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  • BS EN 868-1 : 1997

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    PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 1: GENERAL REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  26-10-2018

    Language(s):  English

    Published date:  01-01-1997

    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 LBI/35
    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    Status Withdrawn
    Superseded By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 - PART 1: 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
    BS 6257(1989) : 1989 SPECIFICATION FOR PAPER BAGS FOR STEAM STERILIZATION FOR MEDICAL USE
    BS 6254(1989) : 1989 SPECIFICATION FOR CREPED STERILIZATION PAPER FOR MEDICAL USE
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS 6871(1989) : 1989 SPECIFICATION FOR HEAT-SEALABLE POUCHES AND TUBE MATERIAL CONVERTED FROM TRANSPARENT PLASTICS FILM AND PAPER FOR STEAM STERILIZATION FOR MEDICAL USE
    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
    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, BOARDS AND PULPS - STANDARD ATMOSPHERE FOR CONDITIONING AND TESTING AND PROCEDURE FOR MONITORING THE ATMOSPHERE AND CONDITIONING OF SAMPLES
    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) : 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
    BS 6256(1989) : 1989 SPECIFICATION FOR PAPER FOR STEAM STERILIZATION PAPER BAGS, POUCHES AND REELS FOR MEDICAL USE
    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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