I.S. EN ISO 10993-12:2021

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Reference materials (RMs)
6 Use of RMs as experimental controls
7 Test sample selection
8 Test sample and RM preparation
9 Selection of representative portions from a medical device
10 Preparation of extracts of samples
11 Records
Annex A (informative) Experimental controls
Annex B (informative) General principles on, and practices of, test sample preparation and
sample selection
Annex C (informative) Principles of test sample extraction
Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation
Bibliography

This document 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.