BS EN ISO 11607-2:2020+A1:2023

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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	2023	42

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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	undefined
6	European foreword Anchor 5 European foreword to amendment A11
8	Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
14	Annex ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
19	Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
22	Foreword
23	Introduction
25	1 Scope 2 Normative references 3 Terms and definitions
29	4 General requirements 4.1 Quality systems
30	4.2 Risk management 4.3 Sampling 4.4 Test methods 4.5 Documentation
31	5 Validation of packaging processes 5.1 General 5.2 Installation qualification
32	5.3 Operational qualification
33	5.4 Performance qualification 5.5 Formal approval of the process validation
34	5.6 Process control and monitoring 5.7 Process changes and revalidation 6 Assembly
35	7 Use of reusable sterile barrier systems 8 Sterile fluid-path packaging
36	Annex A (informative) Process development
37	Annex sec_B Annex sec_B.1 Annex sec_B.2
38	Annex sec_B.3 Annex sec_B.3.1 Annex sec_B.3.2 Annex sec_B.4
39	Table tab_B.1 Annex sec_B.5 Annex sec_B.6 Annex sec_B.7
40	Annex sec_B.8
41	Bibliography

Additional information

Status	Definitive
Title	Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes
Replaces	BS EN ISO 11607-2:2017
Publisher	BSI
Committee	CH/198
Pages	42
Publication Date	2023-11-01
ISBN	978 0 539 14211 2
Standard Number	BS EN ISO 11607-2:2020+A1:2023
Identical National Standard Of	EN ISO 11607-2:2019/Amd 1, ISO 11607-2:2019/Amd 1
Descriptors	Packaging processes, Sterilization (hygiene), Quality assurance systems, Performance testing, Performance, Seals, Packaging materials, Medical equipment, Packaging, Sterile equipment, Acceptance (approval), Quality, Packages, Sealing processes, Medical instruments, Verification, Wrapping
Amends	BS EN ISO 11607-2:2020+A11:2022
ICS Codes	11.080.30 - Sterilized packaging

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BS EN ISO 11607-2:2020+A1:2023

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