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1、ICS11.040.60C41中華人民共和國醫(yī)藥行業(yè)標(biāo)準(zhǔn)YY/T1090-2004代替YY91090-1999超聲理療設(shè)備Ultrasonicphysiotherapysystem(IEC61689:1996,Ultrasonics-Physiotherapysystem-Performancerequirementsandmethodsofmeasurementinthefrequencyrange0.5MHzto5MHz,MOD)2004-10-10發(fā)布2005-09-01實施國家食品藥品監(jiān)督管理局發(fā)布YY/T1090-2004目次前言···········。,
2、······················。·······················,······················································??工1范圍····,·················,,,1?!ぁぁぁぁぁぁぁぁぁぁぁぁ?,,·······,,··。】·····,甲,·】····,,,·,········,,,······一12規(guī)范性引用文件············,··················································,··········‘···
3、··················??13術(shù)語和定義···········,··························································································??14符號表····............................................................................................................65基本參數(shù)································
4、········································································??76要求········,,··············,······,,············,·······························································。··?87測量條件和試驗設(shè)備·············································,···········,··························
5、····??98試驗方法··············‘,·························································································??109檢驗規(guī)則···············,,·················,,,········,,················-···,···111················,,?!ひ?410標(biāo)志、包裝························································
6、·············································??14附錄A(規(guī)范性附錄)柵格式掃查測量和分析方法···········································,,········一16附錄B(規(guī)范性附錄)徑向或直線掃查MI1量和分析方法············,·····························??18附錄c(資料性附錄)不確定度的確定導(dǎo)則····························································??20附錄D(
7、規(guī)范性附錄)安全·························?!?,,,,·······,,,,,······,,,,·········,,·······,,·······。一21YY/T1090-2004月1J舀本標(biāo)準(zhǔn)的6.1和6.4為推薦性的,其余為強制性的。本標(biāo)準(zhǔn)與IEC61689;1996(超聲—理療系統(tǒng)—輸出特性的側(cè)量和公布》的一致性程度為修改采用,修改的主要內(nèi)容包括:1標(biāo)準(zhǔn)題目原標(biāo)準(zhǔn)題目采用三段式結(jié)構(gòu),實質(zhì)上包含我國產(chǎn)品標(biāo)準(zhǔn)的規(guī)范性技術(shù)要素—要求和試驗方法,由于修改采用為我國醫(yī)療器械產(chǎn)品標(biāo)準(zhǔn),此外參考IEC60601-2-5:2000(代替IEC