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Norm

ÖNORM EN ISO 11607-1

Issue date: 2009 12 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 ar...

Withdrawn : 2014 11 15

§ Legal References

Publisher:

Austrian Standards International

Format:

Digital | 31 Pages

Language:

German | English | Download GER/ENG

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

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.

ÖNORM EN ISO 11607-1

2022 12 01