AS ISO 10993.17-2004
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Biological evaluation of medical devices – Establishment of allowable limits for leachable substances
Standards Australia , 01/01/2004
Pages: 25
Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO 10993-17:2002.
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