I.S. EN 13612-2002 标准详情
- 标准号:I.S. EN 13612-2002
- 中文标题:
- 英文标题:Performance Evaluation Of In Vitro Diagnostic Medical Devices
- 标准类别:爱尔兰国家标准I.S.
- 发布日期:
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a perform
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