BS-EN-ISO-11607-1 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

BS-EN-ISO-11607-1 - 2017 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

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

To find similar documents by classification:

11.080.30 (Sterilized packaging)

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Price:

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Document Number

BS EN ISO 11607-1:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

May 15, 2018

Replaces

BS EN ISO 11607-1:2006 BS EN ISO 11607-1:2009+A1:2014

Page Count

44

ISBN

9780580964336

International Equivalent

EN ISO 11607-1:2017 ENISO 11607-1 ISO 11607-1 ISO 11607-1:2006

Committee Number

CH/198