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I.S. EN ISO 11607-2:2020

Current
Current

The latest, up-to-date edition.

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Amended by

I.S. EN ISO 11607-2:2020/A1:2023

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-23-2020

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) Process development
Bibliography

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.

Committee
CEN/TC 102
DocumentType
Standard
Pages
30
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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

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Hardcopy - English
PDF - English
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