UNI CEN ISO/TS 16775 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
04-14-2022
01-01-2014
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
Gives guidance on the application of ISO11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes.
| Committee |
U42.12
|
| DevelopmentNote |
Italian version issued in December 2014. (12/2014)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| 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 (Withdrawn 2024) |
| 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 |
| 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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