★醫(yī)療器械風(fēng)險(xiǎn)管理計(jì)劃標(biāo)準(zhǔn)模板

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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風(fēng)險(xiǎn)管理文檔1目的文檔對(duì) 的全部風(fēng)險(xiǎn)管理活動(dòng)進(jìn)行了記錄，用來證明風(fēng)險(xiǎn)管理的符合性，并為產(chǎn)品設(shè)計(jì)和產(chǎn)品安全性評(píng)估提供相關(guān)的依據(jù)。2規(guī)范性引用下列文件中的條款，通過本文檔相關(guān)條款的引用成為村文檔條款。YY/T 03162003醫(yī)療器械風(fēng)險(xiǎn)管理對(duì)醫(yī)療器械的應(yīng)用注冊(cè)產(chǎn)品標(biāo)準(zhǔn)3產(chǎn)品描述3.1 產(chǎn)品特征a概況（產(chǎn)品類型等的描述）b預(yù)期用途c預(yù)期目的d適用環(huán)境 e產(chǎn)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 產(chǎn)品壽命周期階段4風(fēng)險(xiǎn)管理工

9、作執(zhí)行者簡(jiǎn)介序號(hào)姓名單位職稱主要經(jīng)歷和專長(zhǎng)5風(fēng)險(xiǎn)的可接受性準(zhǔn)則5.1 風(fēng)險(xiǎn)可接受性的決策過程此過程中有三個(gè)決策點(diǎn)，對(duì)風(fēng)險(xiǎn)的可接受性提出不同的問題：a風(fēng)險(xiǎn)是否低到不需要對(duì)它進(jìn)行考慮 ？b是否不再有任何理由去考慮風(fēng)險(xiǎn)，或者風(fēng)險(xiǎn)已降到合理可行的低水平，并且風(fēng)險(xiǎn)已被受益超過 ？c是否所有的風(fēng)險(xiǎn)對(duì)所有受益的全面平衡是可接受的？在有適當(dāng)?shù)臄?shù)據(jù)可資利用的情況下，應(yīng)優(yōu)先考慮對(duì)風(fēng)險(xiǎn)進(jìn)行定量分類。5.2 風(fēng)險(xiǎn)發(fā)生概率水平的分類表示符系數(shù)值風(fēng)險(xiǎn)發(fā)生概率定量分析的范圍概率的定性描述備注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 風(fēng)險(xiǎn)嚴(yán)重度水平的分類表不符系數(shù)

11、值風(fēng)險(xiǎn)嚴(yán)重度定量的描述風(fēng)險(xiǎn)嚴(yán)重度定性的描述備注S1S2S3S4S5S65.4 可接受系數(shù) AcAc = Pi + Si5.5 廣泛可接受區(qū)Ac < ;該區(qū)域內(nèi)，風(fēng)險(xiǎn)是可以接受的，并且不需要主動(dòng)采取風(fēng)險(xiǎn)控制。5.6 ALARP（合理可行）區(qū) < Ac < ;該區(qū)域內(nèi)，應(yīng)先考慮接受風(fēng)險(xiǎn)的受益和進(jìn)一步降低的可行性，然后對(duì)風(fēng)險(xiǎn)與 受益進(jìn)行比較，如果受益超過風(fēng)險(xiǎn)，則風(fēng)險(xiǎn)是可接受的；如果受益沒有超過風(fēng) 險(xiǎn)，則風(fēng)險(xiǎn)是不可接受的。任何風(fēng)險(xiǎn)都應(yīng)降到可行的最低水平。5.7 不容許區(qū)Ac > ;該區(qū)域內(nèi)，風(fēng)險(xiǎn)如果不能予以降低，則判斷為是不容許的。6產(chǎn)品及附件危害清單以下各條款序號(hào)同時(shí)作為后續(xù)

12、風(fēng)險(xiǎn)管理中的產(chǎn)品危害的編號(hào)6.1 產(chǎn)品在疾病的診斷、預(yù)防、監(jiān)護(hù)、治療或緩解，創(chuàng)傷和殘疾的補(bǔ)償，解剖方面的替代或矯正，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 產(chǎn)品是否用于生命維持或生命支持?可能的危害：6.3 在產(chǎn)品失效的情況下是否需要特殊的干預(yù)?可能的危害：6.4 是否有接口設(shè)計(jì)方面的特殊問題，可以導(dǎo)致不經(jīng)心的使用錯(cuò)誤?可能的危害：6.5 產(chǎn)品是否預(yù)期和患者或其他人員接觸?可能的危害：6.6 在產(chǎn)品中包含有何種材料和/或組分或與其共同使用、或與產(chǎn)品接觸?可能的危害：6.7 是否有能量給予患者或從患者身上獲取?可能的危害：6.8 是否有物質(zhì)提供給患者或從患難身上提取?可能的危害：6.9 是否由產(chǎn)品處理生物材料然后再次使用?可能的危害：6.10 產(chǎn)品是否以無菌形式提供或準(zhǔn)備由使用者滅菌，或用其他微生物控制方法滅菌 ?

23、可能的危害：6.11 產(chǎn)品是否預(yù)期由用戶進(jìn)行常規(guī)清潔和消毒?可能的危害：6.12 產(chǎn)品是否預(yù)期改善患者的環(huán)境?可能的危害：6.13 產(chǎn)品是否進(jìn)行測(cè)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 產(chǎn)品是否進(jìn)行分析處理?可能的危害：6.15 產(chǎn)品是否預(yù)期和醫(yī)藥或其它醫(yī)療技術(shù)聯(lián)合使用?可能的危害：6.16 是否有不希望的能量或物質(zhì)輸出?可能的危害：6.17 產(chǎn)品是否對(duì)環(huán)境影響敏感?可能的危害：6.18 產(chǎn)品是否影響環(huán)境?可能的危害：6.19 是否需要維護(hù)和校準(zhǔn)?可能的危害：6.20 產(chǎn)品是否有軟件？可能的危害：6.21 產(chǎn)品是否有儲(chǔ)存壽命限制？可能的危害：6.22 是否有延遲或長(zhǎng)期使用效應(yīng)？可能的危害：6.23 產(chǎn)品承受何種機(jī)械力？可能的危害：6.24 是什么決定產(chǎn)品的壽命？可能的危害：6.25 產(chǎn)品是否預(yù)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