★医疗器械风险管理计划标准模板

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4、obe”. 2, - t he .pe.e n-a-on of -e Le ntra- “ort es of the eght proO ons .pro- ng Hach, .pr oVng . .!-hods but thee ae e - gr roos un-s pr.a, ”. a -，l>eq - e gras of -eQ/企业缩写风险管理文档（本文件在质量体系文件集里的编号）产品名称:产品编号:编制:日期:审批：日期:XXXXXXXXXXXXXXXXiiEt t it gItm l- keto ieettu a- cee eleit a ec a gsj c t e- t

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7、r -s e gf e e d sc - - cdac - tte- ve - at tg- e e e-te- -.- ase-ga - s e-c-vei-s -aeedfr风险管理文档1目的文档对 的全部风险管理活动进行了记录，用来证明风险管理的符合性，并为产品设计和产品安全性评估提供相关的依据。2规范性引用下列文件中的条款，通过本文档相关条款的引用成为村文档条款。YY/T 03162003医疗器械风险管理对医疗器械的应用注册产品标准3产品描述3.1 产品特征a概况（产品类型等的描述）b预期用途c预期目的d适用环境 e产品的使用方法aa id. y5 ya .-.e.m .a. . a

8、c- us c e' cd.-s. e.thi.e-c g .fkg eag -.-Pkt -d st el一 .a e v- .a-.th.ieaea. d ee,T el.focem.to-.“e s l s.- d d ca.-.-.i a - .eay-c.-e.e -ls- c . a-.- c -c w.-.- e. -c -e.e.la- - -d.c-.y-.e.P e a .e.-.e-la.-2- -e a-.aa.-g-s.ea-.c.seal.s.-a.aaaaga.ew-se. e d . -s.e-. a. . . eee3.2 产品寿命周期阶段4风险管理工

9、作执行者简介序号姓名单位职称主要经历和专长5风险的可接受性准则5.1 风险可接受性的决策过程此过程中有三个决策点，对风险的可接受性提出不同的问题：a风险是否低到不需要对它进行考虑 ？b是否不再有任何理由去考虑风险，或者风险已降到合理可行的低水平，并且风险已被受益超过 ？c是否所有的风险对所有受益的全面平衡是可接受的？在有适当的数据可资利用的情况下，应优先考虑对风险进行定量分类。5.2 风险发生概率水平的分类表示符系数值风险发生概率定量分析的范围概率的定性描述备注PlP2P3P4P5P6aa st y5 ya .-. a-acia -e s c- us c. -c.- - em st-s. e.

10、-e-c . -kg eag -.-Pkt -d st elu5ie-a e v- .”.a-.ieaeau d eee.e.focem.-."e s l s.- .-.-.- sr.- -.i - -se- a y-d.-ege-s- c .- a-.- c -.- esc- - - . -c -eaueg- - -d.c- gy-se - e a -e-e- -a-s-.-2- -e a-aa-eg-s. -.c-s e a -ess . as -.- a- aa.s- h -se. e e . sc -s-e- v - a- -.- eee5.3 风险严重度水平的分类表不符系数

11、值风险严重度定量的描述风险严重度定性的描述备注S1S2S3S4S5S65.4 可接受系数 AcAc = Pi + Si5.5 广泛可接受区Ac < ;该区域内，风险是可以接受的，并且不需要主动采取风险控制。5.6 ALARP（合理可行）区 < Ac < ;该区域内，应先考虑接受风险的受益和进一步降低的可行性，然后对风险与 受益进行比较，如果受益超过风险，则风险是可接受的；如果受益没有超过风 险，则风险是不可接受的。任何风险都应降到可行的最低水平。5.7 不容许区Ac > ;该区域内，风险如果不能予以降低，则判断为是不容许的。6产品及附件危害清单以下各条款序号同时作为后续

12、风险管理中的产品危害的编号6.1 产品在疾病的诊断、预防、监护、治疗或缓解，创伤和残疾的补偿，解剖方面的替代或矫正，妊娠的控制等方面起什么作用？可能的危害：tWhheeprinnctihpelre aereofsusibmstpalinftiieadliEssues,sIeAofconstruccttioornleparders arroajnecgtedstin the regoipersoonn.alInterlmyisntoefrlvaene,innd,li -npkeerdtosotnh,eiinm-ppelresmoenntatipushtangi on ofbluerarebaan

13、 bauilnddrinugraalcgorenestrucntiloinghlta,nedasinyclireasenae. Tofurtherrneddudceecarea se,rnepdlsatcaenmdeardi ntziendaidcamtionrisstfroartive exapmriionarittiyonaraeas projendcta.Cphparrgeso,vial itemnst,ostihmeplifyperxojaemincattis ofwater,on aenldecatpriprovaclitlyi,a dmniknsis,tirmatpirvechoa

