Addition: This Particular Standard details the requirements to be applied to SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS as defined in 2.101 to 2.105, hereinafter referred to as EQUIPMENT. This standard does not apply to - headlights, - endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18, - luminaires used in dentistry, which are covered by ISO 9680, - luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4, - luminaires of an emergency lighting, which are covered by IEC 60598-2-22. NOTE Luminaires used in clinical areas of hospitals other than those defined in 2.101 to 2.105 are covered by IEC 60598-2-25.
IEC 60601-2-41:2000由国际电工委员会 IX-IEC 发布于 2000-02,并于 2009-09-29 实施。
IEC 60601-2-41:2000 在中国标准分类中归属于: C39 医用电子仪器设备,在国际标准分类中归属于: 11.040.30 外科器械和材料,11.040.55 诊断设备,29.140.40 照明设备。
知识点:IEC 60601-1对应的国内标准GB9706.1是医疗器械产品从设计开发、风险评估、标准制定、注册检测等过程实现的重要强制标准。GB9706.1标准导读:《医用电气设备》的安全系列标准由两部分构成:—第1部分:安全通用要求;—第2部分:安全专用要求。...
GB 9706.1-2007/ IEC 60601-1: 医用电气设备 第1 部分:安全通用要求YY0607-2007/ IEC 60601-2-10:1987:医用电气设备 第2 部分:神经和肌肉刺激器安全专用要求GB 4824-2013/ IEC/CISPR 11:2010:工业、科学和医疗(ISM)射频设备电磁骚扰特性 限值和测量方法YY 0505-2012 / IEC 60601-1-2:医用电气设备...
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