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  • 14/30255138 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 11607-2:2006/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2014

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    BS EN ISO 11607-2:2006/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    Status Superseded
    Superseded By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
    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
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    DIN 58953-8:2010-05 STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    DIN 58953-7:2010-05 STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS
    DIN 58953-9:2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container
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