1、the pri ncpileofsim plified EIA of construction pr oje cts in t he region. Intermsofland,linked t othe im plementati on ofurba n andrural construction landincreaseand decrease ,repla cementi ndi catorsfor priorityarea s pr oject.Charges, int othe proje cts ofwater,ele ctricity,admi nistrative charge

2、s and preferentialpolici es. Inthe areaoftaxation,andsettled inarea s ofindustry anditspr oduction compa ny,wit hin 5years after the complet ionoffiscali ncentives t oenter prises.In termsoffinancing, integrationof la nd, tax,fina nci al andot her resource s,a nd construct"Governme nt cre dit+b

3、usinesscre dit"credit system, establi shment ofmarketization,commercialization a ndmodernization ofthe i nvestment a ndfi nancing platform;effective Ba nk-e nterprise docki ng, e ncourages private ca pitalintothe Park,toraiseindustrydevelopment fund.5,optimize theenvironment a nd service indust

4、ries. o create "pol icy lowlands, Highla nds, integrity ofservice land, dev elopmentla nd"as thegoal,t o optimizethe areaunder devel opme ntenvironment.Al ladmini strative lawenfor cement departme ntstoa ppoint afull -timepersonne lstationed i n areas dedicatedt ocoor dinati ng andsolvi ng

5、 problems a ssociatedwit hbusinesse sinthi ssect or. Whe n thereare substantial issue s,se ctorleaders arrange d to per sonallyintervene,in-per son,in-per son pushtang ible area buil ding agre en light,ea syline. Tofurt herreduce a ndsta ndar dizeadmi nistrativeexaminationand approvalitems,simplifye

6、xaminationa nd approvalli nks, impr oveefficiency;accor dingtot he.Since theeducati onal practiceofthe mass line ofthepart y, himselfseriously int heeducati on, practicalcontrol central "eight rules" andopposing"the fourwinds" and practici ng"three Suns",and checkthespi

7、ritofJiaoYul u,ide ology,solicit opi nions ba sed on outstanding problems checke dswing, carefula nalysi s andreflection. Will now checkreportis as foll ows:first,adherencetothe party'spoliticaldiscipline,eig htin thece ntralprovision,changethestyleofthebasicsituati on of1,in complia nce with th

8、eparty's political disciplines.Consci entiouslya bide bythe party's politica ldisci pline, abi de by t heConstit ution and t he rule s and regulati onsofthe part y,int hepolitical,i de ologi caland maintain highly consiste ntwith the CPCCe ntralCommittee onthe action,there i s noviolationoft

9、heparty'spolitical discipli nepr oblems. 2,in t heimpleme ntation of thecentralauthori tiesofthe eight provisi ons.Impr oving resear ch,im proving re searchmethods, butther e are less grass-r oots units, primaryfirst-ha nd a n ina dequategrasp ofthe pr oblem,w hich isto bestre ngthened int hefut

10、ure.Second,constr ucti on,stri ctly in a ccordance wit hthe provisi onstostreamlineand improvethequalityofmeetingsoftheConference.T hird,streamli ningfile bri efs,cult ureinv olvesallaspect sof propaganda andideolog y,sometimes duetothe pra ctical needsof inve ntion notificati ons, thisarea needs fu

11、rther一次性使用輸注器具產品注冊技術審查指導原則一、前言本指導原則旨在幫助和指導申請者/ 生產企業對一次性輸注器具產品注冊申報資料進行準備，以滿足技術審評的基本要求。同時有助于審評機構對該類產品進行科學規范的審評，提高審評工作的質量和效率。本指導原則是對一次性使用輸注器具產品注冊申報資料的一般要求，申請者 / 生產企業應依據具體產品的特性對注冊申報資料的內容進行充實和細化，并依據具體產品的特性確定其中的具體內容是否適用。本指導原則是對生產企業和審查人員的指導性文件, 但不包括注冊審批所涉及的行政事項，亦不作為法規強制執行, 如果有能夠滿足相關法規要求的其他方法，也可以采用，但是需要提供詳細

