.1 12.4.2017 Article 3(2)

Earth Stations (MES) providing Low Bit
Rate Data Communications (LBRDC)
using Low Earth Orbiting (LEO) satel-
lites operating below 1 GHz frequency
band covering the essential require-
2014/53/EU
ETSI EN 301 783 V2.1.1 8.7.2016 Article 3(2)

Commercially available amateur radio
ETSI EN 301 839 V2.1.1 8.7.2016 Article 3(2)

Ultra Low Power Active Medical Im-
plants (ULP-AMI) and associated Per-
ipherals (ULP-AMI-P) operating in the
frequency range 402 MHz to 405 MHz;
ETSI EN 301 841-3 V2.1.1 13.1.2017 Article 3(2)

VHF air-ground Digital Link (VDL)
Mode 2; Technical characteristics and
methods of measurement for ground-
based equipment; Part 3: Harmonised
2014/53/EU
ETSI EN 301 842-5 V2.1.1 13.1.2017 Article 3(2)

VHF air-ground Digital Link (VDL)
Mode 4 radio equipment; Technical
characteristics and methods of measure-
ment for ground-based equipment; Part
5: Harmonised Standard covering the
ETSI EN 301 893 V1.8.1 8.6.2017 Article 3(2)

Broadband Radio Access Networks
(BRAN); 5 GHz high performance
RLAN; Harmonized EN covering the
the R&TTE Directive
(1) (2) (3) (4) (5) (6)
ETSI EN 301 893 V2.1.1 8.6.2017 EN 301 893 12.6.2018 Article 3(2)
5 GHz RLAN; Harmonised Standard V1.8.1
covering the essential requirements of Note 2.1
As regards adaptivity, until 12.6.2018, either clause 4.2.7 of this harmonised standard or clause 4.8 of harmonised standard EN 301 893
v1.8.1 may be used; after that date, only clause 4.2.7 of this harmonised standard may be used.
ETSI EN 301 908-1 V11.1.1 9.12.2016 Article 3(2)

IMT cellular networks; Harmonised
2014/53/EU; Part 1: Introduction and
common requirements
ETSI EN 301 908-2 V11.1.1 12.4.2017 Article 3(2)

2014/53/EU; Part 2: CDMA Direct
Spread (UTRA FDD) User Equipment
(UE)
ETSI EN 301 908-2 V11.1.2 13.10.2017 EN 301 908-2 28.2.2019 Article 3(2)
IMT cellular networks; Harmonised V11.1.1
Standard covering the essential require- Note 2.1
53/EU; Part 2: CDMA Direct Spread
(UTRA FDD) User Equipment (UE)
ETSI EN 301 908-3 V11.1.3 12.5.2017 Article 3(2)

53/EU; Part 3: CDMA Direct Spread
(UTRA FDD) Base Stations (BS)
ETSI EN 301 908-10 V4.2.2 13.1.2017 Article 3(2)

Radio spectrum Matters (ERM); Base
Stations (BS), Repeaters and User Equip-
ment (UE) for IMT-2000 Third-Gener-
ation cellular networks; Part 10:
Harmonised Standard for IMT-2000,
FDMA/TDMA (DECT) covering the
(1) (2) (3) (4) (5) (6)
ETSI EN 301 908-11 V11.1.2 10.2.2017 Article 3(2)

2014/53/EU; Part 11: CDMA Direct
Spread (UTRA FDD) Repeaters
ETSI EN 301 908-12 V7.1.1 9.9.2016 Article 3(2)

2014/53/EU; Part 12: CDMA Multi-
Carrier (cdma2000) Repeaters
ETSI EN 301 908-13 V11.1.1 12.5.2017 Article 3(2)

2014/53/EU; Part 13: Evolved Universal
Terrestrial Radio Access (E-UTRA) User
Equipment (UE)
ETSI EN 301 908-13 V11.1.2 13.10.2017 EN 301 908-13 28.2.2019 Article 3(2)
IMT cellular networks; Harmonised V11.1.1
Standard covering the essential require- Note 2.1
53/EU; Part 13: Evolved Universal
Terrestrial Radio Access (E-UTRA) User
Equipment (UE)
ETSI EN 301 908-14 V11.1.2 12.5.2017 Article 3(2)

Terrestrial Radio Access (E-UTRA) Base
Stations (BS)
ETSI EN 301 908-15 V11.1.2 10.2.2017 Article 3(2)

