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Norm

ÖNORM EN ISO 11607-1

Issue date: 2022 12 01

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) (consolidated version)

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to...
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Publisher:
Austrian Standards International
Format:
Digital | 66 Pages
Language:
German | English | Download GER/ENG
This document specifies 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
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ÖNORM EN ISO 11607-1
2006 07 01
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ÖNORM EN 868-1
1997 08 01
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Historie aufklappen
Norm
ISO 5636-5:2013
Issue date : 2013 10 17
Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
Norm
ISO 11607-2:2019
Issue date : 2019 01 31
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes