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BS EN ISO 11607-1:2020+A1:2023

Current

Current

The latest, up-to-date edition.

Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

13-05-2026

€395.12
Excluding VAT
Summarise this standard

Committee
CH/198
DocumentType
Standard
Pages
86
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 11607-1:2020/A1:2023 Identical

Frequently Asked Questions

BS EN ISO 11607-1 belongs to the topic area of terminally sterilised medical device packaging. It is a standard listed for United Kingdom published by British Standards Institution (BSI).

BS EN ISO 11607-1 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. It is a standard listed for United Kingdom published by British Standards Institution (BSI).

BS EN ISO 11607-1 is British Standards Institution (BSI)'s standard for terminally sterilised medical device packaging, while BS EN ISO 11137-1 covers radiation sterilisation of healthcare products (United Kingdom). BS EN ISO 11607-1 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. BS EN ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

No — BS EN ISO 11607-1 is a standard listed for United Kingdom published by British Standards Institution (BSI), with its listed region as United Kingdom.

BS EN ISO 11607-1 is published by British Standards Institution (BSI). It is a standard listed for United Kingdom.
€395.12
Excluding VAT