Terrestrial Radio Access (E-UTRA
FDD) Repeaters
ETSI EN 301 908-18 V11.1.2 12.5.2017 Article 3(2)

53/EU; Part 18: E-UTRA, UTRA and
GSM/EDGE Multi-Standard Radio
(MSR) Base Station (BS)
(1) (2) (3) (4) (5) (6)
ETSI EN 301 908-19 V6.3.1 8.6.2017 Article 3(2)

2014/53/EU; Part 19: OFDMA TDD
WMAN (Mobile WiMAXTM) TDD User
Equipment (UE)
ETSI EN 301 908-20 V6.3.1 14.10.2016 Article 3(2)

WMAN (Mobile WiMAXTM) TDD Base
Stations (BS)
ETSI EN 301 908-21 V6.1.1 14.10.2016 Article 3(2)

WMAN (Mobile WiMAXTM) FDD User
Equipment (UE)
ETSI EN 301 908-22 V6.1.1 9.12.2016 Article 3(2)

WMAN (Mobile WiMAXTM) FDD Base
Stations (BS)
ETSI EN 301 929 V2.1.1 12.4.2017 Article 3(2)

VHF transmitters and receivers as Coast
Stations for GMDSS and other applica-
tions in the maritime mobile service;
ETSI EN 302 017 V2.1.1 12.5.2017 Article 3(2)

Transmitting equipment for the Ampli-
tude Modulated (AM) sound broadcast-
ing service; Harmonised Standard
Transmitting equipment for the Fre- V1.2.1
quency Modulated (FM) sound broad- Note 2.1
casting service; Harmonised Standard
(1) (2) (3) (4) (5) (6)
ETSI EN 302 018-2 V1.2.1 12.4.2017 Article 3(2)

Radio spectrum Matters (ERM); Trans-
mitting equipment for the Frequency
Modulated (FM) sound broadcasting
service; Part 2: Harmonized EN under
article 3.2 of the R&TTE Directive
ETSI EN 302 054-2 V1.2.1 13.1.2017 Article 3(2)

Meteorological Aids (Met Aids); Radio-
sondes to be used in the 400,15 MHz to
406 MHz frequency range with power
levels ranging up to 200 mW; Part 2:
ETSI EN 302 064-2 V1.1.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Wireless
Video Links (WVL) operating in the
1,3 GHz to 50 GHz frequency band;
Part 2: Harmonized EN under article 3.2
ETSI EN 302 065-1 V2.1.1 10.3.2017 Article 3(2)

Short Range Devices (SRD) using Ultra
Wide Band technology (UWB); Harmo-
Directive 2014/53/EU; Part 1: Require-
ments for Generic UWB applications
ETSI EN 302 065-2 V2.1.1 10.3.2017 Article 3(2)

ments for UWB location tracking
ETSI EN 302 065-3 V2.1.1 10.3.2017 Article 3(2)

ments for UWB devices for ground
based vehicular applications
(1) (2) (3) (4) (5) (6)
ETSI EN 302 065-4 V1.1.1 12.4.2017 Article 3(2)

Directive 2014/53/EU; Part 4: Material
Sensing devices using UWB technology
below 10,6 GHz
ETSI EN 302 066-2 V1.2.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM);
Ground- and Wall-Probing Radar appli-
cations (GPR/WPR) imaging systems;
Part 2: Harmonized EN covering essen-
tial requirements of article 3.2 of the
R&TTE Directive
ETSI EN 302 077-2 V1.1.1 12.4.2017 Article 3(2)

mitting equipment for the Terrestrial —
Digital Audio Broadcasting (T-DAB)
service; Part 2: Harmonized EN under
ETSI EN 302 186 V2.1.1 12.4.2017 Article 3(2)

mobile Aircraft Earth Stations (AESs)
operating in the 11/12/14 GHz fre-
quency bands covering the essential
ETSI EN 302 194-2 V1.1.2 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Naviga-
tion radar used on inland waterways;
Part 2: Harmonized EN covering essen-
tial requirements of article 3.2 of the
R&TTE Directive
(1) (2) (3) (4) (5) (6)
ETSI EN 302 195 V2.1.1 11.11.2016 Article 3(2)

Short Range Devices (SRD); Ultra Low
Power Active Medical Implants (ULP-
AMI) and accessories (ULP-AMI-P) op-
erating in the frequency range 9 kHz to
315 kHz Harmonised Standard cover-
ETSI EN 302 208 V3.1.1 12.4.2017 Article 3(2)

