ISO 10993-10:2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Hardcopy , PDF
English, French
27-07-2010
09-04-2025
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
- pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vivo (irritation and sensitization) test procedures;
- key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO/DIS 10993-10. (07/2010)
|
| DocumentType |
Standard
|
| Pages |
67
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DS EN ISO 10993-10 : 2013 | Identical |
| DIN EN ISO 10993-10:2003-02 | Identical |
| DIN EN ISO 10993-10:2014-10 | Identical |
| GOST ISO 10993-10 : 2011 | Identical |
| NBN EN ISO 10993-10 : 2013 | Identical |
| NEN EN ISO 10993-10 : 2013 | Identical |
| NS EN ISO 10993-10 : 2013 | Identical |
| I.S. EN ISO 10993-10:2013 | Identical |
| PN EN ISO 10993-10 : 2015 | Identical |
| SS-EN ISO 10993-10 : 2013 | Identical |
| BS EN ISO 10993-10:2013 | Identical |
| EN ISO 10993-10:2013 | Identical |
| NF EN ISO 10993-10 : 2013 | Identical |
| BS EN ISO 10993-10:2010 | Equivalent |
| I.S. EN ISO 10993-10:2010 | Equivalent |
| DIN EN ISO 10993-10:2010-12 | Equivalent |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | Identical |
| UNE-EN ISO 10993-10:2011 | Identical |
| BS EN ISO 10993-10:2010 | Identical |
| AAMI BE78 : 2002 | Identical |
| UNE-EN ISO 10993-10:2013 | Identical |
| GOST R ISO 10993-10 : 2009 | Identical |
| AAMI ISO 10993-10 : 2010 | Identical |
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