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ISO 11607-2:2019

Current Revision

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

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11607
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
Publish Date Document Id Type View
Not Available ISO 11607-2:2019 Revision