I.S. EN ISO 10993-12:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Hardcopy , PDF
English
04-07-2021
10-10-2025
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.
Dates of withdrawal of national standards are available from NSAI.
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 |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-12:2021 | Identical |
| ISO 10993-12:2021 | Identical |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO Guide 33:2015 | Reference materials — Good practice in using reference materials |
| ISO Guide 35:2017 | Reference materials — Guidance for characterization and assessment of homogeneity and stability |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO Guide 31:2015 | Reference materials — Contents of certificates, labels and accompanying documentation |
| ISO 10993-9:2019 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
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