UNI EN ISO 10993-12 : 2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definition
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
Bibliography
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

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.