标准号:BS EN 60601-2-57-2011
中文标准名称:医疗电气设备.用于治疗,诊断,监控和化妆/美学的非激光源设备的基本安全性和必要性能的特定要求
英文标准名称:Medical electrical equipment. Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
标准类型:C39
发布日期:2011/6/30 12:00:00
实施日期:2011/6/30 12:00:00
中国标准分类号:C39
国际标准分类号:11.040.50;11.040.60
引用标准:IEC 60947-3;IEC 62471;ISO 3864-2
适用范围:Replacement:This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipmentincorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiologicaleffects in humans or animals for therapeutic, diagnostic, monitoring,cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment(LS EQUIPMENT).This particular standard does not apply to equipment for sun tanning, for ophthalmicinstruments or for infant phototherapy.LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or withoutpower supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.