14、vergeefsficainedncpyr;efaecrceonrtdiailpoli ng tothe . cies.Inthe area oftaxation,andsettled in areas ofindustry and its productioncompany,withi n 5yearsafterthe completionoffiscalincentives toenterpri ses.Interms offinancing, integrationofland,tax,financial andotherresources,and construct"Gove

15、rnment cre dit +busine sscredit" creditsystem,establishme nt ofmarketization,commercialization andmodernizati on ofthe investment a ndfina nci ng platform;effectiveBank-enterprisedocki ng, encouragesprivate capitali ntothe Park,toraiseindustry devel opme ntfund.5,optimizethe environmentand serv

16、i ceindustries.To create "poli cylow lands, Hig hlands,i ntegrityofservice land,developme nt land"as thegoal,t ooptimizethe area under developme ntenvironment.Alladministrative lawe nforceme ntdepartme ntstoa ppoint afull-timepersonnelstationed i n areas dedicate dto coor dinating and solv

17、i ng problems associate d withbusinesses i n this sector.Sincethe educati onal practice ofthe massline ofthe party,himselfseriouslyin thee ducation,pra ctical contr olce ntral" eight rules" a ndopposi ng"the fourwi nds"a nd pra ctici ng "threeSuns", andcheckthe spiritof

18、Jiao Yul u, ide ology,solicit opinionsba sed on outstanding probl emschecke d swi ng,carefula nalysi sand reflection. Willnow che ckreportis asfollows:first, adhere ncet othe party' spol iticaldi sci pline, eight i nthe centralprovi sion, changethestyleofthe basi csituati on of1, incomplia nce w

19、iththe party's politicaldiscipli nes.Conscie ntiously a bide bythe party's politi cal disci pline,abi debyt heConstituti on a ndtherule sand regulationsofthe party,in the politi cal,ideol ogicala nd maintai n hig hly consi stentwith t he CPC Cent ralCommittee on theaction,ther eis noviolati

20、onofthe party's political discipli ne pr oblems.2,in t heimpleme ntation ofthe ce ntralauthoritiesofthe eight provisi ons.Improvi ng resear ch, impr oving researchmethods,butthere arele ss grass -roots units,primaryfirst-hand an inade quategrasp oftheprobl em,whi ch ist obestre ngthened i nthefu

21、t ure.Second, construction,stri ctlyin accordance with thepr ovisi onst o streamline a nd improve thequality ofmeetings ofthe Conference.Third, streamli ningfile bri efs,cult ureinv olvesallaspect sof propaganda andide olog y,sometimes duetothe pra ctical needsof inve ntion notificati ons, thisarea

22、needs further6.2 产品是否用于生命维持或生命支持?可能的危害：6.3 在产品失效的情况下是否需要特殊的干预?可能的危害：6.4 是否有接口设计方面的特殊问题，可以导致不经心的使用错误?可能的危害：6.5 产品是否预期和患者或其他人员接触?可能的危害：6.6 在产品中包含有何种材料和/或组分或与其共同使用、或与产品接触?可能的危害：6.7 是否有能量给予患者或从患者身上获取?可能的危害：6.8 是否有物质提供给患者或从患难身上提取?可能的危害：6.9 是否由产品处理生物材料然后再次使用?可能的危害：6.10 产品是否以无菌形式提供或准备由使用者灭菌，或用其他微生物控制方法灭菌 ?

23、可能的危害：6.11 产品是否预期由用户进行常规清洁和消毒?可能的危害：6.12 产品是否预期改善患者的环境?可能的危害：6.13 产品是否进行测量?treamlining.Fourare standardvisits,exce pt asrequiredtopartici pate in training,noot heractivity. Five ist o improvenews reporti ng, for propagandaworkstrictlyaccor ding to the regulations. Sixis strictlyyour presentationpubl

24、i shedstrictlya ccordingt o theregu lations.Sevenis strictly thrift, requiredthe useofvehicles andofficespace andcorporate hospitality.3, changet hestyle.Propaganda and ideologica lworkofthe newsituationand new requirements ofthe new tasks,ha d done al otoffruitfulwork,has made many achievements,but

25、furt herclosertot hegrass roots,closetoreality,closetothe massesa nd al soi nadequate i nnovationm ustcontinueto im prove.Se cond,the"fourwinds"some outstandi ng issues1,oppose formalism.One theory isthat he didn't,with le ssclose contact.T heoreti calstudyofconsciousness i s nothigh e

26、 nough,system performanceis notstrongenough;more passivel earni ng, active learni ngfewgeneralities a nd lear n more, delving i nto less.Especially based on rationalthinking onmajori ssue s,applyingt heory to g uide thew orkdoneis notgood e nough, notreally understandand graspthespirit ande ssence o

