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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
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This part of ISO 10993 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 this part of ISO 10993 addresses: - test sample selection; - selection of representative portions from a device; - test sample preparation; - selection of and requirements for reference materials; - preparation of extracts. This part of ISO 10993 is not applicable to materials or devices containing live cells.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
Medical devices
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Designation Name
SS-EN ISO 10993-12:2007
Revision Level
2007 EDITION
Status
Superseded
Publication Date
Nov. 26, 2007
Language(s)
English
Page Count
32
International Equivalent
EN ISO 10993-12:2007(IDT); ISO 10993-12-2007(IDT)