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ISO 11607-2:2019

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 11607-2:2019
Document Year: 2019
Pages: 13
Edition: 2
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products

Life Cycle

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ISO 11607-2:2019
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