IEC 60601-2-54:2009/COR2:2011标准主要适用于X射线设备,包括放射学和透视学设备。该标准规定了这些设备的基本安全和基本性能要求,以确保它们在使用过程中能够保护患者、操作人员和其他人员的安全。
该标准规定了X射线设备的各种参数和性能指标,包括辐射剂量、成像质量、设备的机械结构和电气安全等方面。此外,该标准还规定了设备的标识、标志和使用说明书等方面的要求。
IEC 60601-2-54:2009/COR2:2011标准的实施可以有效地提高X射线设备的安全性和性能,减少患者和操作人员的辐射剂量,提高成像质量,从而提高诊断的准确性和可靠性。
相关标准
- IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-43:2010 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
- IEC 60601-2-11:2015 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
- IEC 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
- IEC 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography