Standard Swedish standard · SS-EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Status: Valid

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Standard Swedish standard · SS-EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
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Scope
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:— genotoxicity;— carcinogenicity;— reproductive and developmental toxicity.This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.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 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

Price: 2 112 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-103225

Edition: 3

Approved: 10/19/2014

No of pages: 52

Replaces: SS-EN ISO 10993-3:2009