ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
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.
ISO 10993-12:2007 is not applicable to materials or devices containing live cells.