27、fthescientificOutlookon devel opme nt,di dnottrulyachievemastery,toapply,to acertain extent,affectthedevelopmentand implementationofidea sand initiatives. Second,work arrangements, and less supervision. Propaga nda a nd ide ologicalwork ist heobje ctive,which needs tokee p the continuity effortsdepl

28、 oyed, butstressed in thew ork time, less supe rvision.Forexample,colorweeke nds inthe summertheatricalactivities,city square performa nces, urgi ng townshi ps,communitiesand ruralareas showst he impleme ntation i sina dequate, insufficie ntcultural an e ducationalrole t opla y.Thir d ba seenoug h,m

29、astergrass -less real. Pr opaganda and ideol ogicalworkint hene wsituati on ofchara cteristics andregularity of enough, deep enough for grass-r oots public opi nion Dynami cs survey,forgrass-rootstypically drive less. Forexam ple,rural cult ureteam active,.I'm notactively takethe initiativetotak

30、e up,the lackofspiritofdari ngto, resulti ng in somejobhada lotofpowe r,but notangi ble result s.Thir d,innovati on,la ckofmotivation. Emancipation didnotend, innovati on does not exist.In practicalw ork,notyour head, previousw orkexperie nce, lack ofinnovationinitiatives, study on thecharacteristi

31、csof propaga nda andi deol ogicalw orkundert he newsituationthroug h, grip on grassr oots i deol ogicaltre ndsa nd changes arenotdeep,to promote new initiative sand explore new methodsofide ologicaland culturalwork isnot much,a nd some la ckofrelevance andtimeliness.4, discipli ne,lowering,a nd hard

32、 workare lacki ng.Whileworking a nde nterprisi ng spiritdown. No real sol ution t o treatyourself right, corre ctly treat past honors,their compla ce ncy,andworktoseetheirscore smore,lesschecki ng his ow n shortcomi ngs,liketoli stentothe praise ,satisfied face ,online promoti on,there aretypical, a

33、ndlackofhighstandardsand strictrequirements,theeffect isreal.Secondhard drive less.Onhar d andtWheheprinnctihpelre aereofsusibmstpalinftiieadliEssues,sIeAofconstruccttioornleparders arroajnecgtedstin the regoipersoonn.aIlnterlmyisntoefrlvaene,innd,li -npkeerdtosotnh,eiinm-ppelresmoenntatipushtangi o

34、n ofbluerarebaan bauilnddrinugraalcgorenestrucntiloignhlta,nedasinyclireasenae. Tofurtherrneddudceecarea se,rnepdlastcaenmdeardi nt iznedaidcamtionrisstfroartive exapmriinoarittiyonaraeas projendcta.Cphparrgoevsa,liitems,nstiomthpleify expraomjeinaticts ofwater,on aenldecatpri pcirtoyv,aallidmniknsi

35、s,tirmatpirvechoavergeefsficainedncpyr;efaecrceonrtdiailpoli ng tothe . cies.Inthe areaoftaxation,andsettled in areas ofindustry and its productioncompany,within 5yearsafterthe completionoffiscalincentives toenterpri ses.In termsoffinancing,integration ofland,tax,financialand otherresources, andcons

36、truct"Government cre dit +busine sscred it"credit system,esta blishme nt ofmarketization,commercialization andmodernizati on ofthe investment andfina nci ng platform;ef fective Bank-enterpri sedocki ng, encouragesprivatecapitali ntothe Park,toraiseindustry devel opme ntfund.5,optimizethe e

37、nvironmentand servi ceindustries.To create "poli cylow lands, Hig hlands,integrityofservice land,developme nt land"as thegoal,t ooptimizethe area under developme ntenvironment.Alladministrative lawe nforcementdepartmentstoa ppoint afull-timepersonnelstationed i n areas de dicate dto coor d

38、inating and solvi ng problems associate d withbusinesses i n this sector.Sincethe educati onal practice ofthe massline ofthe party,himselfseriouslyin thee ducation,pra ctical contr olce ntral"eightrules"a ndopposi ng"the fourwi nds"a nd pra ctici ng "threeSuns", andchec

39、kthe spiritofJiao Yul u, ide ology,solicit opinionsba sed on outstanding probl emschecke d swi ng,carefula nalysi sand reflection.Will now che ckreportis asfollows:first, adhere ncet othe party'spol iticaldisci pline, eight i nthe centralprovi sion, changet hestyleofthe basi csituati on of1, inc

