ISO 11607-2:2019 Preview

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

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
    Publication date : 2019-02
  • Edition : 2
    Number of pages : 13
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.30
    Sterilized packaging

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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