Radio Frequency Identification Equip-
ment operating in the band 865 MHz to
868 MHz with power levels up to 2 W
and in the band 915 MHz to 921 MHz
with power levels up to 4 W; Harmo-
ETSI EN 302 217-2 V3.1.1 8.6.2017 EN 302 217-2-2 31.12.2018 Article 3(2)
Fixed Radio Systems; Characteristics V2.2.1
and requirements for point-to-point Note 2.1
equipment and antennas; Part 2: Digital
systems operating in frequency bands
from 1 GHz to 86 GHz; Harmonised
53/EU
ETSI EN 302 217-2-2 V2.2.1 12.4.2017 Article 3(2)

Fixed Radio Systems; Characteristics
and requirements for point-to-point
equipment and antennas; Part 2-2:
Digital systems operating in frequency
bands where frequency coordination is
applied; Harmonized EN covering the
the R&TTE Directive
Notice: This harmonised standard provides presumption of conformity with the essential requirements of Directive 2014/53/EU if also
the receiving parameters in clause(s) 4.3.1, 4.3.2, 4.3.3 and 4.3.4 are applied
ETSI EN 302 245-2 V1.1.1 12.4.2017 Article 3(2)

mitting equipment for the Digital Radio
Mondiale (DRM) broadcasting service
Part 2: Harmonized EN under article 3.2
(1) (2) (3) (4) (5) (6)
ETSI EN 302 248 V2.1.1 10.3.2017 Article 3(2)

Navigation radar for use on non-SOLAS
vessels; Harmonised Standard covering
ETSI EN 302 264-2 V1.1.1 8.6.2017 Article 3(2)

Traffic Telematics (RTTT); Short Range
Radar equipment operating in the
77 GHz to 81 GHz band; Part 2:
Harmonized EN covering the essential
R&TTE Directive
ETSI EN 302 288-2 V1.6.1 8.6.2017 Article 3(2)

Traffic Telematics (RTTT); Short range
radar equipment operating in the
24 GHz range; Part 2: Harmonized EN
ETSI EN 302 296-2 V1.2.1 12.4.2017 Article 3(2)

mitting equipment for the digital tele-
vision broadcast service, Terrestrial
(DVB-T); Part 2: Harmonized EN cover-
ETSI EN 302 326-2 V1.2.2 12.4.2017 Article 3(2)

Fixed Radio Systems; Multipoint Equip-
ment and Antennas; Part 2: Harmo-
nized EN covering the essential
R&TTE Directive for Digital Multipoint
Radio Equipment
(1) (2) (3) (4) (5) (6)
ETSI EN 302 340 V2.1.1 12.4.2017 Article 3(2)

Earth Stations on board Vessels (ESVs)
operating in the 11/12/14 GHz fre-
quency bands allocated to the Fixed
Satellite Service (FSS) covering the
ETSI EN 302 372 V2.1.1 10.3.2017 Article 3(2)

Short Range Devices (SRD); Tank Level
Probing Radar (TLPR) equipment oper-
ating in the frequency ranges 4,5 GHz
to 7 GHz, 8,5 GHz to 10,6 GHz,
24,05 GHz to 27 GHz, 57 GHz to
64 GHz, 75 GHz to 85 GHz; Harmo-
ETSI EN 302 448 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for track-
ing Earth Stations on Trains (ESTs)
bands covering the essential require-
2014/53/EU
ETSI EN 302 454-2 V1.2.1 13.1.2017 Article 3(2)

Meteorological Aids (Met Aids); Radio-
sondes to be used in the 1 668,4 MHz
to 1 690 MHz frequency range; Part 2:
ETSI EN 302 480 V2.1.2 10.3.2017 Article 3(2)

Mobile Communication On Board Air-
craft (MCOBA) systems; Harmonised
53/EU
ETSI EN 302 502 V2.1.1 12.5.2017 Article 3(2)

Wireless Access Systems (WAS);
5,8 GHz fixed broadband data transmit-
ting systems; Harmonised Standard
(1) (2) (3) (4) (5) (6)
ETSI EN 302 510-2 V1.1.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Radio
equipment in the frequency range
30 MHz to 37,5 MHz for Ultra Low
Power Active Medical Membrane Im-
plants and Accessories; Part 2: Harmo-
nized EN covering essential
R&TTE Directive
ETSI EN 302 536-2 V1.1.1 8.6.2017 Article 3(2)

