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ONORM EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
This document specifies requirements and provides guidance on procedures for the manufacture of test pieces and for the selection of reference materials for the testing of medical devices, especially in biological test systems, in particular according to one or more parts of the ISO 10993 series of standards. This document deals in particular with the following aspects: - selection of test samples; - selection of representative parts of a medical device; - manufacture of test pieces, - checks on test methods, - selection of and requirements for the reference materials; - production of extracts. This document is not applicable to living cells, but may apply to materials and product components of combination products containing living cells. Extractions for chemical characterization are covered in ISO 10993-18. Section 7, Section 8, Section 9, Section 10 [except 10.3.5 and 10.3.11 b)] and Section 11 may be used for Extr ...
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Austrian Standards Institute [on]