AS ISO 10993.17-2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
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30-06-2017
English
01-01-2004
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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