1. ESS approach and support for Declaration of Conformity (CE-marking) Fredrik Håkansson 9th SRF ESS

2. Agenda ESS Approach – step by step to compliance
Delivery definitions and compliance approach
System compliance, step-by-step with ESS support
Applicable Directives & Standards & National Legislation
Cryomodules
Cavities
Next step

3. Approach – step by step to compliance
Delivery definitions and compliance approach
The contribution scope defines the compliance approach. An in-kind contribution can either be:
A “Full system delivery”, e.g. Spoke & Elliptical Cryomodules – where the in-kind partner is defined as the “Manufacturer”.
In this case the in-kind partner is responsible to conform to applicable directive(s) and sign a “Declaration of Conformity*”. Or
A “Partly completed machinery”, component etc. that will be assembled into a system. E.g. elliptical cavities.
In this case the in-kind partner is still responsible that its contribution conforms to applicable directive(s) via a “Declaration of conformity” or a simplified “EU declaration of incorporation”, “Signature Card” or similar.
*Keep in mind that there are no “difference” between a DoC and CE-marking in the case of the Cryomodules but for the Cavities it is.

4. Agenda ESS Approach – step by step to compliance
Delivery definitions and compliance approach
System compliance, step-by-step with ESS support
Applicable Directives & Standards & National Legislation
Cryomodules
Cavities
Next step

5. Approach – step by step to compliance
System compliance, step-by-step with ESS support
Procedure in cooperation and support by ESS (unless the in-kind partner want to proceed and do the Declaration of Conformity by own process). Learnings has been made from the Ion-source & LEBT work.
Identify the scope (system with interfaces) and its applicable directive(s), regulations and standards.
ESS WP and regulatory expertise can support with this action. The result is documented in the “Technical file document” and the “Declaration of Conformity”
This is done for WP4-5 but yet to be reviewed and documented in the Technical File.

6. Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
“Pre-inspection” comparing current system/component status to identified directives, regulations and standard requirements.
The directives contain “essential safety requirements”, to be fulfilled for achieving compliance.
ESS regulatory expertise can check the system and documentation (1 day exercise) and identify possible “gaps”, to be mitigated.
Defined actions will then be carried out by the in-kind partner, with ESS support upon need.
Prepared to be executed on the Spoke prototype incl. docs in Uppsala in November.

7. Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
Compile technical documentation (“technical file”)
The technical file contains all documentation needed for the DoC.
ESS can explain/guide about the needed content (should be nothing or marginally new to what is already agreed in the Technical Annex) incl. template/example.
ESS can further support the Technical File by reviewing documents and answering regulatory questions.

8. Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
Technical file – example from the Ion-source & LEBT

9. Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
Technical file – example from the Ion-source & LEBT

10. Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
Technical file content – as written in the Machinery Directive
The technical file shall comprise the following:
— a general description of the machinery,
— the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent
descriptions and explanations necessary for understanding the operation of the machinery,
— full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to
check the conformity of the machinery with the essential health and safety requirements,
— the documentation on risk assessment demonstrating the procedure followed, including:
(i) a list of the essential health and safety requirements which apply to the machinery,
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce
risks and, when appropriate, the indication of the residual risks associated with the machinery,
— the standards and other technical specifications used, indicating the essential health and safety requirements
covered by these standards,
— any technical report giving the results of the tests carried out either by the manufacturer or by a body
chosen by the manufacturer or his authorized representative,
— a copy of the instructions (manual) for the machinery,
— where appropriate, the declaration of incorporation for included partly completed machinery and the
relevant assembly instructions for such machinery,
— where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated
into the machinery,
— a copy of the EC declaration of conformity;
(— In addition: a) Reference to the project quality plan tracking that all specimen are built a like b) PMA, “particular material appraisals” regarding Niobium)

11. Approach – step by step to compliance
´Full system compliance, step-by-step with ESS support
Produce Declaration of Conformity and CE-mark
When the pre-inspection actions are mitigated and the technical file is accomplished the “Declaration of Conformity” can be signed by the in-kind partner´s “responsible person” (someone who has the power to make binding commitments on behalf of the manufacturer). ESS can provide a template of the Declaration if wanted.
The Declaration should preferably be accomplished before commissioning, to assure that the equipment is safe.
When the Declaration is signed, the CE-mark (Incl. marking, template can be provided by ESS) can be affixed on the equipment.

12. Done – with Declaration of Conformity!
Approach – step by step to compliance
Full system compliance, step-by-step with ESS support
Done – with Declaration of Conformity!

