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BS EN ISO 10993-12:2009

Biological evaluation of medical devices-Sample preparation and reference materials

standard by British Standard / European Standard / International Organization for Standardization , 07/31/2009

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About This Item

 

Full Description

BS EN ISO 10993-12:2009 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 BS EN ISO 10993-12:2009 addresses:

- test sample selection;

- selection of representative portions from a device;

- test sample preparation;

- experimental controls;

- selection of and requirements for reference materials;

- preparation of extracts.

BS EN ISO 10993-12:2009 is not applicable to materials or devices containing live cells.



Cross References:
ISO 10993-1:2003
ISO 14971
ISO Guide 30
ISO Guide 31
ISO Guide 33
ISO Guide 34
ISO Guide 35
NF S 90-701
93/42/EEC
90/385/EEC


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

Product Details

Published:
07/31/2009
ISBN(s):
9780580658273
Number of Pages:
28
File Size:
1 file , 1.2 MB
Same As:
ISO 10993-12:2007
Product Code(s):
30195372, 30195372, 30195372
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 10993-12:2021


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Most Recent

  2. BS EN ISO 10993-12:2012


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Historical Version

  3. BS EN ISO 10993-12:2009

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    viewing


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Historical Version

  4. BS EN ISO 10993-12:2007


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Historical Version

  5. BS 06/30145887 DC


    EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

    • Historical Version

  6. BS EN ISO 10993-12:2004


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Historical Version

  7. BS EN ISO 10993-12:1997


    Biological evaluation of medical devices-Sample preparation and reference materials

    • Historical Version