BS EN ISO 18778-2009 呼吸设备.婴儿监视器.详细要求(ISO 18778-2005)

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                   【英文标准名称】:     Respiratory equipment - Infant monitors - Particular requirements(ISO 18778:2005)            【原文标准名称】:     呼吸设备.婴儿监视器.详细要求(ISO 18778-2005)            【标准号】:     BS EN ISO 18778-2009            【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】: 事故预防;呼吸设备;儿童;防护等级;分类;分类系统;控制仪器;生命危险;定义(术语);设计;测定;尺寸规格;接地导线;电气器具;电接触保护;电气设备;医用电气设备;电气保护设备;电气安全性;电磁兼容性;电医学;环境条件;设备;设备安全性;特点;防火;防火安全性;医院设备;批注;检验;救生设备;作标记;测量;机械安全性;医疗器械;医疗设备;医学科学;医疗技术学;监视装置;职业安全;防电击;救护服务;安全性;安全装置;安全性工程;安全规则;安全性要求;规范(验收);监督(认可);试验环境;试验设备;测试;测试条件【英文主题词】: Accident prevention;Breathing equipment;Children;Classes of protection;Classification;Classification systems;Control instruments;Danger to life;Definitions;Design;Determinations;Dimensions;Earth conductors;Electric appliances;Electric contact protection;Electrical equipment;Electrical medical equipment;Electrical protection equipment;Electrical safety;Electromagnetic compatibility;Electromedicine;Environmental conditions;Equipment;Equipment safety;Features;Fire prevention;Fire safety;Hospital equipment;Inscription;Inspection;Life-saving equipment;Marking;Measurement;Mechanical safety;Medical devices;Medical equipment;Medical sciences;Medical technology;Monitoring device;Occupational safetyrotection against electric shocks;Rescue and ambulance services;Safety;Safety devices;Safety engineering;Safety regulations;Safety requirements;Specification (approval);Surveillance (approval);Test atmospheres;Test equipment;Testing;Testing conditions【摘要】: IEC 60601-1:1988, Clause 1, applies except as follows:Amendments (add at end of 1.1):1.1This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.This International Standard does not apply to monitors intended for use in health care facilities/institutions.The requirements of this International Standard, which replace or modify the requirements ofIEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over thecorresponding general requirements.1.4Addition:NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.【中国标准分类号】: C47【国际标准分类号】: 11_040_10【页数】: 38P.;A4【正文语种】: 英语