scope:

This part of ISO 10993 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 of ISO 10993 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 part of ISO 10993 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.