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ISO 11607-2:2019

Current

Current

The latest, up-to-date edition.

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

31-01-2019

€92.00
Excluding VAT

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
ISO/TC 198
DocumentType
Standard
Pages
13
ProductNote
THIS STANDARD ALSO REFERS TO EN 13795-1,ANSI/AAMI ST65,ANSI/AAMI ST77,ANSI/AAMI ST90,ISO 11607-1:2018
PublisherName
International Organization for Standardization
Status
Current
Supersedes

SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide

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