AS ISO 10993.17-2004

Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

Standards Australia, 01/01/2004

Publisher: AS

File Format: PDF

$40.00$81.52

Description

Published:01/01/2004

Pages:25

File Size:1 file , 810 KB

Note:This product is unavailable in Ukraine, Russia, Belarus

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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