Standard

NS-EN ISO 11607-2:2017

Oct 2017 Withdrawn

Note: This standard has a new edition: NS-EN ISO 11607-2:2020

Corrigendums and amendments are bought separately.

Language English

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Abstract

ISO 11607-2:2006 specifies the requirements for 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. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Document information

Standard from SN
Published: 1 October 2017
Withdrawn: 1 March 2020
Edition: 2017-07
Version: 1
Document type: NAT
ISBN:

ICS 11.080.30
National Committee SN/K 108

Legal references

EU law: 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 11607-2:2020
Referred by: NS-EN ISO 10451:2010
Referred by: NS-EN ISO 22794:2009
Replaces: NS-EN ISO 11607-2:2006
Adopted from: EN ISO 11607-2:2017 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 11607-2:2006/A1:2014

Withdrawn

NS-EN ISO 11607-2:2006
Current product

Withdrawn

NS-EN ISO 11607-2:2017
Replaced by

Published

NS-EN ISO 11607-2:2020

NS-EN ISO 11607-2:2017

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NS-EN ISO 11607-2:2020