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About This Item
Full Description
Specifically, this document addresses the following:
- test sample selection;
- selection of representative portions from a medical device;
- test sample preparation;
- experimental controls;
- selection of, and requirements for, reference materials;
- preparation of extracts.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
Document History
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ISO 10993-12:2021
viewing
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials- Most Recent
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ISO 10993-12:2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials- Historical Version
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ISO 10993-12:2007
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials- Historical Version
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ISO 10993-12:2002
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials- Historical Version