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Norm
ÖNORM EN ISO 11607-1
Issue date: 2018 04 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
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Withdrawn: 2020 04 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 47 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
This part of ISO 11607 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
2022 12 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN ISO 11607-1
2020 04 15
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN ISO 11607-1
2018 04 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
↖
ÖNORM EN ISO 11607-1
2014 11 15
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN ISO 11607-1
2009 12 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN ISO 11607-1
2007 06 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN ISO 11607-1
2006 07 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile ba...
Norm
ÖNORM EN 868-1
1997 08 01
Packaging materials and systems for medical devices which are to be sterilized - Part 1: General req...
Norm
Norm
Issue date :
2013 10 17
Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
Norm
Issue date :
2020 04 15
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)