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