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PD CEN ISO/TS 16775:2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date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

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

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

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.

Committee
CH/198
DevelopmentNote
Reviewed and confirmed by BSI, April 2018. (04/2018)
DocumentType
Standard
Pages
126
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
ISO/TS 16775:2014 Identical
CEN ISO/TS 16775:2014 Identical

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

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