IEC 60601-1-3:2008/AMD2:2021
Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
发布时间:2021-01-26 实施时间:


IEC 60601-1-3:2008/AMD2:2021标准规定了医用电气设备在设计、制造和使用过程中必须遵守的辐射防护要求。该标准要求医用电气设备必须具备以下特点:

1. 辐射剂量监测:医用电气设备必须配备辐射剂量监测系统,能够实时监测患者、操作人员和其他人员的辐射剂量,并能够及时报警。

2. 辐射剂量限制:医用电气设备必须限制患者、操作人员和其他人员的辐射剂量,确保其不会超过安全限值。

3. 辐射剂量记录:医用电气设备必须能够记录患者、操作人员和其他人员的辐射剂量,以便于后续的辐射剂量评估和管理。

4. 辐射剂量报告:医用电气设备必须能够生成辐射剂量报告,向患者、操作人员和其他人员提供辐射剂量信息。

5. 辐射剂量优化:医用电气设备必须优化辐射剂量,尽可能减少患者、操作人员和其他人员的辐射剂量。

6. 辐射剂量培训:医用电气设备的操作人员必须接受辐射剂量培训,了解辐射防护知识和操作规程。

IEC 60601-1-3:2008/AMD2:2021标准的实施可以有效保护患者、操作人员和其他人员的健康安全,减少辐射剂量对人体造成的损害。

相关标准
- IEC 60601-1:2005/AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-43:2010 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
- IEC 60601-2-54:2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-2-63:2012 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment