BS EN 60601-2-50-2009 医用电气设备.婴儿光疗设备基本安全性和基本性能的详细要求
【英文标准名称】: Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant phototherapy equipment 【原文标准名称】: 医用电气设备.婴儿光疗设备基本安全性和基本性能的详细要求 【标准号】: BS EN 60601-2-50-2009 【标准状态】: 现行 【国别】: 英国 【发布日期】: 2009-07-31 【实施或试行日期】: 2009-07-31【发布单位】: 英国标准学会(GB-BSI)【起草单位】: BSI【标准类型】: ()【标准水平】: ()【中文主题词】: 婴儿;儿童;定义(术语);电气器具;电气工程;医用电气设备;使用说明书;辐照器;医疗设备;医学科学;医疗技术学;光线疗法;安全性;安全性要求;规范(验收);治疗设备【英文主题词】: Babies;Children;Definitions;Electric appliances;Electrical engineering;Electrical medical equipment;Instructions for use;Irradiation apparatus;Medical equipment;Medical sciences;Medical technology;Phototherapy;Safety;Safety requirements;Specification (approval);Therapy equipment【摘要】: Clause 1 of the general standard applies, except as follows:Replacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANTPHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME EQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,but alternate methods of compliance with a specific clause by demonstrating equivalent safetywill not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISKMANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of anacceptable level when weighed against the benefit of treatment from the device.This particular standard does not apply to:– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information see IEC 80601-2-35;– INFANT INCUBATORS; for information see IEC 60601-2-19;– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;– INFANT RADIANT WARMERS; for information see IEC 60601-2-21.【中国标准分类号】: C47【国际标准分类号】: 11_040_60【页数】: 34P.;A4【正文语种】: 英语
怎么没有附件啊？ 谢谢共享，我要瞅瞅:lol:lol:lol:lol:lol:lol:lol:lol:lol
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