1 Introduction

According to PED an assembly has to be assessed following the global conformity assessment procedure (GC). The GC is not explained in detail in the PED. This guidance document aims to give some more insight in how to assess the conformity of assemblies by notified bodies. The scope of this document is limited to the direct inspection route modules (such as A1, B, C1, F, G), not the QA modules (D, E and H).

2 Objective
The objective of this document is to establish consistency in application of the global conformity assessment procedure by CABs as mentioned in article 10.2 of the PED. This is achieved by giving guidance in the main steps to the conformity assessment of assemblies. Furthermore guidance and explanations is given to a number of guidelines that need clarification. This document is intended to be a public document and available to all parties involved.

3 Definitions
Article 1 paragraph 2.1.5 defines assemblies as an integrated, functional whole. This paragraph gives some notes on this definition. As there are no upper or lower limits for an assembly, it could vary from a fire extinguisher to an oil refinery. As there are no such limits a global conformity assessment can vary form small to very large. It is therefore advisable that the manufacturer (in many cases in close communication with the user) determines the limits as early as possible. This is important to clarify the scope of work for de CAB and can be of influence on the inservice inspections under national law. It is the manufacturer who is responsible for determining the limits of the assembly. It is advisable to keep the functional unit as small as practical. For example a large and complex assembly could be divided in smaller sub-assemblies which assessed one by one and joined together later.

4 Documentation
The manufacturer must provide (depending on the conformity assessment procedure) the following technical documentation for the assessment, this list is not exhaustive.

At the design assessment stage: General description of the assembly (including intended use and foreseen misuse). List of equipment with all relevant information (PS, TS, content, fluid, category, etc). for examples see appendix 1 and 2 Instructions for use of each item of pressure equipment (specifically the safety related information such as; pressure, temperature, fluids, safeguarding etc) Hazard analyses of the assembly (cases such as fire, coolant system, power failure, etc) Information relating to safeguarding (eg flow sheets, safety valve capacity, maximum flow of fluid, ) Process flow diagram, Piping & Instrumentation diagram Standards by which the integration and safeguarding is designed and constructed. Examples of possible standards used:
o o o o o o o o o ANSI/API Standard 521 (of ISO 23251) API Standard 520 EN ISO 4126-1/3/4/5 EN 764-7 ISO/IEC 61511-1/2/3 EN 12952-10 EN 12953-8 EN 378 A harmonised standard for intergration and safeguarding of other assemblies should be developed.

At the stage of manufacturing or final assessment: DOC of all pressure equipment making up the assembly (and which have been subjected to a conformity assessment procedure). DOC of all other equipment that is essential for the safety of the assembly, and which is covered by a directive. (ie CSPRS, SRMCR) As built documentation (must be available at the inspection stage) DOC of the assembly (draft) Instructions for use of the assembly (draft)

5 Global conformity assessment

All ESRs are to be taken into account in the hazard analysis of an assembly, when applicable. The global conformity assessment comprises of three stages as stated in article 10.2 (a, b and c).

5.1 Assessment of each equipment

art 10.2 a

There is no need (it is even prohibited) to re-assess equipment that has already been CE-marked. The proper documentation (instructions for use, Declaration of conformity) need to be available. The CAB should check the DOCs and identify the equipment that has not been assessed yet. Art 15.3 states that the physical CE-marking is not necessary for every item in the assembly, but the applicable conformity assessment procedure must be performed for every item of pressure equipment in the assembly.

5.2 Assessment of integration of components of assembly art 10.2b

Although the article refers to specifically to ESRs 2.3, 2.8 and 2.9 of annex 1, the manufacturer must take into account all applicable ESRs (guideline 3-12).

5.2.1 design
Items to be assessed during the design appraisal of integration (this list is not exhaustive) (assessment depending on the chosen module): General info, equipment and line list, hazards analysis, process description (from a safety point of view, for understanding the use of the assembly), user manuals etc. for examples of lists see appendix 1 and 2 Verification according to the P&ID. On the P&ID all fluid flows will be considered. Where does the fluid come from (pump, vessel, etc.) and what is the set pressure of safety devices or maximum pressure from the pump. Of all equipment it must be assessed if they are suitable for the intended use (PS, TS, fluid, vacuum, cold or hot flashing, forces on nozzles, vibration, fatigue, etc etc) Possibility of different fluids getting mixed, possible reactions (ESR 2.2.3) lines connected to a pump, pressure, vibrations, fatigue (ESR 6 d) flexibility of piping (ESR 6 a) cat II and higher (the flexibility of the piping has been considered during the conformity assessment of the piping. The forces on connecting equipment (nozzle loads) shall be considered during the assessment of the assembly) nozzle loads (ESR 2.2.1 +6 d) Static head of liquid.

