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现行 IEC 60601-1-12:2014
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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 used in the emergency medical services environment 医用电气设备第1-12部分:基本安全和基本性能的一般要求附属标准:应急医疗服务环境中使用的医用电气设备和医用电气系统的要求
发布日期: 2015-11-18
IEC 60601-1-12:2014是IEC 60601-1《医用电气设备第1部分:基本安全和基本性能的一般要求》(以下简称IEC 60601-1)的附属标准 一般标准。医疗实践越来越多地使用医用电气设备和医用电气系统来监测、治疗或诊断急诊医疗服务环境中的患者。在这种不受控制的恶劣环境中,医疗电气设备的安全令人担忧。这一附带标准是由临床医生、工程师和监管机构共同制定的。本附属标准的术语、要求、一般建议和指南旨在对医用电气设备和医用电气系统的制造商以及负责制定特定标准的技术委员会有用。 本国际标准适用于医用电气设备和医用电气系统(以下简称医用电气设备和医用电气系统)的基本安全和基本性能,如制造商使用说明所示,医用电气设备和医用电气系统拟用于EMS环境(紧急医疗服务环境)。本附带标准的目的是提供医用电气设备和医用电气的一般要求 在环境条件与室内条件不同的情况下,携带到紧急情况现场并在现场使用的系统,以及在运输中使用的系统。本附带标准的目的是规定除通用标准外的一般要求,并作为特定标准的基础。
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.
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归口单位: ISO/TC 121/SC 3
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