Skip to content
Please enter a keyword to search

  • PD CEN ISO/TS 16775:2014

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

    Available format(s):  Hardcopy, PDF

    Superseded date:  26-11-2021

    Language(s):  English

    Published date:  31-05-2014

    Publisher:  British Standards Institution

    Add To Cart

    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.

    Scope - (Show below) - (Hide below)

    This Technical Specification provides guidance for the application of the requirements contained in ISO11607-1 and ISO11607-2. It does not add to, or otherwise change, the requirements of ISO11607-1 and/or ISO11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities.

    The guidance can be used to better understand the requirements of ISO11607-1 and/or ISO11607-2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate compliance with them.

    Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.

    This Technical Specification provides information for health care facilities (see Clause3) and for the medical devices industry (see Clause4).

    It does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.

    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 Superseded
    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
    ANSI/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
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective