01/562154 DC : DRAFT JUNE 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BS EN ISO 10993-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
08-12-2004
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Experimental controls
5 Reference materials
5.1 General
5.2 Certification of reference materials for
biological safety testing
6 Use of reference materials as experimental controls
7 Test material selection
8 Test sample and reference material preparation
9 Selection of representative portions from devices
10 Preparations 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) Principles of test material preparation
B.1 General
Annex C (informative) Principles of test material extraction
C.1 General
Bibliography
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