AAMI TIR17 : 2017

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COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

Publisher: Association for the Advancement of Medical Instrumentation

Published: 05-01-2018

Available Formats: PDF - English - DRM, Hardcopy - English
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This technical information report provides guidance for health care product manufacturers in the qualification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide•ozone. Annexes address the specific sterilization modality concerns.

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Published
Document Type	Standard
Status	Current
Publisher	Association for the Advancement of Medical Instrumentation
Pages
ISBN
Supersedes	AAMI TIR17 : 2008

Standards Referencing This Book - (Show below) - (Hide below)

AAMI ISO 10993-16 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
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
ASTM G 31 : 2012	GUIDE FOR LABORATORY IMMERSION CORROSION TESTING OF METALS
AAMI ISO 10993-10 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
AAMI ST40 : 2004	TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI ISO 11137-2 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ASTM D 5034 : 2009	TEST METHOD FOR BREAKING STRENGTH AND ELONGATION OF TEXTILE FABRICS (GRAB TEST)
AAMI ISO 10993-3 : 2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
AAMI ST58 : 2013(R2018)	CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
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 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM D 5035 : 2011	TEST METHOD FOR BREAKING FORCE AND ELONGATION OF TEXTILE FABRICS (STRIP METHOD)
ASTM D 5587 : 2015 : REDLINE	TEST METHOD FOR TEARING STRENGTH OF FABRICS BY TRAPEZOID PROCEDURE
ASTM E 313 : 2015-02	PRACTICE FOR CALCULATING YELLOWNESS AND WHITENESS INDICES FROM INSTRUMENTALLY MEASURED COLOR COORDINATES
ASTM D 1004 : 2013 : REDLINE	Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
AAMI ST50 : 2004	DRY HEAT (HEATED AIR) STERILIZERS
AAMI ISO 10993-9 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
ASTM F 88 : 2007-12	TEST METHOD FOR SEAL STRENGTH OF FLEXIBLE BARRIER MATERIALS
AAMI ISO 10993-7 : 2008	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
AAMI ISO 11607-1 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
AAMI 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
AAMI BE83 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
AAMI ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ASTM F 2054 : 2007	TEST METHOD FOR BURST TESTING OF FLEXIBLE PACKAGE SEALS USING INTERNAL AIR PRESSURIZATION WITHIN RESTRAINING PLATES
AAMI ISO 10993-5 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
ASTM F 1929 : 2015 : REDLINE	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
AAMI ISO 11137-3 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
AAMI ISO 10993-15 : 2000	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
AAMI ISO 11607-2 : 2006	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
AAMI ISO 10993-14 : 2001	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
ISO 604 : 2002	PLASTICS - DETERMINATION OF COMPRESSIVE PROPERTIES
AAMI ISO 14160 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO TIR 10993-19 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
ASTM D 883 : 2017-08	TERMINOLOGY RELATING TO PLASTICS
ASTM D 785 : 2008	TEST METHOD FOR ROCKWELL HARDNESS OF PLASTICS AND ELECTRICAL INSULATING MATERIALS
AAMI ISO 10993-11 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
AAMI 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
ASTM D 412 : 2016-12	TEST METHODS FOR VULCANIZED RUBBER AND THERMOPLASTIC ELASTOMERS - TENSION
AAMI ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ASTM D 882 : 2012-09	TEST METHOD FOR TENSILE PROPERTIES OF THIN PLASTIC SHEETING
AAMI ISO 10993-17 : 2002	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
AAMI ISO TIR 16775 : 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(R2017)	GUIDANCE ON THE SELECTION AND USAGE OF ACCEPTANCE SAMPLING SYSTEMS FOR INSPECTION OF DISCRETE ITEMS IN LOTS - PART 1: ACCEPTANCE SAMPLING
AAMI ST81 : 2004	STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
AAMI ISO 10993-6 : 2016	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
AAMI ISO TIR 10993-20 : 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 ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
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 10993-13 : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
AAMI ISO 10993-4 : 2002	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 178 : 2010(R2015)	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
AAMI ISO 10993-2 : 2006	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
ISO 868 : 2003(R2018)	PLASTICS AND EBONITE - DETERMINATION OF INDENTATION HARDNESS BY MEANS OF A DUROMETER (SHORE HARDNESS)

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AAMI TIR17 : 2017

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