12、的研究資料和驗證資料。應在遵循相關法規的前提下使用本指導原則。本指導原則是在現行法規和標準體系以及當前認知水平下制定的，隨著法規和標準的不斷完善，以及科學技術的不斷發展，本指導原則相關內容也將進行適時的調整。二、適用范圍臨床治療與診斷時一次性使用，用于將容器內的液體通過插入靜脈的針頭或導管輸入患者血管的器械及用于將液體注入人體和抽取人體體液的器具及其組件統稱為一次性使用輸注器具。一次性使用輸注器具包括：一次性使用輸液器、一次性使用輸血器、一次性使用滴定管式輸液器、一次性使用靜脈輸液針、一次性使用精密過濾輸液器、一次性使用袋式輸液器、一次性使用輸液連接管路、一次性使用輸注泵、一次性使用無菌注射器

13、、一次性使用無菌注射針、一次性使用無菌胰島素注射器、一次性使用固定劑量疫苗注射器、一次性使用高壓造影注射器、一次性使用自毀式注射器等產品，也包括基本結構和預期用途與上述產品相似的產品及其組件，如一次性使用無菌注射器用活塞、一次性使用肝素帽、無針輸注裝置、三通閥、藥液過濾器等器具。.errd.ancegasd.v ",：,-"":"" oe *:.='，；1'.wf，".:.Sice te-.m - contog trre Sut.e-ie.d ie L-iy ol .-igs"."".ce

14、， dey .一 .to. .o2t o. "s.r. .terny, - hi 5 yeas a.r te .-e»- I oeer p-es I dig, i-o” i- tx, ia nc - sa nd -.st-l "Go.UI + Il_ ced" c.i ,- . ,-fm； f- B nke . dock ."-.pi- ”Olze teevr vi. id- o "ol icy lowaeve l.dd-e-a nd" lieaea . Al l .”. - efr cmet lime pes.le l .

15、on. i n .-d-dc - dl one, eg e .l.l p.vsi.,-“ te sye oftel-i .at” .i -”. .ce plt- d - i”.e.”etouSy a bile pii. l dsi pie - uto.d lie ue s -d - a.d ._igly-.siae .I wli te "CCe.I.l Vo- pay.poli-l e.t. -Iiori -o.s. .pr ov.gr -ea-, i. p.V.g e sea-.eio. b. te e .e._ grr oo. ga. w ii .Io be -.r-to., S

16、ti -y ia o.s三、基本要求（一）產品的技術資料產品的技術資料應當從技術層面論述中報產品的用途、設計、技術特征、與已上市產品 的比較、原材料控制、生產工藝、產品包裝驗證、產品滅菌驗證、產品有效期驗證、產品性 能要求及依據。至少應包含如下內容但不局限于此：1 .產品描述產品描述應全面、詳細，至少應包括申報產品名稱、預期用途、原材料、工作原理、結 構組成（相應圖示）、尺寸、技術指標、特殊性能、規格型號劃分的依據、以及是否符合相關 標準。2 .與已上市產品比較申請者應詳細說明同類產品國內外研究及臨床使用情況。描述本次申報器械與已上市器 械（包括本企業已上市同類產品或其他企業已上市同類產品）的

17、相似點和不同點，比較的項 目包括產品設計、預期用途、工作原理、結構組成、原材料、生產工藝、滅菌方式、性能指 標、有效期等，建議以列表方式列出。3 .產品命名產品名稱的命名應以發布的國家標準、行業標準以及醫療器械產品分類目錄中的產 品名稱和產品的技術性能為依據。產品名稱不得中英文混用。4 .原材料控制提交各組件全部組成材料（包括主材及其所有輔材）的化學名稱、化學結構式/分子式、分子量分布、商品名/材料代號、組成比例、供應商名稱、符合的標準等基本信息。說明原材料的選擇依據及其來源。原材料應具有穩定的供貨渠道以保證產品質量，需提 供原材料生產廠家的資質證明及外購協議。對外購組件也應當提交供方名錄、相

