BS-EN-ISO-11607-1 › Packaging for terminally sterilized medical devices

BS-EN-ISO-11607-1 - 2020/A1 EDITION - CURRENT
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What is BS EN ISO 11607-1:2009?

BS EN ISO 11607-1 sets out the requirements and test methods for materials, preformed sterile barrier systems and packaging that should keep medical equipment and instruments sterilised up until they are used. This standard applies to industry and healthcare facilities where medical devices are placed in sterile barrier systems and sterilised. BS EN ISO 11607-1 doesn’t cover all the requirements for packaging materials that are manufactured aseptically. Users might need to look at additional requirements for drug or device combinations.

How does it work?

BS EN ISO 11607-1 looks at quality systems, including sampling, test methods and documentation. The standard also defines the different materials and preformed sterile barrier systems, before focussing on microbial barrier properties. It also explains compatibility with the sterilisation process and labelling system, as well as design and stability testing.

Who should buy it?

    Designers of packaging materials for sterilised medical equipment
    Industrial designers
    Quality assurers
    Regulatory bodies


Keywords

Sterilization (hygiene);Performance;Sterile equipment;Test methods;Seals;Packaging;Quality assurance systems;Wrapping;Medical equipment;Quality;Performance testing;Medical instruments;Packaging materials;Packages;Design;Compatibility

To find similar documents by classification:

11.080.30 (Sterilized packaging)

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Document Number

BS EN ISO 11607-1:2020+A1:2023

Revision Level

2020/A1 EDITION

Status

Current

Publication Date

Nov. 6, 2023

Replaces

BS EN ISO 11607-1:2017

Page Count

84

ISBN

9780539155587

International Equivalent

ISO 11607-1:2019/Amd.1:2023;EN ISO 11607-1:2020/A1:2023

Committee Number

CH/198