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  • 17/30351720 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Validation of packaging processing
    6 Packaging system assembly
    7 Use of reusable sterile barrier systems
    8 Sterile fluid-path packaging
    Annex A (informative) - Process development
    Annex B (informative) - Draft guidance on the
            relationship between this standard and the
            general safety and performance requirements
            of Regulation (EU) 2017/745 of the European
            Parliament and of the Council of 5 April 2017
            on medical devices, amending Directive 2001/83/EC,
            Regulation (EC) No 178/2002 and Regulation (EC)
            No 1223/2009 and repealing Council Directives
            90/385/EEC and 93/42/EEC
    Annex C (informative) - Draft guidance on the relationship
            between this standard and general safety and performance
            requirements of Regulation (EU) 2017/746 of the European
            Parliament and of the Council of 5 April 2017 on in vitro
            diagnostic medical devices and repealing Directive 98/79/EC
            and Commission Decision 2010/227/EU
    Annex ZA (informative) - Relationship between this European
             Standard and the essential requirements of Directive 93/42/EEC
             [OJ L 169] aimed to be covered
    Annex ZB (informative) - Relationship between this European
             Standard and the essential requirements of Directive
             90/385/EEC [OJ L 189] aimed to be covered
    Annex ZC (informative) - Relationship between this European
             Standard and the essential requirements of Directive
             98/79/EC [OJ L 331] aimed to be covered
    Bibliography

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

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

    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
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ISO 186:2002 Paper and board — Sampling to determine average quality
    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
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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
    AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
    DIN 58953-9:2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container
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