18、關資質證書 及外購協議。對原材料應當進行質量控制并符合相關材料標準要求。原材料的生物學性能應符合GB/T 16886. 1醫療器械生物學評價 第1部分：評價與試驗相關用途及使用部位的具體要求并the pri ncpileofsim plified EIA of construction pr oje cts in t he region. Intermsofland,linkedtothe im plementati on ofurba n andrural construction landincreaseand decrease ,repla cementi ndi catorsfor p

19、riorityarea s pr oject.Charges, int othe proje cts ofwater,ele ctricity,admi nistrative charges and preferentialpolici es. Inthe areaoftaxation,andsettledinarea s ofindustry anditspr oduction company,wit hin 5years after thecompletionoffiscalincentives t oenter prises.In termsoffinancing,integration

20、ofland, tax,fina ncial andot herresources,a nd construct"Government cre dit+businesscre dit"credit system,establi shment ofmarketization,commercializationa ndmodernization ofthe investmentandfi nancing platform;effective Bank-e nterprise docki ng, e ncourages private ca pitalintothe Park,t

21、oraiseindustrydevelopment fund.5,optimize theenvironment a ndservice industries. o create "pol icy lowlands, Highla nds, integrity ofservice land, developmentla nd"as thegoal,to optimizethe areaunder devel opme ntenv ironment.Al ladministrativelawenfor cementdepartme ntstoa ppoint afull-ti

22、mepersonne lstationed i n areasdedicatedt ocoor dinati ng andsolvi ng problems a ssociatedwit hbusinesse sinthi ssect or. Whe n thereare substantial issue s,se ctorleaders arrange d to per sonallyintervene,in-person,in-per son pushtang ible area buil ding agre en light,ea syline. Tofurt herreduce a

23、ndsta ndar dizeadmi nistrativeexaminationand appr ovalitems,simplifyexaminationa nd approvalli nks, impr oveefficiency;accor dingtot he.Since theeducati onal practiceofthe mass line ofthepart y, himselfseriously int heeducati on, practicalcontrol central " eight rules" andopposing"the

24、 fourwinds" and practici ng"three Suns",and checkthespirit ofJiaoYul u,ide olog y,solicit opi nions ba sed on outstanding problems checke dswing, carefula nalysi s andreflection.Will now checkreportis as foll ows:first,adherencetothe party'spoliticaldiscipline,eig htin thecentralp

25、rovision,changethestyleofthebasicsituati on of1,in compliancewith theparty'spoliticaldisciplines.Consci entiouslya bide bytheparty's politica ldisci pline, abi de by t heConstit ution and t he rule s and regulati onsofthe party,int hepolitical,i de ologi caland maintainhighly consiste ntwith

26、 the CPCCe ntralCommittee onthe action,thereisnoviolationoftheparty'spoliticaldiscipli nepr oblems. 2,in theimpleme ntation of thecentralauthori tiesofthe eightprovisi ons.Impr oving resear ch,im proving re searchmethods,butther e are less gr ass-r oots units, primaryfirst-ha nd a n ina dequateg

27、rasp ofthe pr oblem,which isto bestre ngthened inthefuture.Second,constructi on,stri ctly in a ccordance wit htheprovisi onstostreamlineand improvethequalityofmeetingsoftheConference.T hird,stream ningfile bri efs,cult ureinv olvesallaspect sof propaganda andideolog y,sometimesduetothe pra ctical ne

28、edsof inve ntion notificati ons, thisarea needs further提交生物學評價報告。對于生產企業自己研制生產的原材料粒料，生產企業應提供詳細的配方研制報告，其中包括符合GB 15593輸血（液）器具用軟聚氯乙烯塑料、 YY/T 0242醫用輸液、輸血、注射器具用聚丙烯專用料、 YY/T 0114醫用輸液、輸血、注射器具用聚乙烯專用料、 YY/T 0031輸液、輸血用硅橡膠管路及彈性件等相關標準要求的驗證報告。如果器具生產企業使用的是外購粒料，則應要求供方提交符合GB15593、YY/T 0242、YY/T0114 等相關標準的驗證報告。對不同批次進

