RISK MANAGEMENT REPORT NO.

RM-(PROJECT #)-00X
Sheet 1 of 18

Written By:

REV.

Reviewed By:

ECN History ECN

Date

APPROVALS

NAME

FUNCTION

APPROVAL

SIGNATURE

DATE

Director of Engineering

Operations Manager

Project Engineer

PRODUCTS:

Product Name

Model No.

Engineering No.

RISK MANAGEMENT REPORT NO.

RM-(PROJECT #)-00X
Sheet 2 of 18

Table of Contents
TABLE-E.1 ENERGY HAZARDS E-1 .....................................................................................................................................................4
ELECTROMAGNETIC ENERGY ...................................................................................................................................................................4
RADIATION ENERGY .....................................................................................................................................................................................4
MECHANICAL ENERGY ................................................................................................................................................................................4
TABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDS E-1 ..............................................................................................................5
BIOLOGICAL ...................................................................................................................................................................................................5
CHEMICAL ...........................................................................................................................................................................................................5
BIOCOMPATABILITY .........................................................................................................................................................................................................6
TABLE-E.1 OPERATIONAL HAZARDS E-1 ..........................................................................................................................................6
FUNCTION ...................................................................................................................................................................................................................6
USE ERROR ..........................................................................................................................................................................................................7
TABLE-E.1 INFOMATION HAZARDS E-1.................................................................................................................................................................7
LABELING ....................................................................................................................................................................................................................7
OPERATATING INSTRUCTIONS ...............................................................................................................................................................8
WARNINGS ...................................................................................................................................................................................................................8
TABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCES E-2 ...............................................................................................9
INCOMPLETE REQUIREMENTS:..........................................................................................................................................................................9
MANUFACTURING PROCESSES ......................................................................................................................................................................9
TRANSPORT AND STORAGE ......................................................................................................................................................................10
ENVIROMANTAL FACTORS ...........................................................................................................................................................................10
CLEANING, DISENFECTING, AND STERIALIZATION................................................................................................................................................10
DISPOSAL AND SCRAPPING .....................................................................................................................................................................11
FORMULATION .................................................................................................................................................................................................11
HUMAN FACTORS ............................................................................................................................................................................................12
FAILURE MODES ..............................................................................................................................................................................................13
Conclusion:.......................................................................................................................................................................................................................14
To be completed per instructions SOP-XX-XXRisk Management, current revision, in conjunction with standard ISO 14971 and MDD 93/42/EEC
ISO 14971 MDD 93/42/EEC

Note: ALL Boxes in matrix must have an entry whether applicable or not. ,
(Use N/A for boxes which are not applicable, The ACTION TAKEN Box must be filled out for an explanation Why it is not Applicable)
N/A

RISK MANAGEMENT REPORT NO.

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Sheet 3 of 18

PROBABILITY OF
OCCURRENCE

FREQUENT

PROBABLE

OCCASIONAL

REMOTE

IMPROBABLE

SEVERITY

CATASTROPHIC

CRITICAL

SERIOUS

MINOR

NEGLIGIBLE

PROBABILITY
RANGE

10-3
< 10-3 and 10-4
< 10-4 and 10-5
< 10-5 and 10-6
< 10-6

DESCRIPTION

OCCURRING OFTEN OR REPEATEDLY

REASONABLY LIKELY TO OCCUR

IRREGULAR OCCURRENCE, INFREQUENT

NOT LIKELY TO OCCUR

UNLIKELY TO EVER OCCUR

DESCRIPTION

RESULTS IN PATIENT DEATH

RESULTS IN PERMANENT IMPAIRMENT OR LIFE-THREATENING

INJURY

RESULTS IN INJURY OR IMPAIRMENT REQUIRING

PROFESSIONAL MEDICAL INTERVENTION

LOW RISK FAILURE NOT EXPECTED TO CONTRIBUTE TO AN

INJURY

INSIGNIFICANT FAILURE NOT SERIOUS ENOUGH TO

CONTRIBUTE TO AN INJURY

RISK MANAGEMENT REPORT NO.

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Sheet 4 of 18

PROBABILITY OF
OCCURRENCE

FREQUENT

PROBABLE

OCCASIONAL

REMOTE

IMPROBABLE

SEVERITY CATEGORIES

NEGLIGIBLE

MINOR

SERIOUS

CRITICAL

CATASTROPHIC

14

16

18

12

19

15

13

11

20

17

15

13

10

HAZARD RISK INDEX

1 TO 5
6 TO 9
10 TO 16

17 TO 20

ACCEPTANCE CRITERIA

UNACCEPTABLE

UNDESIRABLE. WRITTEN & REVIEWED DECISION TO PROCEED

ACCEPTABLE UPON COMPLETION OF QUALITY

ASSURANCE/REGULATORY REVIEW

ACCEPTABLE WITHOUT REVIEW

RISK MANAGEMENT REPORT NO.

