EN ISO 10993-12:2012

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 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
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         90/385/EEC on active implantable medical devices
Bibliography

ISO 10993-12:2012 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 systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of, and requirements for, reference materials; preparation of extracts. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.