ÖNORM EN ISO 11607-1

Issue date: 2007 06 01

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that a...

Withdrawn: 2010 01 01

Publisher:

Austrian Standards International

Format:

Digital | 31 Pages

Language:

German | English

Currently valid:

ÖNORM EN ISO 11607-1:2022 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

Summary

Norm timeline

Normative References

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. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

ÖNORM EN ISO 11607-1

2022 12 01