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  • BS EN 868-1:1997

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  26-10-2018

    Language(s):  English

    Published date:  15-12-1997

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    5 Test methods
    6 Documentation
    7 Information
    Annex A (informative) Guidance on clause 4
    Annex B (informative) Microbial barrier evaluation scheme
    Annex C (informative) Air impermeability - Test methods
    Annex D (informative) Microbial barrier properties -
            Test methods for materials
    Annex E (informative) Microbial barrier properties -
            Test methods for permeable closures (filter assembly,
            tortuous path)
    Annex F (informative) Impermeability and continuity of seals
            formed by fusion or adhesion - Test methods
    Annex G (informative) Impermeability of seals not formed by
            fusion or adhesion - Test methods - Test procedure
            for rigid containers
    Annex H (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
            addressing essential requirements or other provision
            of EU Directives

    Abstract - (Show below) - (Hide below)

    Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.

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

    Committee CH/198
    Development Note Supersedes 92/58621 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Superseded By
    Supersedes

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

    BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes General requirements

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    PREN 868-8 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
    DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
    PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    PREN 868-5 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    ISO 5636-2:1984 Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
    ISO 5636-5:2013 Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ASTM F 1608 : 2016 : REDLINE Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    PREN 868-2 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
    EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
    PREN 868-4 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
    ISO 9001:2015 Quality management systems — Requirements
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    BS 6255:1989 Specification for plain sterilization paper for medical use
    PREN 868-7 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
    PREN 868-3 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
    PREN 868-6 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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