BS EN 61010-2-101-2002 测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求

标准号：BS EN 61010-2-101-2002
中文标准名称：测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求
英文标准名称：Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment
标准类型：N20
发布日期：2002/12/9 12:00:00
实施日期：2002/12/9 12:00:00
中国标准分类号：N20
国际标准分类号：11.100.10
适用范围：Replacement:This part 2 applies to equipment intended for in vitro diagnostic (IVD) medical purposes,including self-test IVD medical purposes.IVD medical equipment, whether used alone or in combination, is intended by themanufacturer to be used in vitro for the examination of specimens, including blood and tissuesamples, derived from the human body, solely or principally for the purpose of providinginformation concerning one or more of the following: a physiological or pathological state; or a congenital abnormality; the determination of safety and compatibility with potential recipients; the monitoring of therapeutic measures.Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in ahome environment.NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 aswell as within the scope of this standard, it will also need to meet the requirements of those other part 2 standards.