Abstract

This Uganda Standard specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. 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. (This standard cancels and replaces the second edition, US ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, which has been withdrawn). This standard was published on 2022-02-04