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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