AAMI TIR17 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
Hardcopy , PDF
19-06-2019
English
01-01-2008
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Committee representation
Foreword
1 Scope
2 Definitions, symbols, and abbreviations
3 Selection of materials
4 Manufacturing process and design considerations
5 Material testing
6 Accelerated aging programs
Annex A (informative) - Radiation sterilization - Material
compatibility fundamentals
Annex B (informative) - Ethylene oxide sterilization - Material
compatibility fundamentals
Annex C (informative) - Moist heat sterilization - Material
compatibility fundamentals
Annex D (informative) - Dry heat sterilization - Material
compatibility fundamentals
Annex E (informative) - Hydrogen peroxide sterilization - Material
qualification fundamentals
Annex F (informative) - Nitrogen dioxide sterilization - Material
qualification fundamentals
Annex G (informative) - Peracetic acid (PA) vapor
sterilization - Material compatibility fundamentals
Annex H (informative) - Liquid peracetic acid
sterilization - Material compatibility fundamentals
Annex I (informative) - Hydrogen peroxideozone
sterilization - Material compatibility fundamentals
Annex J (informative) - Accelerated aging programs
Annex K (informative) - Example of a device evaluation process
Annex L (informative) - Material abbreviations
Bibliography
Gives guidance for health care product manufacturers in the selection and qualification of polymeric materials, ceramics, and metals for use in health care products sterilized by the following methods: - Radiation (gamma, electron beam, or x-ray) - Ethylene oxide (EO) - Moist heat (steam) - Dry heat - Hydrogen peroxide - Nitrogen dioxide - Vaporized peracetic acid - Liquid peracetic acid and - Hydrogen peroxide-ozone.
| DevelopmentNote |
Supersedes AAMI ST32 (07/2002)
|
| DocumentType |
Standard
|
| Pages |
96
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137:1995 | Identical |
| AAMI ISO 11137-1 : 2006 : R2010 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| AAMI ISO 11137-1:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| AAMI TIR42 : 2010 | EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| ASTM F 2529 : 2013 | Standard Guide for <emph type="bdit">in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
| BS ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
| AAMI TIR56:2013(R2020) | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| BS EN ISO 11137-1:2015 | Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices |
| AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI TIR56 : 2013 | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| PD ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| UNE-EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| I.S. EN ISO 11137-1:2015 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| 04/30048301 DC : DRAFT MAY 2004 | BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI TIR37 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
| ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
| DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| AAMI ISO 11137-2 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ANSI/AAMI/ISO 10993-3:2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| 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 |
| ASTM D 5587 : 2015 : REDLINE | TEST METHOD FOR TEARING STRENGTH OF FABRICS BY TRAPEZOID PROCEDURE |
| ASTM D 1004 : 2013 : REDLINE | Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting |
| ASTM F 1929 : 2015 : REDLINE | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ISO 604:2002 | Plastics — Determination of compressive properties |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| ANSI/AAMI/ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| AAMI ISO 10993-17 : 2002 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ASTM F 1980 : 2016 : REDLINE | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ISO/TR 8550-1:2007 | Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling |
| ANSI/AAMI/ISO 10993-6:2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| ANSI/AAMI/ISO TIR10993-20:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ASTM D 1746 : 2015 : REDLINE | Standard Test Method for Transparency of Plastic Sheeting |
| ASTM D 1822 : 2013 : REDLINE | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| AAMI ISO 10993-4 : 2002 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| ISO 178:2010 | Plastics Determination of flexural properties |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| ISO 6383-1:2015 | Plastics Film and sheeting Determination of tear resistance Part 1: Trouser tear method |
| ISO 868:2003 | Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness) |
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