医疗电气设备 - 第2-39部分:腹膜透析设备的基本安全和基本性能的特殊要求

[中文适用范围]： 本部分IEC 60601适用于腹膜透析医疗电气设备（PD设备）的基本安全和主要性能，如201.3.208中所定义。它适用于由医务人员使用或在医学专家监督下使用的PD设备，包括由患者操作的PD设备，无论是在医院还是家庭环境中使用。如果条款或子条款明确仅适用于医疗电气设备（ME设备）或仅适用于医疗电气系统（ME系统），则该条款或子条款的标题和内容将明确说明。否则，该条款或子条款适用于相关的ME设备和ME系统。本文档范围内的医疗电气设备或医疗电气系统固有的生理功能危害，除通用标准中的7.2.13和8.4.1外，本文档中无特定要求。本文档也可应用于用于补偿或缓解疾病、伤害或残疾的PD设备。这些特定要求不适用于透析液或透析液回路。 [外文原描述]： IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: - update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015; - editorial improvements; - improvement of the essential performance requirements clause/subclauses; - new requirements for the interruption of the power supply.