AAMI TIR17:2017(R2023)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
12-26-2024
English
07-20-2023
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Superseded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 |
| ISO 178:1993 | Plastics — Determination of flexural properties |
| ASTM D 412 : 2016 : REDLINE | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| 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 |
| ASTM F 2054/F2054M : 2013 : REDLINE | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
| 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 |
| ASTM D 5035 : 2011 : R2015 | Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) |
| ASTM F 1980 : 2016 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 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 |
| ISO 604:2002 | Plastics — Determination of compressive properties |
| ASTM D 785 : 2008 : R2015 | Standard Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials |
| 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 |
| ASTM D 1822 : 2013 : REDLINE | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
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