DS/EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Standard No.

DS/EN ISO 11607-1:2009

Release Date

2009

Published By

Danish Standards Foundation

Latest

DS/EN ISO 11607-1:2009

Replace

DS/EN ISO 11607-1:2006

Scope

This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.Th

DS/EN ISO 11607-1:2009 history

• 2009 DS/EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• 0000 DS/EN ISO 11607-1:2006