標(biāo)準(zhǔn)號(hào)：BS EN ISO10993-10-2002
中文標(biāo)準(zhǔn)名稱：醫(yī)療器械的生物評(píng)定.刺激與持續(xù)過敏癥試驗(yàn)
英文標(biāo)準(zhǔn)名稱：Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
標(biāo)準(zhǔn)類型：C04
發(fā)布日期：2002/10/8 12:00:00
實(shí)施日期：2002/10/8 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C04
國際標(biāo)準(zhǔn)分類號(hào)：11.100.20
適用范圍：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 pretest considerations, details of the test procedures, and key factors for the interpretation of the results.Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.