AS ISO 10993.17-2004 PDF

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Biological evaluation of medical devices – Establishment of allowable limits for leachable substances
standard by Standards Australia, 01/01/2004

Document Format: PDF

Description

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.

Product Details

Edition:
1st
Published:
01/01/2004
ISBN(s):
0733762271
Number of Pages:
25
File Size:
1 file , 810 KB
Product Code(s):
10159165, 10159173, 10159143
Note:
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