標(biāo)準(zhǔn)號(hào)：BS EN 61010-2-101-2002
中文標(biāo)準(zhǔn)名稱：測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求.實(shí)驗(yàn)室診斷(IVD)醫(yī)療設(shè)備的特殊要求
英文標(biāo)準(zhǔn)名稱：Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment
標(biāo)準(zhǔn)類型：N20
發(fā)布日期：2002/12/9 12:00:00
實(shí)施日期：2002/12/9 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：N20
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.100.10
適用范圍：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.