ISO 14155-2011 标准详情
- 标准号:ISO 14155-2011
- 中文标题:用于人体的医疗器械临床研究. 良好的临床实践
- 英文标题:clinical investigation of medical devices for human subjects -- good clinical practice
- 标准类别:国际标准化组织标准ISO
- 发布日期:2011-01-21
ISO 14155:2011 ADDRESSES GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL INVESTIGATIONS CARRIED OUT IN HUMAN SUBJECTS TO ASSESS THE SAFETY OR PERFORMANCE OF MEDICAL DEVICES FOR REGULATORY PURPOSES. THE PRINCIPLES S
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