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About This Item

 

Full Description

BS EN ISO 10993-3:2009 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:

- genotoxicity,

- carcinogenicity, and

- reproductive and developmental toxicity.

BS EN ISO 10993-3:2009 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.

Cross References:
ISO 10993-1:1997
ISO 10993-2:1992
ISO 10993-6:1994
ISO 10993-12:2002
ISO 10993-18
OECD 414
OECD 415
OECD 416
OECD 421
OECD 451
OECD 453
OECD 471
OECD 473
OECD 476
OECD 474
OECD 475
OECD 478
OECD 479
OECD 480
OECD 481
OECD 482
OECD 483
OECD 484
OECD 485
OECD 486
ASTM F 1439-39
93/42/EEC


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 10993-3:2014


    Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Most Recent
  2. BS 11/30212473 DC


    BS EN ISO 10993-3. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version
  3. BS EN ISO 10993-3:2009

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    Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version
  4. BS EN ISO 10993-3:2003


    Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version
  5. BS EN 30993-3:1994


    Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version