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AAMI TIR17:2008

Compatibility of materials subject to sterilization

Provide guidance for health care manufacturers in the qualification of polymeric materials, ceramics, and metals 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; and f) ozone. Annexes address the specific sterilization modality concerns.

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Association for the Advancement of Medical Instrumentation [aami]

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