PREN 13975-2002 标准详情
- 标准号:PREN 13975-2002
- 中文标题:采样过程中使用的验收测试体外诊断医疗设备 - 统计方面
- 英文标题:Sampling Procedures Used For Acceptance Testing Of In Vitro Diagnostic Medical Devices - Statistical Aspects
- 标准类别:欧盟标准EN
- 发布日期:
Defines sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Also defines requirements and criteria for testing procedures to establish and verify th
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