I.S. EN ISO 10993-10:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
Hardcopy , PDF
English
01-01-2013
19-12-2023
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 principles - Step-wise approach
5 Pretest considerations
6 Irritation tests
7 Skin sensitization tests
8 Key factors in interpretation of test results
Annex A (normative) - Preparation of materials for
irritation/sensitization testing
Annex B (normative) - Special irritation tests
Annex C (normative) - Human skin irritation test
Annex D (informative) - In vitro tests for skin irritation
Annex E (informative) - Method for the preparation of extracts
from polymeric test materials
Annex F (informative) - Background information
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Bibliography
Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
| DocumentType |
Standard
|
| Pages |
85
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN ISO 10993-10:2003-02 | Identical |
| ISO 10993-10:2010 | Identical |
| DIN EN ISO 10993-10:2014-10 | Identical |
| NS EN ISO 10993-10 : 2013 | Identical |
| EN ISO 10993-10:2013 | Identical |
| NF EN ISO 10993-10 : 2013 | Identical |
| NBN EN ISO 10993-10 : 2013 | Identical |
| NEN EN ISO 10993-10 : 2013 | Identical |
| BS EN ISO 10993-10:2013 | Identical |
| UNE-EN ISO 10993-10:2013 | Identical |
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