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
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
40
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-12:2021 | Identical |
| ISO 10993-12:2021 | Identical |
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