AAMI TIR17:2017(R2023)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Compatibility of materials subject to sterilization
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
20-07-2023
Superseded date
26-12-2024
Superseded by
€265.83
Excluding VAT
This document provides 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 • Hydrogen peroxide–ozone NOTE—All references to hydrogen peroxide sterilization in this TIR refer to sterilization in the gas phase.
| DocumentType |
Standard
|
| ISBN |
9781570207006
|
| Pages |
123
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI TIR56:2013(R2024) | Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices |
| ISO 178:1993 | Plastics — Determination of flexural properties |
| ANSI/AAMI/ISO 10993-13:2010(R2014) | Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices. |
| AAMI ISO 10993-15 : 2000 : R2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| ASTM D 412 : 2016 : REDLINE | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| ASTM G 31 : 1972 : R2004 | Standard Practice for Laboratory Immersion Corrosion Testing of Metals |
| ISO 527-1:1993 | Plastics — Determination of tensile properties — Part 1: General principles |
| 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 |
| AAMI ISO 11137-3 : 2006 : R2010 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL |
| ASTM F 2054/F2054M : 2013 : REDLINE | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
| AAMI ISO 10993-6 : 2007 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| ASTM D 5034 : 2009 : R2013 | Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) |
| ASTM D 1004 : 2013 : REDLINE | Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting |
| ANSI/AAMI/ISO 10993-2:2006(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS |
| ASTM D 5035 : 2011 : R2015 | Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) |
| ANSI/AAMI/ISO 10993-5:2009(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
| ASTM F 1980 : 2016 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ANSI/AAMI BE83:2006(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| ASTM E 313 : 2010 | Standard Practice for Calculating Yellowness and Whiteness Indices from Instrumentally Measured Color Coordinates |
| ASTM F 1929 : 2015 : REDLINE | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| 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 |
| AAMI ISO 10993-7:2008(R2012) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| ANSI/AAMI/ISO 10993-17:2002(R2012) | Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachable substances. |
| ISO 604:2002 | Plastics — Determination of compressive properties |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| ASTM D 785 : 2008 : R2015 | Standard Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials |
| ANSI/AAMI/ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| AAMI ISO 10993-11 : 2006 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
| AAMI ISO 10993-16 : 2010 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| 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 10993-9:2009(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| 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 |
| AAMI ST40 : 2004 : R2010 | TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ASTM D 1822 : 2013 : REDLINE | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| ANSI/AAMI/ISO 10993-14:2001(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| AAMI ISO 11607-1 : 2006 : R2010 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| AAMI ISO 11607-2 : 2006 : R2010 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
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