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  • 14/30255135 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2014

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Abstract - (Show below) - (Hide below)

    BS EN ISO 11607-1:2009/A1.

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/198
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ISO 5636-5:2013 Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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