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ISO 10993-12:2007

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

standard by International Organization for Standardization , 11/15/2007

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Identical versions for sale:
Outside United States: BS EN ISO 10993-12:2007
German: DIN EN ISO 10993-12:2007
Spanish: UNE EN ISO 10993-12:2007

ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:

  1. test sample selection;
  2. selection of representative portions from a device;
  3. test sample preparation;
  4. experimental controls;
  5. selection of and requirements for reference materials;
  6. preparation of extracts.

ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

 

Product Details

Published:
11/15/2007
File Size:
1 file , 210 KB
Same As:
BS EN ISO 10993-12:2009, DIN EN ISO 10993-12
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-12:2021


    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    • Most Recent

  2. ISO 10993-12:2012


    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    • Historical Version

  3. ISO 10993-12:2007

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    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    • Historical Version

  4. ISO 10993-12:2002


    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    • Historical Version