UNE-EN ISO 10993-12:2022

This document 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

test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document

addresses the following:

test sample selection;

selection of representative portions from a medical device;

test sample preparation;

experimental controls;

selection of, and requirements, for reference materials;

preparation of extracts.

This document is not applicable to live cells, but can be relevant to the material or medical device

components of combination products containing live cells.