NEN EN ISO 10993-12 : 2012
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
01-12-2013
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
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