DANSK DS/EN ISO 10993-12 PDF

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.