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  • BS EN ISO 11607-2 : 2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-05-2018

    Language(s):  English

    Published date:  01-01-2006

    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 processes
    6 Packaging system assembly
    7 Use of reusable sterile barrier systems
    8 Sterile fluid-path packaging
    Annex A (informative) - Process development
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices

    Abstract - (Show below) - (Hide below)

    Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

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

    Committee CH/198
    Development Note Supersedes 04/30101215 DC (05/2006) Supersedes 14/30255138 DC. 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. (09/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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
    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
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    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
    DIN 58953-9:2010-05 Sterilization - Sterile supply - Part 9: Use of sterilization container
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