RM-(PROJECT #)-00X
Sheet 5 of 18

Examples of hazards, foreseeable sequences of events and hazardous situations [from EN ISO 14971:2007 Annex E]
,
TABLE-E.1 ENERGY HAZARDS
ELECTROMAGNETIC ENERGY
HAZARD

Line Voltage

Enclosure
Leakage current

Earth Leakage
current

Patient Leakage
current

Electric Fields

Magnetic Fields

APPLICABLE

Ionizing
radiation

Non-ionizing
radiation

EFFECTS OF
FAILURE

RESPONSE

Design

Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No
Yes
No

Design
Label
Design
Label

APPLICABLE

RISK
INDEX

ACTION TAKEN

RISK
INDEX

ACTION TAKEN

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

MECHANICAL ENERGY
APPLICABLE POTENTIAL

HAZARD

CAUSE OF
FAILURE

Yes
No

RADIATION ENERGY
HAZARD

POTENTIAL
FAILURE

CAUSE OF

EFFECTS OF

RESPONSE

RISK

ACTION TAKEN

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Sheet 6 of 18

FAILUR
Gravity - Falling
-
Gravity
suspended
masses

Vibration

Stored Energy

Moving Parts

Torsion, shear
and tensile force
Moving and
positioning of
patient

Acoustic energy ultrasonic energy

-

Acoustic energy infrasound

energy

Acoustic energy sound

High pressure
fluid injection

FAILURE

Bacteria

INDEX
Design
Label

Yes
No

Design
Label

Yes
No
Yes
No
Yes
No
Yes
No

Design
Label
Design
Label
Design
Label
Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

TABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDS

BIOLOGICAL

HAZARD

FAILURE

Yes
No

APPLICABLE
Yes
No

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE
Design
Label

RISK
INDEX

ACTION TAKEN

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Sheet 7 of 18

Viruses

Other agents (e.g.

prions)

Re- or crossinfection

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

CHEMICAL: Exposure of airway, tissues, environment or property e.g. to foreign materials

POTENTIAL
CAUSE OF
EFFECTS OF
RISK
RESPONSE
HAZARD
ACTION TAKEN
APPLICABLE FAILURE
FAILURE
FAILURE
INDEX
Acids or alkalis

Residues

Contaminants

Addictives or
processing aids

Cleaning,
disinfecting or
testing agents

Degradation
products

Medical gasses

Anesthetic
products

Yes
No
Yes
No
Yes
No

Design
Label
Design
Label
Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

BIOCOMPATABILITY, Toxicity of chemical constituents, e.g.

HAZARD
Allergenicity/
irritancy

APPLICABLE
Yes
No

POTENTIAL
FAILURE

CAUSE OF
FAILURE

RESPONSE

EFFECTS OF
FAILURE

Design
Label

RISK
INDEX

ACTION TAKEN

RISK MANAGEMENT REPORT NO.

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Sheet 8 of 18

/
Pyrogenicity
(induce fever)
(
)

Yes
No

Design
Label

TABLE-E.1 OPERATIONAL HAZARDS

FUNCTION
HAZARD
Incorrect or
inappropriate
output or
functionality

Incorrect
measurement

Erroneous data
transfer

Loss or
deterioration of
function

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK
INDEX

ACTION TAKEN

RISK
INDEX

ACTION TAKEN

USE ERROR
HAZARD
Attentional
failure

Memory failure

Rule-based
failure

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No
Yes
No

Design
Label
Design
Label

RISK MANAGEMENT REPORT NO.

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Knowledgebased failure

Routine
Violation

Yes
No

Design
Label

Yes
No

Design
Label

TABLE-E.1 INFOMATION HAZARDS

LABELING
HAZARD
Incomplete
instructions for
use

Inadequate
description of
performance
characteristics

Inadequate
specification of
accessories to be
used with the
medical device

Inadequate
disclosure of
limitations

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK
INDEX

ACTION TAKEN

RISK MANAGEMENT REPORT NO.

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Sheet 10 of 18

OPERATATING INSTRUCTIONS
HAZARD
Inadequate
specification of
accessories to be
used with the
medical device

Inadequate
specification of
pre-use checks

Overcomplicated
operating
instructions

WARNINGS
HAZARD
Warnings of side
effects

Warnings of
hazards likely
with re-use of
single-use
medical devices

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK
INDEX

ACTION TAKEN

RISK
INDEX

ACTION TAKEN

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

RISK MANAGEMENT REPORT NO.

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Sheet 11 of 18

SPECIFICATION OF SERVICE AND MAINTENANCE

HAZARD
Inadequate
specification of
when service and
maintenance is
required

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

Yes
No

RESPONSE

RISK
INDEX

Design
Label

EFFECTS OF
RISK
RESPONSE
ACTION TAKEN

TABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCES

INCOMPLETE REQUIREMENTS, Inadequate Specification of:
HAZARD
Design
parameters

Operating
parameters

Performance
requirements

In-service
requirements
(e.g.
maintenance,

APPLICABLE

ACTION TAKEN

POTENTIAL
FAILURE

CAUSE OF
FAILURE

FAILURE

INDEX

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK MANAGEMENT REPORT NO.

