I.S. EN ISO 10993-12:2021
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Hardcopy , PDF
English
04-07-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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 medical 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
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