DIN EN ISO 10993-12:2012-10

This standard 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 series ISO 10993. Specifically, this part of ISO 10993 addresses the following: - 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. This standard is not applicable to materials or products containing live cells. This standard is directed at manufacturers of medical devices and test laboratories. The committee responsible for this standard is NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") at DIN.