13. Agenda ESS Approach – step by step to compliance
Delivery definitions and compliance approach
System compliance, step-by-step with ESS support
Applicable Directives & Standards & National legislation
Cryomodules
Cavities
Next step

14. Applicable Directives & Standards
Cryomodules
Swedish Legislation*
SFS 2017:218 Elsäkerhetsförordning (Swedish Electrical Safety Ordinance)
ELSÄK-FS 2008:1 (Design for electrical installation)
*A part from CE-legislation, national legislation has to be fulfilled. Implemented through inspection process with action on possible deviations.
CE Directives
Machinery Directive 2006/42/EC
(Low Voltage Directive LVD 2014/35/EU – included in the MD)
Electromagnetic Compatibility Directive 2014/30/EU
For fixed installations, hence simplified to “good engineering practice”.
Pressure Equipment Directive 2014/68/EU
SEP (Art 4.3) is applicable
EU Regulations
CLP Regulation/1272/ Marking of pipes & vessels

15. Primary Recommended Standards*
Applicable Directives & Standards
Cryomodules
Primary Recommended Standards*
MD: IEC Safety of Machinery – Electrical equipment of Machines
EN ISO :2017, Cryogenic vessels – Materials – Part 1: Toughness requirements for temperatures below –80 °C.
PED Manufacturing, Welding & Testing
PED Vessels & Accessories
EN Specification and qualification of welding procedures for metallic materials.
EN &2 Cryogenic vessels - Static vacuum insulated vessels. Part1 Fundamental requirements. Part 2: Design, fabrication, inspection and testing.
EN ISO 9606; Qualification test of welders – Fusion Welding (part depending on material)
EN Cryogenic vessels – Pressure relief accessories for cryogenic service.
EN ISO 9712, Qualification and certification of NDT personnel.
EN 1626:2008 Cryogenic vessels – Valves for cryogenic service
EN 5817 Fusion-welded joints in steel, nickel, titanium and their alloys.
EN 1797 Cryogenic vessels – Gas/material compatibility.
EN Cryogenic vessels, cleanliness for cryogenic service.
EN Unfired pressure vessels, part rules for the design, fabrication, and inspection of pressure vessels.
PED Material
*Used to facilitate (not mandatory) compliance with the applicable directives. Blue book: “Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements”.

16. Agenda ESS Approach – step by step to compliance
Delivery definitions and compliance approach
System compliance, step-by-step with ESS support
Applicable Directives & Standards & National legislation
Cryomodules
Cavities
Next step

17. Primary Recommended Standards
Applicable Directives & Standards
Cavities
EN &2 Cryogenic vessels - Static vacuum insulated vessels. Part1 Fundamental requirements. Part 2: Design, fabrication, inspection and testing.
CE Directives
EN Specification and qualification of welding procedures for metallic materials.
Pressure Equipment Directive 2014/68/EU
SEP (Art 4.3) applicable and hence no CE-marking only a DoC.
EN Cryogenic vessels – Pressure relief accessories for cryogenic service.
EN ISO 9606; Qualification test of welders – Fusion Welding (part depending on material)
EN 1626:2008 Cryogenic vessels – Valves for cryogenic service
EN ISO 9712, Qualification and certification of NDT personnel.
EU Regulations
CLP Regulation/1272/ Marking of pipes & vessels
EN 1797 Cryogenic vessels – Gas/material compatibility.
EN 5817 Fusion-welded joints in steel, nickel, titanium and their alloys.
EN Unfired pressure vessels, part rules for the design, fabrication, and inspection of pressure vessels.
EN Cryogenic vessels, cleanliness for cryogenic service.
Swedish Legislation NA
PED Material
Primary Recommended Standards
EN :2017, Cryogenic vessels – Materials – Part 1: Toughness requirements for temperatures below –80 °C.
EMC: IEC ; Electromagnetic compatibility (Immunity & Emission)
PED Manufacturing, Welding & Testing
PED Vessels & Accessories

18. Agenda ESS Approach – step by step to compliance
Delivery definitions and compliance approach
System compliance, step-by-step with ESS support
Applicable Directives & Standards & National legislation
Cryomodules
Cavities
Next step

19. Next step To progress according to set process:
In-kind review of identified Directives & Standards.
Establish “Technical File”.
Pre-inspection of available prototypes incl. documentation resulting in a deviation/action-list for compliance.
DoC (appoint responsible person) and CE-marking.

20. Next step ESS Support Team:
Mattias Skafar Conny Wendt Fredrik Håkansson Larry Falk Maurice Looft
Head of Quality Division Quality CE-Lead AD CE Responsible CE Expert CE Expert

21. Thank You! Questions?