DIN EN ISO 10993-10:2007
医用设备的生物学评估.第10部分:刺激和延迟型超敏性的试验

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002+Amd.1:2006); German version EN ISO 10993-10:2002+A1:2006

作废

标准号

DIN EN ISO 10993-10:2007

发布

2007年

发布单位

德国标准化学会

替代标准

DIN EN ISO 10993-10:2009

DIN EN ISO 10993-10 E:2008-08

当前最新

DIN EN ISO 10993-10:2023-04

 

 

适用范围

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes a) pretest considerations, b) details of the 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. Supplementary tests which are required specifically for devices used intradermally and in the ocular,oral,rectal,penile and vaginal areas are given in annex B.

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