DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2012); Deutsche Fassung EN ISO 10993-12:2012
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
