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
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