IEC 60601-2-39:2018 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
标准编号：IEC 60601-2-39:2018
中文名称：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
英文名称：Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
发布日期：2018-04-06
标准范围
新的！IEC 60601-2-39:2018作为IEC 60601-2-39:2018 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-39:2018适用于腹膜透析医用电气设备的基本安全和基本性能。它适用于供医务人员使用或在医学专家监督下使用的腹膜透析设备，包括由患者操作的腹膜透析设备，无论腹膜透析设备是在医院还是在家庭环境中使用。第三版取消并取代了IEC 60601-2-39的第二版。它构成技术修订。与上一版相比，此版本包括以下重大技术变更:-更新IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012的参考文献、IEC 60601-1-2:20 14的参考文献和要求、IEC 60601-1-6:20 10和IEC 60601-1-6:20 0/AMD1:2013的参考文献和要求、IEC 60601-1-8:20 06和IEC 60601-1-8:20 06/AMD1:2012的参考文献和要求以及IEC 60601-1-11:20 15的参考文献和要求；-编辑方面的改进；-改进基本性能要求条款/子条款；-电源中断的新要求。
NEW!IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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.
标准预览图
