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1、H&MHennes&MauritzGBCAB16(16)Identificationofmedicaldevicecharacteristics医疗器械特性的识别RevDateNameCommentA01XXCreatedIdentificationofcharacteristics(ENISO14971:2012)特性识别1Whatistheintendeduseandhowisthemedicaldevicetobeused?医疗器械的预期用途是什么?医疗器械如何使用?Factorsthatshouldbeconsideredi
2、nclude:需要考虑到的因素包括-whatisthemedicaldevice'srolerelativeto-医疗器械所扮演的角色与下列哪个相关-diagnosis,prevention,monitoring,treatmentoralleviationofdisease,-疾病的诊断,预防,监护,治疗或缓解-compensationforinjuryorhandicapor-对创伤或残疾进行补偿-replacementormodificationofanatomy,orcontrolofProductdescription:产
3、品描述Patientgroup:患者群User:使用者Needforeducation?需要教育H&MHennes&MauritzGBCAB16(16)conception?-解剖过程的替代或矫正,或妊娠控制-whataretheindicationsforuse(e.g.patientpopulation)?-使用指示是什么?(如患者群)-doesthemedicaldevicesustainorsupportlife?-医疗器械是否用于生命维持?-isspecialinterventionnecessaryinthecaseof
4、failureofthemedicaldevice?-如果器械失效是否有必要进行特殊的干预Environment:环境Installation?安装2Isthemedicaldeviceintendedtobeimplanted?医疗器械是否预期用于植入Factorsthatshouldbeconsideredincludethelocationofimplantation,thecharacteristicsofthepatientpopulation,age,weight,physicalactivity,theeffectof
5、ageingonimplantperformance,theexpectedlifetimeoftheimplant,thereversibilityoftheimplantation.需要考虑的因素包括植入的位置,患者群的特点、年龄、体重、身体机能,年老对植入性能的影响,植入物的预期寿命,植入物是否可取出YES/NOMotivation/description动机/描述3Isthemedicaldeviceintendedtobeincontactwiththepatientorotherpersons?医疗器械是否预期和患者或其
6、他人接触?Factorsthatshouldbeconsideredincludethenatureoftheintendedcontact,i.e.surfacecontact,invasivecontact,orimplantationand,foreach,theperiodandfrequencyofcontact需要考虑的因素包括预期接触的性质,(即表面接触,有创接触,或者植入),以及每种接触的时间和接触的频次.YES/NOMotivation/description4Whatmaterialsorcomponentsar
7、eutilizedintheH&MHennes&MauritzGBCAB16(16)medicaldeviceorareusedwith,orareincontactwith,themedicaldevice?在医疗器械中用到了何种材料或部件?或何种材料或部件与医疗器械共同使用,或与产品接触Factorsthatshouldbeconsideredinclude:需要考虑的因素-compatibilitywithrelevantsubstances;-与相关物质的兼容性-compatibilitywithtissuesorbodyf
8、luids;-与组织或体液的兼容性-whethercharacteristicsrelevanttosafetyareknown;-与安全相关的特性是否已知-isthedevicemanufacturedutilizingmateri
