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  • PREN 868-8 : DRAFT 2017

    Current The latest, up-to-date edition.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Language(s): 

    Published date:  22-08-2017

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Information to be supplied by the manufacturer
    Annex A (informative) - Details of significant technical
            changes between this European Standard and the
            previous edition
    Annex B (informative) - Guidance on dimensions
    Annex C (normative) - Carrying device strength test
    Annex D (normative) - Stacking test - Procedure
    Annex E (normative) - Stacking device capability test
    Annex F (normative) - Determination of sterilization
            performance
    Annex G (normative) - Load dryness tests
    Annex H (informative) - Guidance on determination
            of useful life with respect tO sterilization
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

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

    Comment Closes On
    Committee TC 102
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Current

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

    BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 4582:2017 Plastics — Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources
    EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
    PREN ISO 17664 : DRAFT 2001 STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
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