本标准包括由合格人员在一般医疗和患者环境中使用或监督的所有医疗电气设备的基本安全和基本性能要求基线。还包含可靠操作的某些要求，以确保安全。本标准也适用于用于补偿或减轻疾病、伤害或残疾的设备。第二次修订涉及自2005年完成主要文件并于2012年首次修订以来术语和参考文献的变化。

This standard includes baseline of requirements for the basic safety and essential performance of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. Also contains certain requirements for reliable operation to ensure safety. This standard can also be applied to equipment used for compensation or alleviation of disease, injury, or disability. The second amendment addresses changes to terminology and references since the main document was finalized in 2005 and first amended in 2012.