Standard Swedish standard · SS-EN ISO 10993-3:2004

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Status: Withdrawn

· Replaced by: SS-EN ISO 10993-3:2009
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Standard Swedish standard · SS-EN ISO 10993-3:2004

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
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Scope
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
-- genotoxicity,
-- carcinogenicity, and
-- reproductive and developmental toxicity.
This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
NOTE Guidance on selection of tests is provided in ISO 10993-1.

Subjects

Biological evaluation of medical devices (11.100.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 10993-3:2004

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-35383

Edition: 1

Approved: 2/6/2004

No of pages: 23

Replaces: SS-EN 30993-3

Replaced by: SS-EN ISO 10993-3:2009