One by one the possible malfunctions (related to pressure) shall be considered. One single malfunction should not lead to exceeding of the design limits of any equipment. Examples are: o Malfunction of cooling system o Rupture of one pipe in a heat exchanger o Closing or opening of one or more valves o Thermal expansion of liquid o Power failure / utilities / cooling. o Exothermal reaction o Fire o Foreseeable misuse o A pressure just under the set pressure of a safety device is considered as normal operations condition. o etc

5.2.2 inspection
Items to be inspected at the integration stage (this list is not exhaustive): welds / WQ / WPQR/ NDT (wpg 3/15) nozzle loads, vibrations and fatique (ESR 6 d) provisions to ensure safe handling and operation (ESR 2.3) means of examination (ESR 2.4) means of draining and venting (ESR 2.5 + 6 b) Provisions for filling and discharge (ESR 2.9) connections and supports (ESR 6 a) verification according the P&ID (ie position of valves, verification according the as build isometrics pressure testing of the assembly (guideline 3-6) see 8.2

5.3 Assessment of safeguarding

art 10.2c

If, as a result of the assessment of the integration and / or the hazard analysis, an assembly is to be equipped with protective devices, the assessment of the safe guarding must contain at least the following (this list is not exhaustive):

5.3.1 Design
Items to be assessed in the design stage of safe guarding: Acoustic alarm systems. safety accessories, type (ie bellow / foil), category, capacity, activation value (ie pressure, temperature) input signals for ESD valve Blow-off capacity calculation / liquid /gas? Blow-off lines of safety accessories. o Capacity / size,

o Back pressure (ie from resistance in the line, from general flare system) o Supports of the line, o Safe blow-off location SRMCR, CSPRS, design, SIL class,

5.3.2 Inspection
Items to be considered in the inspection stage: activation values, pressure, temperature, etc o test certificate of opening pressure of safety valve (not older than 12 months) o simulation test o actual in-situ test o certificates of other devices (such as rupture disks) type of safety device (ie material of RDs, bellow in PSVs) combination of safety devices such as RDs with PSV (pressure build-up between RD and PSV), Blow-off lines of safety accessories. o Size, o Supports of the line, o Safe-blow off location Verification if built according to design (P&ID) Location of other equipment verification of locked open / locked closed valves, testing of interlock systems (or comparable system) reference for level of safety EN 764 part 7 paragraph 8.5 data plate and CE-marking for the assembly.

6 Category and modules

The conformity assessment module of the integration is determined by the highest category in the assembly (not safety accessories). Article 10.2b The category for safeguarding assessment is determined by the protected equipment. Article 10.2c It is possible to determine a lower category for equipment according to guideline 3-16. This category can be used for integration and safeguarding assessment. See also the note of guideline 3-16 about CE marked equipment in an art 3.3 assembly.

7 Certificate of conformity
When the conformity assessment has been completed the CAB shall issue a document to the manufacturer. For modules B, B1, F and G this document shall be a certificate (see annex III), for modules A1 and C1 this document can be or any other report about the result of the visit (see CABF-R-013). It should be clearly stated that it concerns an assembly (as opposed to equipment) or a reference to article 10.2 a, b and c. Manufacturer. The CAB shall check the (draft of the) DOC from the manufacturer. It should be clear that it concerns an assembly (preferably stated as assembly, list of equipment, reference to art 10.2).

8 Specific topics and guidelines

8.1 Specific topics
Recital 5
Assembly on site under responsibility of the user. This is the case when a user buys several pieces of pressure equipment and has them assembled (under his responsibility) and put into service on his site for his own use. These systems should be covered by national legislation. Free choice of conformity assessment? Is there a difference regarding the obligation to perform the conformity assessment of an assembly acc to art 3.2.1 and an assembly acc. to art 3.2.2? No. Article 3.2.1 does not have the text "if the manufacturer intents to place it on the market and put it into service as assembly". Apparently this has been interpreted as if for this type of pressure equipment according article 3 2.2.1 it is possible to manufacture an assembly without the intention of placing it on the market and put it into service as assembly. This would mean that the manufacturer has the choice to perform conformity assessment or not. And in both cases would meet the requirement from PED. That is incorrect. If an assembly meets the definition of assembly it must meet the requirements of PED. This does not limit the possibility of delivering part of an assembly (a sub-assembly) according to guideline 3-10 the conformity assessment can be performed in a later stage. The choice of the manufacturer is not IF an assembly is being assessed, but WHEN.

