BS EN 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.
BS EN ISO 10993-10:2010 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Cross References:ISO 10993-1:2009
ISO 10993-2
ISO 10993-9
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-18
ISO 14155-1
ISO 14155-2
88/379/EEC
ISO 9394
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1.4 MB |
| ISBN(s) : | 9780580789069, 9780580600333 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 76 |
| Product Code(s) : | 30263004, 30263004 |
| Published : | 04/30/2012 |
| Same As : | BS EN ISO 10993-10:2010 |
