UNI 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
04-05-2023
24-10-2013
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.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-10 : 2014 | Identical |
| DIN EN ISO 10993-10:2003-02 | Identical |
| ISO 10993-10:2010 | Identical |
| DIN EN ISO 10993-10:2014-10 | Identical |
| I.S. EN ISO 10993-10:2013 | Identical |
| NS EN ISO 10993-10 : 2013 | Identical |
| EN ISO 10993-10:2013 | Identical |
| NF EN ISO 10993-10 : 2013 | Identical |
| UNE-EN ISO 10993-10:2013 | Identical |
| SN 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 |
| UNI 11533 : 2014 | MASS-PRODUCED ORTHOPEDIC FOOTWEAR DESIGNED FOR FOOT ORTHOTIC - SAFETY AND PERFORMANCE REQUIREMENTS AND TEST METHODS |
| ISO 9394:2012 | Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
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