ISO 11197:2019 医用供电装置

标准编号：ISO 11197:2019

中文名称：医用供电装置

英文名称：Medical supply units

发布日期：2019-11

标准范围

IEC 60601-1:20 05+A1:2012,1.1替换为:本文件适用于医疗供应装置（以下也称为ME设备）的基本安全和基本性能。本文件适用于在工厂内制造或现场组装的医疗用品单元，包括橱柜和其他包含患者护理服务的外壳。注1:在现场将用于患者护理服务的各种部件组装到外壳中的一方被视为医疗用品单元的制造商。除IEC 60601-1:20 05+A1:2012、7.2.13和8.4.1（见201.1.4）中的规定外，本标准中的具体要求未涵盖本文件范围内的ME设备或ME系统预期功能中固有的危害。注2参考IEC 60601-1:20 05+A1:2012,4.2。

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

标准预览图