ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of, and requirements for, reference materials;
- preparation of extracts.
ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Reference materials (RMs)
5.1 General
5.2 Certification of RMs for biological safety testing
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
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 the exaggerated-use condition (points to consider in relation to Annex D)
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
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Reference materials (RMs)
5.1 General
5.2 Certification of RMs for biological safety testing
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
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 the exaggerated-use condition (points to consider in relation to Annex D)
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