8.2 Guidelines
Guideline 3-1 assembled by user.

No clarification needed Guideline 3-2 joining operations on site No clarification needed Guideline 3-3 SEP in manually fed boiler No clarification needed Guideline 3-4 minimum extend of boiler No clarification needed Guideline 3-5 CE-marking for assembly 3.2.3 No clarification needed

Clarification of guideline 3-6 (pressure testing of assembly)

All permanent joining in an assembly needs to be pressure tested. This is not required for non-permanent joints. Examples of non-permanent joints: flanges, screwed fitting, Guideline 3-7 conformity assessment of non CE-marked equipment in an assembly No clarification needed Guideline 3-8 definition of assembly No clarification needed Guideline 3-9 application and limits of an assembly No clarification needed Guideline 3-10 assemblies without CE-marking No clarification needed Guideline 3-11 equipment in assembly No clarification needed Guideline 3-12 ESRs in assembly No clarification needed Guideline 3-13 non PED equipment in an assembly No clarification needed Guideline 3-14 CE-marking of 3.2.3 assembly No clarification needed Guideline 3-15 category of permanent joining in an assembly No clarification needed Guideline 3-16 highest category

No clarification needed

Clarification of guideline 3-17 (assembly without safety device)

This guideline only applies when, from the hazard analysis, a safety accessory is required to protect the assembly from exceeding its allowable limits. An assembly does not always need to be safeguarded. If an assembly, which requires a safety accessory to protect it from exceeding its allowable limits, is delivered to the user without that safety accessory it can be either the manufacturer or the user who takes responsibility for the (completed) assembly. Can it be delivered to the end user without safety device? If the end user installs the safety device? In the first case it will be manufacturer (and his CAB, if applicable) who finishes the conformity assessment and affix CE marking. In the second case it is the user (and the national inspection body, if applicable) who is responsible for meeting the requirements under national legislation. Yes, but the conformity assessment can not be finished until the final setup has been confirmed (at the users premises).

Appendix 1. Draft table for integration and safeguarding of assemblies

Ref. to PED 2.1.1. Pressure vessel 2.1.2. Piping Pressure Equipment pressure vessel piping, Cu 35 x 1,5 piping, St 50 x 1 safety valve Manufacturer XYZ- GmbH ZZZ-GmbH ZZZ-GmbH ABC AG SerialNo. 123456 111222-1 111222-2 45678 Volume or Diameter (DN) 1000 L 32 mm 48 mm 40 mm max. Design Pressure (PS) 10 bar 20 bar 20 bar 11 bar max. Design Temp. (TS) 50 50 50 50 Fluid air air air air FluidGroup 2 2 2 2 Category IV art. 3, (3) I IV Applied Module G A B+D 0098 valve, inlet valve, outlet pressure regulator filter separator Pressure gauge AXYZ-GmbH AXYZ- GmbH AXYZ- GmbH ABAB GmbH ABAB GmbH DEFG AG 45677 45676 77777 77778 77779 123987 50 mm 32 mm 32 mm 8L 10 L 16 bar 16 bar 12 bar 20 bar 16 bar 16 bar 50 50 60 80 50 100 air air air air air Air 2 2 2 2 2 2 I art. 3, (3) I art. 3, (3) A Marking 0098 Certificate of Conformity No. GL 39 308 -08 HH

* B: 50 125 - 06 HH D: 39 309 - 08 HH -

2.1.3. Safety Accessories 2.1.4. Pressure Accessories

2.1.5. Assemblies supplemental information

Compressed Air Unit main drawing no. applicable design code

ZZZ-GmbH 1234567 rev.0 AD-2000

111222

10 bar

50C

air

IV

0098

GL 39 000 - 08 HH

TAG nr
2

Name
2a 2b 3

From (piping) To (piping) P&ID

Ref NBCAB
5

User reference
6

Chamber
7

ltr
7a 8 9

Volume DN (piping) Operating condition fluid

10 11

Mm

State of aggregation
C Kg/m3 bar bar C bar bar C C Y/N C bar bar C C

Appendix 2 Draft table for integration and safeguarding (classification and line list)

Atmospheric boiling point

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

Mass Vapour pressure at TS Operating pressure Operating temperature Min operating pressure Max operating pressure Min operating temperature Max operating temperature tracing Max temperature tracing Min allowable pressure in assembly Max allowable pressure in assembly Min allowable temperature in assembly Max allowable temperature in assembly Applied design code