標準號:IEC 60601-2-37-2007
中文標準名稱:醫(yī)療電氣設備.第2-37部分:超聲波醫(yī)療診斷和監(jiān)測設備的基本安全和基本性能用特殊要求
英文標準名稱:Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
標準類型:C41
發(fā)布日期:1999/12/31 12:00:00
實施日期:1999/12/31 12:00:00
中國標準分類號:C41
國際標準分類號:11.040.55;17.140.50
引用標準:IEC 62359
適用范圍:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as MEEQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, 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 SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 of this standard.NOTE See also subclause 4.2 of this standard.This particular standard does not cover ultrasonic therapeutic equipment. Equipment used forthe imaging or diagnosis of body structures by ultrasound in conjunction with other medicalprocedures is covered.
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