標(biāo)準(zhǔn)號(hào)：ANSI/AAMI/ISO 22442-1-2007
中文標(biāo)準(zhǔn)名稱(chēng)：醫(yī)療設(shè)備用動(dòng)物組織及其衍生物.第1部分:風(fēng)險(xiǎn)管理的應(yīng)用
英文標(biāo)準(zhǔn)名稱(chēng)：Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
標(biāo)準(zhǔn)類(lèi)型：C37
發(fā)布日期：2008/1/25 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類(lèi)號(hào)：C37
國(guó)際標(biāo)準(zhǔn)分類(lèi)號(hào)：11.040.99
適用范圍：Applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. Specifies, in conjunction with ISO 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.