29、料，供方都應提供符合GB15593 標準41 和42條， YY/T 0242標準 4 1、42、43條， YY/T 0114標準31、 32、33條 , YY/T 0031標準41、42、 4 3和 4 4條要求的出廠檢驗報告，器具生產企業則應對每批進料按上述條款進行進貨檢驗。應明確材料中的金屬成分，因為金屬成分可能會影響器械在核磁環境中的安全性。當材料中含有可能影響器械在核磁環境中的安全性的金屬成分時，申報企業應提供器械在核磁環境中的安全性的驗證資料。應明確每種原材料，包括添加劑、潤滑劑、粘結劑或其他添加物（如：色料添加劑、標記物、不透射線的物質）的成分、使用量、溶出物。以 DEH?曾塑的聚

30、氯乙烯（PVC作為原料的，需說明DEHP勺含量，提交產品中DEHF#放量范圍的研究報告以及人體可接受的劑量 范圍和依據。用于檢測DEHF#放量的測試液、試驗條件、檢測方法等應當采用經過科學驗證 的方法。如采用了可降低DEHFP!放的工藝，應當進行相關的驗證。對于預期用于輸注藥物的器具，企業需提交所輸注藥物與器具的相容性研究報告，至少應包括所申報的器具對所輸注藥物的吸附情況的實驗研究的數據與結論。同時，提交國內外關于所申報器具對藥物吸附情況的綜述報告。對于首次用于醫療器械方面的新材料，應提供該材料適合用于人體的預期使用部位的相關研究資料。5生產工藝詳細說明產品生產工藝過程及其確定的依據、質量控制

31、標準及其可靠性論證；確認關鍵工藝點并闡明其對產品物理性能、化學性能、機械性能、生物性能的影響；確認生產工藝的treamlining.Four are sta ndar dvisits,except asre quire d toparticipatei n traini ng, no ot her activit y. Fivei sto improve new sreporting,for propaga ndaw orkstri ctlyaccordi ngtothe regulati ons.Sixis strictly y ourpre sentati on publishe d st

32、ri ctlyaccordi ngtothe regulati ons.Seven isstrictlyt hrift, require dthe use ofvehicle s and office spaceand corporatehospitality.3, change the style.Propagandaand ide ol ogicalw ork ofthe newsit uation andne wrequirements ofthe ne w tasks, had done alot offruitfulwork, has madema nyachievements,bu

33、t further cl osertothegrass roots,closetoreality,closet othe massesa nd al so i nade quatei nnovation m ust continuetoim prove.Se cond,t he "fourwi nds" some outstanding issues1,oppose formalism.Onetheoryis thathe didn't,withle ss closecontact. The oretical study ofconsciousne ssis not

34、 highe nough,sy stem performa ncei s not strong e nough;m ore passivelear ning, activelear ningfewge neralitiesa ndlear nmore, delvi ng intole ss.E specially ba sed on rati onalt hinki ng on major issues,applying theorytoguidetheworkdonei s notg ood enoug h,not really understandandgraspthespiritandt

35、he pri ncpileofsim plified EIA of construction pr oje cts in t he region. Intermsofland,linkedtothe im plementati on ofurba n andrural construction landincreaseand decrease ,repla cementi ndciatorsfor priorityarea s pr oject.Charges, int otheproje cts ofwater,ele ctricity,admi nistrative charges and

36、 preferentialpolici es. Intheareaoftaxation, and settle d inarea s ofindustry anditspr oduction compa ny,wit hin 5years after thecompletionoffiscalincentives t oenter prises.In termsoffinancing,integrationofland, tax,fina ncial andot her resource s,a nd construct"Government credit+ businesscred

37、it"credit system,establi shment ofmarketization,commercializationa ndmodernization ofthe investmenta ndfi nancingplatform;effective Bank-e nterprise docking, e ncouragesprivate ca pitalintothe Park,toraiseindustrydevelopmentfund.5,optimizetheenvironment a ndservice industries. o create "po

38、l icy lowlands, Highla nds, integrity ofserviceland, dev elopmentland"as thegoal,to optimizetheareaunderdevel opme ntenvironment.Al ladministrativelawenfor cementdepartme ntstoa ppoint afull-timepersonnelstationed i n areasdedicatedt ocoor dinati ng andsolvi ng problems a ssociatedwit hbusiness

