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.
Document identifier
AAMI TIR17:2017
Title
Compatibility of materials subject to sterilization
AAMI Category
General and Miscellaneous
Publication date
2017-06-11
International Relationship
History of version
AAMI TIR17:2017 * AAMI TIR17:2008 * AAMI TIR17:1997
| Price |
259 vnd |
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