40、omplia nce withthe party's political discipli nes.Conscie ntiously a bide bythe party's politi cal disci pline,abi debyt heConstituti on and t herule sand regulationsofthe party,in the politi cal,ideol ogicaland maintai n hig hly consi stentwith t he CPC CentralCommittee on theaction,thereis

41、 noviolati onofthe party's political discipli ne pr oblems.2,in t heimpleme ntation ofthe ce ntralauthoritiesofthe eight provisi ons.Improvi ng research, impr oving researchmet hods,butthere arele ss grass -roots units,primaryfirst-hand an inade quategrasp oftheprobl em,whi ch ist obestrengthene

42、d inthe fut ure.Second, construction,stri ctlyin a ccordance wit h thepr ovisi onst o streamline a nd improve thequality ofmeetings ofthe Conference.Third, streamli ningfile bri efs,cult ureinv olvesallaspect sof propaganda andide olog y,som etimes duetothe pra ctical needsof inve ntion notificati o

43、ns, thisarea needs further可能的危害：6.14 产品是否进行分析处理?可能的危害：6.15 产品是否预期和医药或其它医疗技术联合使用?可能的危害：6.16 是否有不希望的能量或物质输出?可能的危害：6.17 产品是否对环境影响敏感?可能的危害：6.18 产品是否影响环境?可能的危害：6.19 是否需要维护和校准?可能的危害：6.20 产品是否有软件？可能的危害：6.21 产品是否有储存寿命限制？可能的危害：6.22 是否有延迟或长期使用效应？可能的危害：6.23 产品承受何种机械力？可能的危害：6.24 是什么决定产品的寿命？可能的危害：6.25 产品是否预期一次性使

44、用？treamlining.Fourare standardvisits,exce pt asrequiredt opartici pate in training, noot heractivit y. Five ist o improvenews re porti ng, for propagandaworkstrictlyaccor ding to the regulati ons. Sixis strictlyyour presentationpublishedstrictlya ccordingt o theregulations.Sevenis strictly thrift, r

45、equiredthe useofvehicles andofficespace andcorporate hospitality.3, changet hestyle.Propaganda a nd ideol ogica lworkofthe newsituationand ne w requirements ofthe new tasks,ha d done al otoffruitfulwork,has made ma ny achievements, butfurt herclosertot hegrass roots,closetoreality,closetothe massesa

46、 nd al soi nade quate i nnovationm ustcontinueto im prove.Se cond,the"fourwinds"some outstandi ng issues1,oppose formalism.One theory ist hat he didn't,with lessclose contact.T heoreticalstudy of consciousness i s not high e nough,sy stem performance is notstrongenoug h;more passivel e

47、arni ng, active le arni ngfewgeneralities a nd lear n more, delving i nto less.Especially based on rationalthinking onmajorissue s,applyingt heory to g uide thew orkdoneis notgood e nough, notreally understandand graspthespirit ande ssence ofthescientific Outlookon devel opme nt,di dnottrulyachievem

48、astery,toapply,to acertain extent,affectthedevelopmenta nd impl ementationofidea sand initiatives.Second,work arrangements, a nd less supervision. Propaga nda a nd ideologicalwork ist heobje ctive,whichneeds tokeep the continuity efforts depl oyed, butstressed i n thew ork time, less supe rvision.Fo

49、rexample,colorweeke nds inthe summertheatricalactivities, city square performances, urgi ng townshi ps,communitiesand ruralareas showst he impleme ntation i sina dequate, insufficie ntcultural an e ducationalrole t opla y.Thir d ba seenoug h,mastergrass -less real. Pr opaganda and ideol ogicalw orki

50、nt hene wsituati on ofchara cteristics andregularity of enough, deep enough for grass-r oots public opi nion Dynami cs survey,forgrass-rootstypically drive le ss. Forexam ple,rural cultureteam active,.I'm notactively takethe i nitiativetotake up,the lackofspiritofdari ngto, resulti ng in somejob

51、ha da lotof powe r,but notangi ble result s.Thir d,innovati on,la ckofmotivation. Emancipation didnotend, innovation does not exist.In practicalw ork,notyour head, previousw orkexperie nce, lack ofinnovationi nitiatives,study on thecharacteristi csof pr opaga nda andi deol ogicalw orkundert he newsi

52、tuati onthroug h, grip on grassroots i deol ogicaltre ndsa nd changes are notde ep,to promote new initiativesand explorenew methodsofide ologicaland culturalwork isnot much,a nd some la ckofrelevance andtimeliness.4, discipli ne,lowering,and hard workare lacki ng.Whilew orking a nde nterprisi ng spiritdown.No realsol ution t o treatyourself right,corre ctlytreat pasthonor s,theircompla ce ncy,andworktoseetheirscore smore,lesschecking his ow n shortcomi ngs,liketoli stento the praise,satisfied face,online promoti o