39、e sinthi ssect or. Whe n thereare substantial issue s,se ctorleaders arrange d to per sonallyintervene,in-person,in-per son pushtang ible area buil ding agre en light,ea syline. Tofurt herreduce a ndsta ndar dizeadmi nistrativeexaminationand approvalitems,simplifyexaminationa nd a pproval li nks, im

40、proveefficiency;accor dingtot he.Since theeducati onal practiceofthe mass line ofthepart y, himselfseriously int heeducati on, practicalcontrol central " eight rules" andopposing"the fourwinds" and practici ng"three Sun s",and checkthe spirit ofJiaoYul u,ide ology,solic

41、itopi nions ba sed on outstanding problems checke dsw ing, carefula nalysi s andreflection.Will now checkreportis as follows:first,adherencetothe party'spoliticaldiscipline,eig htin thecentralprovision,changethestyleofthebasicsituati on of1,in compliancewith theparty's political disciplines.

42、Conscientiouslya bide bytheparty's politica ldisci pline, abi de by t heConstit ution and t he rule s and regulati onsofthe party,int hepolitical,i de ologi caland maintainhighly consiste ntwith the CPCCe ntralCommittee onthe action,there i s noviolationoftheparty'spoliticaldiscipli nepr obl

43、ems. 2,in theimpleme ntation ofthecentralauthori tiesofthe eightprovisi ons.Impr oving r esear ch,im proving re searchmethods,butther eare less grass-r ootsunits, primaryfirst-handa n ina dequategraspofthe pr oblem,which isto bestre ngthened int hefuture.Second,constructi on,stri ctlyin a ccordance

44、wit hthe provisi onstostreamlineand improvethequalityofmeetingsoftheConference.T hird,streamli ningfile bri efs,cult ureinv olvesallaspect sof propaganda andideolog y,sometimesduetothe pra ctical needsof inve ntion notificati ons, thisarea needs further穩定性。對生產加工過程中所使用的所有輔劑、助劑、粘合劑等添加劑均應說明使用劑量、對殘留量的控制

45、措施和接受標準以及安全性驗證報告。6產品包裝產品包裝驗證可依據有關國內、國際標準進行（如GB/T19633、ISO11607、ASTM D-4169等） ，提交產品的包裝驗證報告。包裝材料的選擇應至少考慮以下因素：包裝材料的物理化學性能；包裝材料的毒理學特性；包裝材料與產品的適應性；包裝材料與成型和密封過程的適應性；包裝材料與滅菌過程的適應性；包裝材料所能提供的物理、化學和微生物屏障保護；包裝材料與使用者使用時的要求（如無菌開啟）的適應性；包裝材料與標簽系統的適應性；包裝材料與貯存運輸過程的適合性。7產品滅菌提交產品滅菌方法的選擇依據及驗證報告。器械的滅菌應通過 GB 1827& GB

46、18279或 GB18280確認并進行常規控制，無菌保證水平應保證（SAD達到1X10”。滅菌過程的選擇 應考慮以下因素：產品與滅菌過程間的適應性；包裝材料與滅菌過程的適應性。8產品穩定性要求（有效期驗證）包括產品有效期和產品包裝有效期。產品穩定性驗證可采用加速老化或實時老化的研究，實時老化的研究是唯一能夠反映產品在規定儲存條件下實際穩定性要求的方法。加速老化研究試驗的具體要求可參考ASTM F1980在進行加速老化試驗研究時應注意：產品在選擇的環境條件的老化機制應與在實時正常使用環境老化條件下真實發生產品老化的機制一致。對首次注冊未提交實時老化研究資料的，企業在重新注冊的資料中應提交實時老化

