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Norm

ÖNORM EN ISO 11607-2

Issue date: 2020 04 15

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include...

Withdrawn : 2022 12 01

§ Legal References

Publisher:

Austrian Standards International

Format:

Digital | 20 Pages

Language:

German | English | Download GER/ENG

Currently valid:

ÖNORM EN ISO 11607-2:2022 12 01

Optionally co-design standards:

Committee 215: Sterilization and disinfection of medical devices

ICS

11.080.30

Topics

Healthcare, Sterilization and disinfection of medical devices, Sterilized packaging

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.

ÖNORM EN ISO 11607-2

2022 12 01