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  • UNI EN ISO 11607-2 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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): 

    Superseded date:  19-03-2020

    Language(s): 

    Published date:  01-01-2014

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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.

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

    Committee U42.12
    Development Note Italian version issued in December 2014. (12/2014)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    UNI/TR 11408 : 2011 GUIDE TO DESIGN, DEVELOPMENT AND CONTROL OF A RECONDITION PROCESS FOR REUSABLE MEDICAL DEVICES THAT SHALL BE STERILIZED BY STEAM

    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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