ANSI/AAMI/ISO 22442-1-2007 标准详情
- 标准号:ANSI/AAMI/ISO 22442-1-2007
- 中文标题:医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
- 英文标题:Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- 标准类别:美国国家标准
- 发布日期:2008-01-25
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,
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