47、研究資料以確定產品的實際穩定性。9一般性能要求主要包括物理性能、化學性能、生物性能等方面的要求及其制定依據。應包括但不限于以下內容：（ 1）物理性能注射器類產品主要包括產品外觀、結構、各組件的顏色、尺寸（內徑、外徑、長度、容treamlining.Four are sta ndar dvisits,except asre quire d toparticipatei n traini ng, no ot her activit y. Fivei sto improve new sreporting,for propaga ndaw orkstri ctlyaccordi ngtothe reg

48、ulati ons.Sixis strictly y ourpre sentati on publishe d stri ctlyaccordi ngtothe regulati ons.Seven isstrictlyt hrift, require dthe use ofvehicle s and office spaceand corporatehospitality.3, change the style.Propagandaand ide ol ogicalw ork ofthe newsit uation andne wrequirements ofthe ne w tasks,

49、had done alot offruitfulwork, has madema nyachievements,but further cl osertothegrass roots,closetoreality,closetothemassesand al so i nade quatei nnovation m ust continuetoim prove.Se cond,t he "fourwi nds" some outstanding issues 1, oppose formalism.Onetheoryis thathe didn't,withle s

50、s closecontact. The oretical study ofconsciousne ssis not highe nough,sy stem performa ncei s not strong e nough;m ore pa ssivelear ning, activelear ningfewge neralitiesa ndlear nmore, delvi ng intole ss.E specially ba sed on rati onalt hinki ng on major issues,applying theorytoguidethework done i s

51、 notg ood enoug h,not really understandandgrasp thespirita ndessence ofthe scientific Outlook on devel opment ,di d nottruly achieve mastery,toapply, to a certai n extent, affectthe devel opme ntand implementation of ideas and initiatives.Second,workarrangements,andlesssupervision.Propagandaa nd ide

52、ol ogica lworki sthe objective,w hichneedsto keepthecontinuityeffortsde ployed,but stresse din t hew orktime,lesssupervision.Forexample,colorwe ekends int hesummer theatricalactivities,city squareperforma nce s,urgi ngtow nships, communities a nd ruralareas showsthe impleme ntation i s ina de quate,

53、 i nsufficientculturala n e ducational roletoplay.Thirdbaseenough,mastergrass -less real.Pr opaga ndaa nd ide ologi calwork inthe ne wsituati on ofchara cteristicsand regularityofenough, deepe noughforgra ss-roots public opniion Dy namics survey,for grass -roots typi callydrive l ess. Forexample,r u

54、ralcultureteam a ctive,.I'm notactively takethe initiative t o takeup,the lack ofspirit ofdaringt o,resulting in somejobhadalotofpower,butnotangibleresults.Third,innovation,lackofmotivation.Ema ncipati on did not end,innovationdoesnotexist.In practicalw ork, notyour hea d,previous work experienc

55、e, lackofinnovationinitiatives,studyonthe characteristi cs ofpr opagandaa nd ideol ogicalw ork underthe new situation through,grip ongrassroots ideologicaltrendsa nd cha ngesare notdee p,to promote newinitiativesa nd ex plore newmethods of ideol ogicala nd culturalwork isnot much,and some lackofrele

56、vancea nd timeliness.4,discipline,l owering, andhardw orkare la cking. Whil eworki ngand enterpri singspirit down.No realsol utiontotreatyourselfright, correctlytreatpasthonors,theircomplacency,and work to see the irscoresmore, le sscheck ing hi sown shortcoming s, like to liste ntothe praise, satis

57、fiedface, onli nepr omotion,there ar etypical ,and l ackof hig hstandardsand strict requirements,t heeffect is real.Se cond hard drivele ss. On hardandthe pri ncpileofsim plified EIA of construction proje cts in t he region. Intermsofland,linked tothe im plementati on ofurba n andruralconstruction l

58、andincreaseand decrease,repla cementindi catorsfor priorityarea s pr oject.Charges, int othe proje cts ofwater,ele ctricity,admi nistrative chargesand preferentialpolici es. Intheareaoftaxation,andsettled inarea s ofindustry anditspr oduction company,wit hin 5years after thecompletionoffiscali ncentives t oenter prises.In termsoffinancing, integrationof land, tax,financi al andot her resource s,a nd construct"Governme nt credit+businesscre dit"credit system, establi shment ofmarketization,