Range Devices (SRD); Radio equipment
in the frequency range 315 kHz to
600 kHz; Part 2: Harmonized EN
ETSI EN 302 537 V2.1.1 13.1.2017 Article 3(2)

Ultra Low Power Medical Data Service
(MEDS) Systems operating in the fre-
quency range 401 MHz to 402 MHz
and 405 MHz to 406 MHz; Harmonised
2014/53/EU
ETSI EN 302 561 V2.1.1 12.4.2017 Article 3(2)

using constant or non-constant envel-
ope modulation operating in a channel
bandwidth of 25 kHz, 50 kHz, 100 kHz
or 150 kHz; Harmonised Standard
ETSI EN 302 567 V1.2.1 8.6.2017 Article 3(2)

Broadband Radio Access Networks
(BRAN); 60 GHz Multiple-Gigabit
WAS/RLAN Systems; Harmonized EN
(1) (2) (3) (4) (5) (6)
ETSI EN 302 571 V2.1.1 8.6.2017 Article 3(2)

Intelligent Transport Systems (ITS);
Radiocommunications equipment oper-
ating in the 5 855 MHz to 5 925 MHz
frequency band; Harmonised Standard
ETSI EN 302 574-1 V2.1.2 12.4.2017 Article 3(2)

Earth Stations (MES) operating in the
1 980 MHz to 2 010 MHz (earth-to-
space) and 2 170 MHz to 2 200 MHz
(space-to-earth) frequency bands cover-
cle 3.2 of the Directive 2014/53/EU;
Part 1: Complementary Ground Com-
ponent (CGC) for wideband systems
ETSI EN 302 574-2 V2.1.2 12.4.2017 Article 3(2)

Part 2: User Equipment (UE) for wide-
band systems
ETSI EN 302 574-3 V2.1.1 12.4.2017 Article 3(2)

Part 3: User Equipment (UE) for nar-
rowband systems
(1) (2) (3) (4) (5) (6)
ETSI EN 302 608 V1.1.1 8.6.2017 Article 3(2)

for Eurobalise railway systems; Harmo-
nized EN covering the essential require-
ments of article 3.2 of the R&TTE
Directive
ETSI EN 302 609 V2.1.1 8.6.2017 Article 3(2)

Short Range Devices (SRD); Radio
equipment for Euroloop railway sys-
tems; Harmonised Standard covering
ETSI EN 302 617-2 V2.1.1 13.1.2017 Article 3(2)

Ground-based UHF radio transmitters,
receivers and transceivers for the UHF
aeronautical mobile service using am-
plitude modulation; Part 2: Harmonised
2014/53/EU
ETSI EN 302 686 V1.1.1 8.6.2017 Article 3(2)

Intelligent Transport Systems (ITS);
Radiocommunications equipment oper-
ating in the 63 GHz to 64 GHz
frequency band; Harmonized EN cover-
ETSI EN 302 729 V2.1.1 12.5.2017 Article 3(2)

Short Range Devices (SRD); Level Prob-
ing Radar (LPR) equipment operating in
the frequency ranges 6 GHz to 8,5 GHz,
24,05 GHz to 26,5 GHz, 57 GHz to
64 GHz, 75 GHz to 85 GHz; Harmo-
(1) (2) (3) (4) (5) (6)
ETSI EN 302 752 V1.1.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Active
radar target enhancers; Harmonized EN
ETSI EN 302 858-2 V1.3.1 8.6.2017 Article 3(2)

Radio spectrum Matters (ERM); Road
Transport and Traffic Telematics
(RTTT); Automotive radar equipment
operating in the 24,05 GHz up to
24,25 GHz or 24,50 GHz frequency
range; Part 2: Harmonized EN covering

Portable Very High Frequency (VHF) cle 3(3)(g)
radiotelephone equipment for the mar-
VHF bands with integrated handheld
class D DSC; Harmonised Standard
articles 3.2 and 3.3(g) of the Directive
2014/53/EU
Portable Very High Frequency (VHF) V2.1.1 cle 3(3)(g)
radiotelephone equipment for the mar- Note 2.1
class H DSC; Harmonised Standard
2014/53/EU
Portable Very High Frequency (VHF) V2.2.2 cle 3(3)(g)
radiotelephone equipment for the mar- Note 2.1
class H DSC; Harmonised Standard
2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 302 961 V2.1.2 11.11.2016 Article 3(2)

