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