医疗器械汇编2022版-178页_865kb
报告摘要
- Introduction: This is a summary of China's current medical device standards as of 2022, issued by organizations like the National Institutes for Food and Drug Control (NIFDC) and Standardization Technical Committees (STCs), supporting regulatory oversight and industry development.
- Total Standards: There are currently approximately 1851 effective standards.
- Key Categories:
- General medical devices and quality management.
- Quality-related standards (e.g., YY/T Standards).
- Unique identification (UDI) systems.
- Packaging and biological evaluation.
- Elect齐therapy and diagnostic equipment.
- Standardization Committees:
- SAC/TC221: Medical device quality management and standards selection.
- SAC/TC10/SC2: Medical electrical equipment safety.
- SAC/TC136: Clinical laboratory testing performance criteria.
- Implementation: These standards are broadly categorized into areas like 管理领域 (general standards), then subdivided into Specific Fields unique to the device category, ensuring application in quality control and clinical usage.
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