AAMI/ISO 10993-10:2010/(R)2014 PDF

Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. 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, and; 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.

ANSI :	ANSI Approved
File Size :	1 file , 510 KB
ISBN(s) :	1570203954
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	88
Published :	09/04/2010
Same As :	AAMI/ISO 10993-10:2010/(R)2014