DR 03508 CP
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
30-06-2017
13-10-2003
Proposes adoption of ISO 10993-17:2002 to provide 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.
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