Maritime Personal Homing Beacon in-
tended for use on the frequency
121,5 MHz for search and rescue
purposes only; Harmonised Standard
ETSI EN 302 977 V2.1.1 12.4.2017 Article 3(2)

(SES); Harmonised Standard for Vehi-
cle-Mounted Earth Stations (VMES)
bands covering the essential require-
2014/53/EU
ETSI EN 303 039 V2.1.2 11.11.2016 Article 3(2)

Land Mobile Service; Multichannel
transmitter specification for the PMR
Service; Harmonised Standard covering
ETSI EN 303 084 V2.1.1 11.11.2016 Article 3(2)

Ground Based Augmentation System
(GBAS) VHF ground-air Data Broadcast
(VDB); Technical characteristics and
methods of measurement for ground-
based equipment; Harmonised Standard
ETSI EN 303 098 V2.1.1 13.1.2017 Article 3(2)

Maritime low power personal locating
devices employing AIS; Harmonised
2014/53/EU
ETSI EN 303 132 V1.1.1 12.5.2017 Article 3(2)

Maritime low power VHF personal
locating beacons employing Digital
Selective Calling (DSC); Harmonised
53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 303 135 V2.1.1 13.1.2017 Article 3(2)

Radio spectrum Matters (ERM); Coastal
Surveillance, Vessel Traffic Services and
Harbour Radars (CS/VTS/HR); Harmo-
ETSI EN 303 203 V2.1.1 12.8.2016 Article 3(2)

Short Range Devices (SRD); Medical
Body Area Network Systems (MBANSs)
operating in the 2 483,5 MHz to
2 500 MHz range; Harmonised Stan-
2014/53/EU
ETSI EN 303 204 V2.1.2 11.11.2016 Article 3(2)

Network Based Short Range Devices
(SRD); Radio equipment to be used in
the 870 MHz to 876 MHz frequency
range with power levels ranging up to
500 mW; Harmonised Standard cover-
ETSI EN 303 213-6-1 V2.1.1 13.1.2017 Article 3(2)

Advanced Surface Movement Guidance
and Control System (A-SMGCS); Part 6:
the Directive 2014/53/EU for deployed
surface movement radar sensors; Sub-
part 1: X-band sensors using pulsed
signals and transmitting power up to
100 kW
ETSI EN 303 339 V1.1.1 11.11.2016 Article 3(2)

Broadband Direct Air-to-Ground Com-
munications; Equipment operating in
the 1 900 MHz to 1 920 MHz and
5 855 MHz to 5 875 MHz frequency
bands; Fixed pattern antennas; Harmo-
requirements of article 3.2 of Directive
2014/53/EU
(1) (2) (3) (4) (5) (6)
ETSI EN 303 340 V1.1.2 11.11.2016 Article 3(2)

Digital Terrestrial TV Broadcast Recei-
vers; Harmonised Standard covering the
ETSI EN 303 354 V1.1.1 12.5.2017 Article 3(2)

Amplifiers and active antennas for TV
broadcast reception in domestic pre-
mises; Harmonised Standard covering
of Directive 2014/53/EU
ETSI EN 303 372-1 V1.1.1 13.1.2017 Article 3(2)

(SES); Satellite broadcast reception
article 3.2 of the Directive 2014/53/
EU; Part 1: Outdoor unit receiving in
the 10,7 GHz to 12,75 GHz frequency
band
ETSI EN 303 372-2 V1.1.1 9.9.2016 Article 3(2)

(SES); Satellite broadcast reception
article 3.2 of the Directive 2014/53/
EU; Part 2: Indoor unit

Maritime mobile transmitters and re- cle 3(3)(g)
ceivers for use in the MF and HF bands;
essential requirements of articles 3.2
and 3.3(g) of Directive 2014/53/EU
ETSI EN 303 406 V1.1.1 12.4.2017 Article 3(2)

Short Range Devices (SRD); Social
Alarms Equipment operating in the
frequency range 25 MHz to
1 000 MHz; Harmonised Standard cov-
(1) (2) (3) (4) (5) (6)
ETSI EN 303 609 V12.5.1 13.1.2017 Article 3(2)

tions (GSM); GSM Repeaters; Harmo-
ETSI EN 303 978 V2.1.2 11.11.2016 Article 3(2)

