NEN EN ISO 10993-12 : 2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Experimental controls
5 Reference materials
   5.1 General
   5.2 Certification of RMs for biological safety testing
6 Use of RMs as experimental controls
7 Test material selection
8 Test sample and RM preparation
9 Selection of representative portions from a device
10 Preparation of extracts of samples
   10.1 General
   10.2 Containers for extraction
   10.3 Extraction conditions and methods
   10.4 Extraction conditions for hazard identification and
        risk estimation in exaggerated-use condition
11 Records
Annex A (informative) Experimental controls
Annex B (informative) General principles and practices of test
        material preparation and sample selection
Annex C (informative) Principles of test material extraction
Bibliography

Defines 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 systems in accordance with one or more parts of ISO 10993.