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Sheet 12 of 18

reprocessing)

End of life

Yes
No

Design
Label

MANUFACTURING PROCESSES, Insufficient control of: :

POTENTIAL
CAUSE OF
EFFECTS OF
RISK
RESPONSE
HAZARD
APPLICABLE FAILURE
FAILURE
FAILURE
INDEX
Changes to
manufacturing
process

Materials /
materials
compatibility
information

Manufacturing
processes

Subcontractors

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

TRANSPORT AND STORAGE

HAZARD
Inadequate
packaging

Contamination or
deterioration

Inappropriate
environmental
conditions

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

ENVIROMANTAL FACTORS

CAUSE OF
HAZARD
APPLICABLE POTENTIAL
FAILURE
FAILURE
Physical (e.g.

Yes

ACTION TAKEN

EFFECTS OF
FAILURE

RESPONSE
Design

RISK
INDEX

RISK
INDEX

ACTION TAKEN

ACTION TAKEN

RISK MANAGEMENT REPORT NO.

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Sheet 13 of 18

heat, pressure,
time)

Chemical (e.g.
cocorrosions,
degradation,
contamination)

Electromagnetic
fields (e.g.
susceptibility to
electromagnetic
disturbance)

Inadequate
supply of power

Inadequate
supply of coolant

No

Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

CLEANING, DISENFECTING, AND STERIALIZATION

HAZARD
Lack of, or
inadequate
specification for,
validated
procedures for
cleaning,
disinfecting and
sterilization.

APPLICABLE

Yes
No

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Design
Label

RISK
INDEX

ACTION TAKEN

RISK MANAGEMENT REPORT NO.

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Sheet 14 of 18

Inadequate
conduct for
cleaning,
disinfecting and
sterilization

Yes
No

Design
Label

DISPOSAL AND SCRAPPING

HAZARD

APPLICABLE

No, or
inadequate
information
provided.

Use error

Biodegration
Biocompatibility

No Information
or inadequate
specification
provided

Inadequate
warnings of
hazards
associated with
incorrect
formulations

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

RISK
INDEX

ACTION TAKEN

RISK
INDEX

ACTION TAKEN

FORMULATION
HAZARD

POTENTIAL
FAILURE

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No
Yes
No

Design
Label
Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK MANAGEMENT REPORT NO.

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Sheet 15 of 18

Use error

Yes
No

Design
Label

HUMAN FACTORS, Potential for use errors triggered by design flaws, such as:
POTENTIAL
CAUSE OF
EFFECTS OF
RISK
RESPONSE
ACTION TAKEN
HAZARD
APPLICABLE FAILURE
FAILURE
FAILURE
INDEX
Confusing or
missing
instructions for
use

Complex or
confusing control
system

Ambiguous or
unclear device
state

Ambiguous or
unclear
presentation of
settings,
measurements or
other information

Misrepresentation
of results

Insufficient
visibility,
audibility of
tactility

Poor mapping of
controls to

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

RISK MANAGEMENT REPORT NO.

RM-(PROJECT #)-00X
Sheet 16 of 18

actions, or of
displayed
information to
actual state

Controversial
modes or
mapping as
compared to
existing
equipment

Use by
unskilled/untrain
ed personnel

Insufficient
warnings of side
effects

Inadequate
warnings of
hazards
associated with
re-use of singleuse medical
devices

Incorrect
measurement and
other
metrological
aspects.

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No

Yes
No

Design
Label

Design
Label

RISK MANAGEMENT REPORT NO.

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Sheet 17 of 18

Incompatibility
with
consumables/acc
essories/other
medical devices

Slip, laps and

mistakes

Yes
No

Design
Label

Yes
No

Design
Label

FAILURE MODES
HAZARD
Unexpected loss
of
electrical/mechan
ical integrity

Deterioration in
function (e.g.
gradual occlusion
of fluid/gas
path, or change
in resistance
to flow, electrical
conductivity) as
a result of
ageing, wear and
repeated use

Fatigue failure

Inadequate
warnings of
hazards

APPLICABLE

POTENTIAL
FAILURE

CAUSE OF
FAILURE

EFFECTS OF
FAILURE

RESPONSE

Yes
No

Design
Label

Yes
No

Design
Label

Yes
No
Yes
No

Design
Label
Design
Label

RISK
INDEX

ACTION TAKEN

RISK MANAGEMENT REPORT NO.

RM-(PROJECT #)-00X
Sheet 18 of 18

associated with
incorrect
formulations

Use error

Yes
No

Design
Label

Conclusion:
It has been concluded through the process of risk analysis that this is a low risk device and any risks that existed were eliminated or reduced
through safety testing, proper choice of materials, sterilization validation, and thorough instructions for use. The risk analysis was evaluated in
regarding the European Medical Device Directives (MDD), Annex 1, Chapter 1, point 1 and 2.