fda医疗器械质量体系手册

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1、FDA医疗器械质量体系手册FDA医疗器械质量体系手册Whenfinisheddevicemanufacturersproducecomponentsspecificallyforuseinmedicaldevicestheyproduce,whetherinthesamebuildingoranotherlocation,suchproductionofcomponentsisconsideredpartofthedevicemanufacturingoperations,andtheproductionshouldcomplywiththeQSregulation.当成

2、品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。Accessorydevices[807.20(a)(5)]suchashemodialysistubingormajordiagnosticxraycomponents,thatarepackaged,labeled,anddistributedseparatelytoahospital,physician,etc.,forhealthrelatedpurposesaresometimesinappropriatelyreferred

3、toascomponents.However,FDAconsidersthemfinisheddevicesbecausetheyaresuitableforuseorcapableoffunctioningandaredistributedforhealth-relatedpurposes;andtheQSregulationappliestotheirmanufacture.Similarly,adeviceorcomponentincludingsoftwarethatissoldasanadditiontoafinishedmedicaldevicetoaugme

4、ntorsupplementitsperformanceisalsotermedanaccessory.Anaccessorytoamedicaldeviceisconsideredafinisheddeviceand,therefore,issubjecttotheQSregulation.附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，FDA认为它们是成品器械因为它们可以使用于或作用于并且销售来为健康相关的目的；并且QS法规要应用Whenfinish

5、eddevicemanufacturersproducecomponentsspecificallyforuseinmedicaldevicestheyproduce,whetherinthesamebuildingoranotherlocation,suchproductionofcomponentsisconsideredpartofthedevicemanufacturingoperations,andtheproductionshouldcomplywiththeQSregulation.当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零

6、件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。Accessorydevices[807.20(a)(5)]suchashemodialysistubingormajordiagnosticxraycomponents,thatarepackaged,labeled,anddistributedseparatelytoahospital,physician,etc.,forhealthrelatedpurposesaresometimesinappropriatelyreferredtoascomponents.However,FDAconsiderst

7、hemfinisheddevicesbecausetheyaresuitableforuseorcapableoffunctioningandaredistributedforhealth-relatedpurposes;andtheQSregulationappliestotheirmanufacture.Similarly,adeviceorcomponentincludingsoftwarethatissoldasanadditiontoafinishedmedicaldevicetoaugmentorsupplemen