医疗电气设备. 第1-12部分: 基本安全和基本性能的一般要求. 副标准: 预期供紧急医疗服务环境下使用的医疗电气设备和医疗电气系统要求

[中文适用范围]： 本国际标准适用于由制造商在说明书中指定的、用于急救医疗服务环境（EMS环境）的医疗电气设备（ME设备）和医疗电气系统（ME系统）的基本安全和基本性能。EMS环境包括在院前环境中对受伤或患病的患者进行响应和提供生命支持，并在继续生命支持的同时将患者转运至合适的专业医疗机构；以及在专业医疗机构之间转运过程中提供监测、治疗或诊断。本标准不适用于仅用于家庭护理环境（IEC 60601-1-11覆盖）或仅用于专业医疗机构环境（IEC 60601-1覆盖）的ME设备和系统。如果ME设备或系统设计用于多种环境，其中包括EMS环境，则其适用本标准的范围。 [外文原描述]： IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.