(SES); Harmonised Standard for Earth
Stations on Mobile Platforms (ESOMP)
transmitting towards satellites in geos-
tationary orbit, operating in the
27,5 GHz to 30,0 GHz frequency bands
ETSI EN 303 979 V2.1.2 11.11.2016 Article 3(2)

(SES); Harmonised Standard for Earth
Stations on Mobile Platforms (ESOMP)
transmitting towards satellites in non-
geostationary orbit, operating in the
27,5 GHz to 29,1 GHz and 29,5 GHz
to 30,0 GHz frequency bands covering
ETSI EN 305 550-2 V1.2.1 8.6.2017 Article 3(2)

to be used in the 40 GHz to 246 GHz
frequency range; Part 2: Harmonized
EN covering the essential requirements
of article 3.2 of the R&TTE Directive

legislation.
NOTE:
— This list replaces all the previous lists published in the Official Journal of the European Union under Directive 1999/5/EC
and Directive 2014/53/EU. The European Commission ensures the updating of this list.
(3) OJ C 338, 27.9.2014, p. 31.

ISSN 1977-091X (electronic edition)
ISSN 1725-2423 (paper edition)
EN

Harmonised Standards

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Official Journal C 389

of the European Union

English edition Information and Notices 17 November 2017

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

EN (1) Text with EEA relevance.

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND

Commission communication in the framework of the implementation of Directive 2014/68/EU of the

(1) (2) (3) (4) (5)

CEN EN 3-8:2006 12.8.2016

CEN EN 19:2016 12.8.2016

CEN EN 267:2009+A1:2011 12.8.2016

(1) (2) (3) (4) (5)

CEN EN 334:2005+A1:2009 12.8.2016

CEN EN 593:2009+A1:2011 12.8.2016

CEN EN 676:2003+A2:2008 12.8.2016

CEN EN 764-4:2014 12.8.2016

CEN EN 764-5:2014 12.8.2016

CEN EN 764-7:2002 12.8.2016

CEN EN 1057:2006+A1:2010 12.8.2016

CEN EN 1092-1:2007+A1:2013 12.8.2016

CEN EN 1092-3:2003 12.8.2016

(1) (2) (3) (4) (5)

CEN EN 1092-4:2002 12.8.2016

CEN EN 1171:2015 12.8.2016

CEN EN 1252-2:2001 12.8.2016

CEN EN 1349:2009 12.8.2016

CEN EN 1515-4:2009 12.8.2016

CEN EN 1562:2012 12.8.2016

CEN EN 1563:2011 12.8.2016

CEN EN 1564:2011 12.8.2016

CEN EN 1591-1:2013 12.8.2016

CEN EN 1626:2008 12.8.2016

CEN EN 1653:1997 12.8.2016

EN 1653:1997/A1:2000 12.8.2016 Note 3

(1) (2) (3) (4) (5)

CEN EN 1759-3:2003 12.8.2016

CEN EN 1759-4:2003 12.8.2016

CEN EN 1797:2001 12.8.2016

CEN EN 1866-2:2014 12.8.2016

CEN EN 1866-3:2013 12.8.2016

CEN EN 1983:2013 12.8.2016

CEN EN 1984:2010 12.8.2016

CEN EN ISO 4126-1:2013 12.8.2016

CEN EN ISO 4126-3:2006 12.8.2016

CEN EN ISO 4126-4:2013 12.8.2016

(1) (2) (3) (4) (5)

CEN EN ISO 4126-5:2013 12.8.2016

CEN EN ISO 4126-7:2013 12.8.2016

CEN EN ISO 9606-2:2004 12.8.2016

CEN EN ISO 9606-3:1999 12.8.2016

CEN EN ISO 9606-4:1999 12.8.2016

CEN EN ISO 9606-5:2000 12.8.2016

CEN EN ISO 9712:2012 12.8.2016

CEN EN 10028-1:2007+A1:2009 12.8.2016

CEN EN 10028-2:2009 12.8.2016

CEN EN 10028-3:2009 12.8.2016

CEN EN 10028-4:2009 12.8.2016

(1) (2) (3) (4) (5)

CEN EN 10028-5:2009 12.8.2016

CEN EN 10028-6:2009 12.8.2016

CEN EN 10204:2004 12.8.2016

CEN EN 10213:2007+A1:2016 12.8.2016

CEN EN 10216-1:2013 12.8.2016