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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
05-11-2021
Superseded by
Language(s)
Russian, English
Published date
09-05-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO/TS 16775:2014 provides guidance for the application of the requirements contained in ISO 116071 and ISO 116072. It does not add to, or otherwise change, the requirements of ISO 116071 and/or ISO 116072. It is an informative document, not normative, and 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 ISO 116071 and/or ISO 116072 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required to 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.
ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. 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.
| DocumentType |
Technical Specification
|
| Pages |
129
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM ONR CEN ISO/TS 16775 : 2014 | Identical |
| ANSI/AAMI/ISO TIR16775:2014 | Identical |
| NEN NPR CEN ISO/TS 16775 : 2014 | Identical |
| S.R. CEN ISO/TS 16775:2014 | Identical |
| UNI CEN ISO/TS 16775 : 2014 | Identical |
| PD CEN ISO/TS 16775:2014 | Identical |
| CEN ISO/TS 16775:2014 | Identical |
| CAN/CSA-ISO/TS 16775:17 | Identical |
| DIN CEN ISO/TS 16775;DIN SPEC 58997:2014-10 | Identical |
| 15/30321131 DC : 0 | BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| ASTM F 3263 : 2017 | Standard Guide for Packaging Test Method Validation |
| DIN EN ISO 11135:2014-10 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z314.14 : 2015 | SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 17/30351720 DC : 0 | BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
| EN 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 (ISO 11135:2014) |
| ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| I.S. EN ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| UNI EN 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 |
| 16/30280931 DC : DRAFT APR 2016 | BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| UNE-EN ISO 11135:2015 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| BS EN 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 |
| I.S. EN 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 (ISO 11135:2014) |
| EN ISO 17664:2017 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
| 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 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 |
| 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 |
| 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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