1. 0343 Conformity assessment by: ing. H. Verschuren Lloyd’s Register Netherlands

2. 0343 Content Questions and Guidelines Hazard Analysis Essential Safety Requirements Instructions for use Hazard analysis, example Proposed changes to new approach

3. 0343 Guidelines Approved by: CABF WPG WGP

4. 0343 Guidelines 1.Scope and Exclusions 2.Classification and Categories 3.Assemblies 4.Evaluation Assessment 5.ESRs on Design 1/31/47 2/82/29 3/11 4/10 5/6

5. 0343 Guidelines 6.ESRs on Manufacturing 7.ESRs on Material 8.Other ESRs 9.Miscellaneous 10.Horizontal Issues 10/2 9/22 8/16 7/6 6/7

6. 0343 Content Questions and Guidelines Hazard Analysis Essential Safety Requirements Instructions for use Hazard analysis, example Proposed changes to new approach

7. 0343 Manufacturer Responsibilities ensure design and manufacturing to ESR’s ensure conformity assessment with ESR’s

8. 0343 Manufacturer Hazard Analysis. Consider all applicable hazards. Known and foreseeable, use and foreseeable misuse. Take into account all ESR’s if applicable. Instructions for use, containing all safety information.

9. 0343 Hazard Analysis Method EN 1050 elimination reduction warning

10. 0343 Essential Safety Requirements From cat I to IV obliged manufacturer has to provide a description of solutions adopted to meet the ESR’s. If non-harmonised standards are used.

11. 0343 Instructions for use Pressure equipment should be accompanied by instructions for use. Contain information relating to: mounting / assembling putting into service use maintenance

12. 0343 Instructions for use Content All info as mentioned in ann I §3.3 “Marking and labelling” All other relevant safety info All hazards not prevented by design or protective measures

13. 0343 Hazard Analysis example Evaluation of all appl hazards Description of solutions adopted to meet ESR’s (harm standards not used) Determining content for instructions for use

14. 0343 Hazard Analysis example Type of hazard 2.2 design for adequate strength 2.2.1 Internal pressure

15. 0343 NoType of hazard Rele- vant Y / N Risk estimation by Description of hazard 1 Internal pressure -normal operating conditions -regeneration conditions -thermal liquid expansion -exothermal reactions/run away YNNNYNNN MMMMMMMM 2 External pressure -vacuum -normal operating conditions -regeneration conditions -condensing steam/vapour due to cooling down

16. 0343 Description of hazardRisk No. Action Required Y / N Inlet from V1504, heating from steam jacket

17. 0343 Determining the risk number Rn Probability Effect Frequenty low (unlikely) moderate (likely) high (very likely) Light (First aid) seldom (1 < year) 1610141822 regularly (daily / weekly) 111620242832 serious (hospita l treatm ent) seldom (1 < year) 212630343842 regularly (daily / weekly) 313640444852 Severe (death) seldom (1 < year) 414650545862 regularly (daily / weekly) 515660646872 possible (almost) impossi ble possible (almost) impossi ble possible (almost) impossi ble Possibility of avoidance

18. 0343 Description of hazardRisk No. Action Required Y / N Inlet from V1504, heating from steam jacket 72

19. 0343 Interpretation Risk number risk nodescription recommended precaution 1 - 14very lownot necessary 15 - 26lowsimple precaution 27 - 36moderaterecommended 37 - 51high strongly recommended 52 - 72unacceptableobliged

20. 0343 Description of hazardRisk No. Action Required Y / N Inlet from V1504, heating from steam jacket 72Y

21. 0343 If applicable: risk reduction by DesignUse 3) ConstructionReductionAdditional precautions Warning EN 13445-3NA Y

22. 0343 4) Explications Action number 1Design 2Warning

23. 0343 1) Type of action Description 1DDesign for internal pressure of 12 bar according to EN13445-3 2WMax allowable pressure 12 bar.

24. 0343 Content Questions and Guidelines Hazard Analysis Essential Safety Requirements Instructions for use Hazard analysis, example Proposed changes to new approach

25. 0343 New module system ISO 9001:2000 Option 1 –One standard, One QA system, one module –H, B+H, B1+H, B2+H

26. 0343 Conformity asssessment procedures A G H DF Nobo/ UI Nobo Nobo/UI Manuf Design = QA System Certifications Final asses E1 Nobo AA1 Nobo/ UI Nobo/ UI E Nobo/ UI Nobo D1 H1 III III IV III Typeond. B1 O ntwp Ond. IV III IV Nobo III Nobo/ UI C1 B + + Nobo +

27. 0343 Conformity asssessment procedures G H F Nobo/UI Manuf Design = QA System Certifications Final asses Nobo/ UI Nobo/ UI Nobo/ UI Nobo Type B1 Nobo Nobo/ UI C B Nobo B2 Nobo A DesignTech doc

28. 0343 New module system ISO 9001:2000 Option 2 –One standard, three QA systems, three modules –D, E, H

29. 0343 New module system Category of equipment Clarity of QA system (cat of equipment) –B+E (3) B+D(4) both B+H

30. 0343 Lloyds Register Netherlands 0343