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

BS-EN-ISO-11607-1 - 2020/A11 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);Quality;Performance;Compatibility;Quality assurance systems;Packaging;Seals;Design;Packages;Test methods;Wrapping;Sterile equipment;Performance testing;Medical equipment;Packaging materials;Medical instruments

To find similar documents by classification:

11.080.30 (Sterilized packaging)

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Document Number

BS EN ISO 11607-1:2020

Revision Level

2020/A11 EDITION

Status

Current

Publication Date

March 3, 2020

Page Count

58

ISBN

9780539131918

International Equivalent

EN ISO 11607-1:2020;ISO 11607-1:2019

Committee Number

CH/198