fda医疗器械质量体系手册

《fda医疗器械质量体系手册》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

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,andtheproductionshouldcomplywiththeQSregu

2、lation.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.,forhealthrelatedpurposesaresometimesinapp

3、ropriatelyreferredtoascomponents.However,FDAconsidersthemfinisheddevicesbecausetheyaresuitableforuseorcapableoffunctioningandaredistributedforhealth-relatedpurposes;andtheQSregulationappliestotheirmanufacture.Similarly,adeviceorcomponentincludingsoftwarethatissoldasanadditiontoaf

4、inishedmedicaldevicetoaugmentorsupplementitsperformanceisalsotermedanaccessory.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

5、作用于并且销售来为健康相关的目的；并且QS法规要应用Whenfinisheddevicemanufacturersproducecomponentsspecificallyforuseinmedicaldevicestheyproduce,whetherinthesamebuildingoranotherlocation,suchproductionofcomponentsisconsideredpartofthedevicemanufacturingoperations,andtheproductionshouldcomplywiththeQSregu

6、lation.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.,forhealthrelatedpurposesaresometimesinapp

7、ropriatelyreferredtoascomponents.However,FDAconsidersthemfinisheddevicesbecausetheyaresuitableforuseorcapableoffunctioningandaredistributedforhealth-relatedpurposes;andtheQSregulationappliestotheirmanufacture.Similarly,adeviceorcomponentincludingsoftwarethatissoldasanadditiontoaf

8、inishedmedicaldevicetoaugmentorsupplemen