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BS EN ISO 11607-2:2020

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Packaging for terminally sterilized medical devices Validation requirements for forming, sealing and assembly processes
Available format(s)

Hardcopy , PDF

Withdrawn date

13-09-2022

Language(s)

English

Published date

20-01-2020

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.

It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Committee
CH/198
DocumentType
Standard
ISBN
9780539038385
Pages
24
ProductNote
THIS STANDARD ALSO REFERS TO :ISO 11607-1:2018
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
EN ISO 11607-2:2020 Identical
ISO 11607-2:2019 Identical
EN ISO 11607-2:2017 Identical

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