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  • 04/30101211 DC : DRAFT APR 2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

    Available format(s): 

    Superseded date:  31-05-2006

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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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
      4.1 General
      4.2 Quality systems
      4.3 Test methods
      4.4 Documentation
    5 Material and preformed sterile barrier systems
      5.1 General requirements
      5.2 Microbial barrier properties
      5.3 Compatibility with the sterilization process
      5.4 Compatibility with the labelling system
      5.5 Storage and transport
    6 Design and development requirements for packaging systems
      6.1 General
      6.2 Design
      6.3 Packaging system performance testing
      6.4 Stability testing
    Annex A (informative) Guidance on medical packaging
          A.1 Factors influencing the choice of the materials and design
              of the packaging system
          A.2 Sterilization processes and considerations
          A.3 Sterile barrier systems
    Annex B (informative) Standardized test methods and procedures
            that may be used to demonstrate compliance with requirements
            of ISO 11607-1
          B.1 General
          B.2 Packaging materials and preformed sterile barrier systems
          B.3 Sterile barrier systems
    Annex C (normative) Test method for resistance of impermeable
            materials to passage of air
    Bibliography
    Annex ZA (informative) Relationship between this International
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on medical devices

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

    Comment Closes On
    Committee LBI/35/9
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By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 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    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 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    ISO 5636-1:1984 Paper and board Determination of air permeance (medium range) Part 1: General method
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 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
    AAMI ST65 : 2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    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
    ISO 186:2002 Paper and board Sampling to determine average quality
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 9001:2015 Quality management systems - Requirements
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
    ISO 13683:1997 Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
    EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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