• BS PD CEN ISO/TS 16775 : 2014

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    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Guidance for health care facilities
    4 Guidance for industry
    Annex A (informative) - Selection, evaluation
            and testing of packaging materials and
            sterile barrier systems - Guidance for
            industry and health care facilities
    Annex B (informative) - Sterilization
            considerations - Guidance for industry
            and health care facilities
    Annex C (informative) - Examples of
            wrapping methods - Guidance for health
            care facilities
    Annex D (informative) - Validation plan
            documents - Guidance for health care facilities
    Annex E (informative) - Installation qualification
            documentation - Guidance for health care facilities
    Annex F (informative) - Operational qualification
            documentation - Guidance for health care facilities
    Annex G (informative) - Performance qualification
            documentation - Guidance for health care facilities
    Annex H (informative) - Addressing worst-case
            requirements - Guidance for industry and health
            care facilities
    Annex I (informative) - Generating a final packaging
            system validation protocol - Guidance for industry
    Annex J (informative) - Design inputs - Medical device
            attributes - Guidance for industry
    Annex K (informative) - Risk analysis tools - Guidance
            for industry and health care facilities
    Annex L (informative) - Considerations for sampling
            plans - Guidance for health care facilities
    Annex M (informative) - Stability testing
            (ISO 11607-1:2006, 6.4) - Guidance for industry
    Annex N (informative) - Use of the Internet - Guidance for
            industry and health care facilities
    Annex O (informative) - Test method validation -
            Guidance for industry
    Annex P (informative) - Use of contract packagers -
            Guidance for industry and health care facilities
    Annex Q (informative) - Guidance on establishing process
            parameters - Guidance for industry
    Annex R (informative) - Investigation failure -
            Guidance for industry and health care facilities
    Annex S (informative) - Packaging manufacturing
            process and packaging system design feasibility
            evaluation - Guidance for industry
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.

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

    Committee CH/198
    Development Note Reviewed and confirmed by BSI, April 2018. (04/2018)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Superseded By

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

    EN 13430 : 2004 PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE BY MATERIAL RECYCLING
    ASTM F 1327 : 2005 Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    ASTM D 1894 : 2014 : REDLINE Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    ASTM D 3420 : 2014 : REDLINE Standard Test Method for Pendulum Impact Resistance of Plastic Film
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    AAMI ST58 : 2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    ASTM F 2475 : 2011 : REDLINE Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    EN 60118-13:2011 ELECTROACOUSTICS - HEARING AIDS - PART 13: ELECTROMAGNETIC COMPATIBILITY (EMC)
    CFR 21(PTS170-199) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 13427 : 2004 PACKAGING - REQUIREMENTS FOR THE USE OF EUROPEAN STANDARDS IN THE FIELD OF PACKAGING AND PACKAGING WASTE
    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
    DIN 58921:2011-01 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
    IEC 60118-13:2016 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
    ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
    ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    DIN 58953-6:2016-12 STERILIZATION - STERILE SUPPLY - PART 6: MICROBIAL BARRIER TESTING OF PACKAGING MATERIALS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED
    ASTM F 2029 : 2016 : REDLINE Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI TIR35 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
    ASTM D 4321 : 2015 : REDLINE Standard Test Method for Package Yield of Plastic Film
    EN 13429 : 2004 PACKAGING - REUSE
    AAMI TIR33 : 2005 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX
    ASTM F 2096 : 2011 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    AAMI TIR28 : 2016 PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    ASTM D 2457 : 2013 : REDLINE Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
    ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    ISO 14708-1:2014 Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 1924-2:2008 Paper and board Determination of tensile properties Part 2: Constant rate of elongation method (20 mm/min)
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    EN 13431 : 2004 PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE IN THE FORM OF ENERGY RECOVERY, INCLUDING SPECIFICATION OF MINIMUM INFERIOR CALORIFIC VALUE
    EN 13428 : 2004 PACKAGING - REQUIREMENTS SPECIFIC TO MANUFACTURING AND COMPOSITION - PREVENTION BY SOURCE REDUCTION
    DIN 58953-8:2010-05 STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ASTM D 1003 : 2013 : REDLINE Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM F 1886 : 1998 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 534:2011 Paper and board — Determination of thickness, density and specific volume
    ASTM D 1922 : 2015 : REDLINE Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
    EN 13432:2000/AC:2005 PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE THROUGH COMPOSTING AND BIODEGRADATION - TEST SCHEME AND EVALUATION CRITERIA FOR THE FINAL ACCEPTANCE OF PACKAGING
    ASTM F 1980 : 2016 : REDLINE Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
    ISO/ASTM 51649:2015 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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
    AAMI ST63 : 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
    ISO 15747:2010 Plastic containers for intravenous injections
    ASTM F 1306 : 2016 : REDLINE Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
    ASTM F 904 : 2016 : REDLINE Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
    ASTM F 1249 : 2013 : REDLINE Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ASQ Z1.9:2003 (R2013) Sampling Procedures And Tables For Inspection By Variables For Percent Nonconforming
    ASTM D 589 : 1997 Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing)
    AAMI TIR20 : 2001 PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
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