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    I.S. EN ISO 11607-2:2017 & LC:2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 11607-2:2006, INCLUDING AMD 1:2014)

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-01-2020

    Language(s): 

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    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 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

    Abstract - (Show below) - (Hide below)

    Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized.

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

    Committee TC 198
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By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
    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
    AAMI ST33 : 2ED 96 GUIDELINES FOR THE SELECTION AND USE OF REUSABLE RIGID CONTAINER SYSTEMS FOR ETHYLENE OXIDE STERILIZATION AND STEAM STERILIZATION IN HEALTH CARE FACILITIES
    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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