标准摘要
[中文适用范围]： 本国际标准适用于旨在由制造商在使用说明中指明用于急救医疗服务环境（EMS 环境）的医疗设备（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生病的患者的紧急响应、生命支持以及在继续此类生命支持的同时将患者转运至适当的职业医疗保健机构进行进一步护理；以及在职业医疗保健机构之间转运期间提供监测、治疗或诊断。本标准不适用于仅旨在用于家庭保健环境（由 IEC 60601-1-11 涵盖）或仅用于职业医疗保健设施（由 IEC 60601-1 涵盖，且无 IEC 60601-1-11 或本附属标准的补充）的 ME 设备和 ME 系统。ME 设备和系统通常不专为单一环境设计，如果它们也旨在用于 EMS 环境，则属于本标准的范围。 [外文原描述]： IEC 60601-1-12:2014+A1:2020 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. This consolidated version consists of the first edition (2014) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment