Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2010); German version prEN ISO 10993-12:2010
Project begin
2009-08-04
WI
00206063
Planned document number
DIN EN ISO 10993-12
Abstract
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 devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part addresses: test material selection; selection of representative portions from a device;
test sample preparation; experimental controls; selection of and requirements for reference materials; and, preparation of extracts. The applicability of this standard to absorbable materials, materials that polymerize in-situ, tissue engineered medical products and materials of biological origin should be carefully evaluated.
Responsible Committee
NA 027-02-12 AA Biological evaluation of medical devices
Notice of supersedure
Vorgesehen als Ersatz für DIN EN ISO 10993-12:2009-08
Draft standard
Previous Document(s)
Search in NA 027
Contact
Dipl.-Ing.
Karl Wenzelewski
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