BS EN ISO 11607-2:2020+A11:2022

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Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes

Published By	Publication Date	Number of Pages
BSI	2022	32

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Categories: 11.080.30 - Sterilized packaging, BSI

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Description

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PDF Pages	PDF Title
2	National foreword
6	European foreword Anchor 5 European foreword to amendment A11
8	Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be covered
11	Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] (as amended) aimed to be covered
13	Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
16	Foreword
17	Introduction
19	1 Scope 2 Normative references 3 Terms and definitions
23	4 General requirements 4.1 Quality systems
24	4.2 Risk management 4.3 Sampling 4.4 Test methods 4.5 Documentation
25	5 Validation of packaging processes 5.1 General 5.2 Installation qualification
26	5.3 Operational qualification
27	5.4 Performance qualification 5.5 Formal approval of the process validation
28	5.6 Process control and monitoring 5.7 Process changes and revalidation 6 Assembly
29	7 Use of reusable sterile barrier systems 8 Sterile fluid-path packaging
30	Annex A (informative) Process development
31	Bibliography

Additional information

Publication Date	2022-09-13
Amends	BS EN ISO 11607-2:2020
Modified National Standard Of	ISO 11607-2:2019
Descriptors	Packages, Packaging materials, Quality, Verification, Seals, Sterilization (hygiene), Sterile equipment, Packaging, Wrapping, Packaging processes, Medical equipment, Sealing processes, Medical instruments, Performance, Performance testing, Quality assurance systems, Acceptance (approval)
Identical National Standard Of	EN ISO 11607-2:2020/A11:2022
Standard Number	BS EN ISO 11607-2:2020+A11:2022
ISBN	978 0 539 23169 4
Withdrawn Date	2023-11-01
Pages	32
Committee	CH/198
Publisher	BSI
Replaces	BS EN ISO 11607-2:2017
Title	Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes
Status	Withdrawn
ICS Codes	11.080.30 - Sterilized packaging

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BS EN ISO 11607-2:2020+A11:2022

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