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(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則一、前言本指導(dǎo)原則旨在幫助和指導(dǎo)申請(qǐng)者/ 生產(chǎn)企業(yè)對(duì)一次性輸注器具產(chǎn)品注冊(cè)申報(bào)資料進(jìn)行準(zhǔn)備，以滿足技術(shù)審評(píng)的基本要求。同時(shí)有助于審評(píng)機(jī)構(gòu)對(duì)該類產(chǎn)品進(jìn)行科學(xué)規(guī)范的審評(píng)，提高審評(píng)工作的質(zhì)量和效率。本指導(dǎo)原則是對(duì)一次性使用輸注器具產(chǎn)品注冊(cè)申報(bào)資料的一般要求，申請(qǐng)者 / 生產(chǎn)企業(yè)應(yīng)依據(jù)具體產(chǎn)品的特性對(duì)注冊(cè)申報(bào)資料的內(nèi)容進(jìn)行充實(shí)和細(xì)化，并依據(jù)具體產(chǎn)品的特性確定其中的具體內(nèi)容是否適用。本指導(dǎo)原則是對(duì)生產(chǎn)企業(yè)和審查人員的指導(dǎo)性文件, 但不包括注冊(cè)審批所涉及的行政事項(xiàng)，亦不作為法規(guī)強(qiáng)制執(zhí)行, 如果有能夠滿足相關(guān)法規(guī)要求的其他方法，也可以采用，但是需要提供詳細(xì)

12、的研究資料和驗(yàn)證資料。應(yīng)在遵循相關(guān)法規(guī)的前提下使用本指導(dǎo)原則。本指導(dǎo)原則是在現(xiàn)行法規(guī)和標(biāo)準(zhǔn)體系以及當(dāng)前認(rèn)知水平下制定的，隨著法規(guī)和標(biāo)準(zhǔn)的不斷完善，以及科學(xué)技術(shù)的不斷發(fā)展，本指導(dǎo)原則相關(guān)內(nèi)容也將進(jìn)行適時(shí)的調(diào)整。二、適用范圍臨床治療與診斷時(shí)一次性使用，用于將容器內(nèi)的液體通過插入靜脈的針頭或?qū)Ч茌斎牖颊哐艿钠餍导坝糜趯⒁后w注入人體和抽取人體體液的器具及其組件統(tǒng)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(chǎn)品，也包括基本結(jié)構(gòu)和預(yù)期用途與上述產(chǎn)品相似的產(chǎn)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- ”O(jiān)lze 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(chǎn)品的技術(shù)資料產(chǎn)品的技術(shù)資料應(yīng)當(dāng)從技術(shù)層面論述中報(bào)產(chǎn)品的用途、設(shè)計(jì)、技術(shù)特征、與已上市產(chǎn)品 的比較、原材料控制、生產(chǎn)工藝、產(chǎn)品包裝驗(yàn)證、產(chǎn)品滅菌驗(yàn)證、產(chǎn)品有效期驗(yàn)證、產(chǎn)品性 能要求及依據(jù)。至少應(yīng)包含如下內(nèi)容但不局限于此：1 .產(chǎn)品描述產(chǎn)品描述應(yīng)全面、詳細(xì)，至少應(yīng)包括申報(bào)產(chǎn)品名稱、預(yù)期用途、原材料、工作原理、結(jié) 構(gòu)組成（相應(yīng)圖示）、尺寸、技術(shù)指標(biāo)、特殊性能、規(guī)格型號(hào)劃分的依據(jù)、以及是否符合相關(guān) 標(biāo)準(zhǔn)。2 .與已上市產(chǎn)品比較申請(qǐng)者應(yīng)詳細(xì)說明同類產(chǎn)品國內(nèi)外研究及臨床使用情況。描述本次申報(bào)器械與已上市器 械（包括本企業(yè)已上市同類產(chǎn)品或其他企業(yè)已上市同類產(chǎn)品）的

17、相似點(diǎn)和不同點(diǎn)，比較的項(xiàng) 目包括產(chǎn)品設(shè)計(jì)、預(yù)期用途、工作原理、結(jié)構(gòu)組成、原材料、生產(chǎn)工藝、滅菌方式、性能指 標(biāo)、有效期等，建議以列表方式列出。3 .產(chǎn)品命名產(chǎn)品名稱的命名應(yīng)以發(fā)布的國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)以及醫(yī)療器械產(chǎn)品分類目錄中的產(chǎn) 品名稱和產(chǎn)品的技術(shù)性能為依據(jù)。產(chǎn)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(xué)名稱、化學(xué)結(jié)構(gòu)式/分子式、分子量分布、商品名/材料代號(hào)、組成比例、供應(yīng)商名稱、符合的標(biāo)準(zhǔn)等基本信息。說明原材料的選擇依據(jù)及其來源。原材料應(yīng)具有穩(wěn)定的供貨渠道以保證產(chǎn)品質(zhì)量，需提 供原材料生產(chǎn)廠家的資質(zhì)證明及外購協(xié)議。對(duì)外購組件也應(yīng)當(dāng)提交供方名錄、相

18、關(guān)資質(zhì)證書 及外購協(xié)議。對(duì)原材料應(yīng)當(dāng)進(jìn)行質(zhì)量控制并符合相關(guān)材料標(biāo)準(zhǔn)要求。原材料的生物學(xué)性能應(yīng)符合GB/T 16886. 1醫(yī)療器械生物學(xué)評(píng)價(jià) 第1部分：評(píng)價(jià)與試驗(yàn)相關(guān)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(xué)評(píng)價(jià)報(bào)告。對(duì)于生產(chǎn)企業(yè)自己研制生產(chǎn)的原材料粒料，生產(chǎn)企業(yè)應(yīng)提供詳細(xì)的配方研制報(bào)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(yī)用輸液、輸血、注射器具用聚丙烯專用料、 YY/T 0114醫(yī)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(guān)標(biāo)準(zhǔn)要求的驗(yàn)證報(bào)告。如果器具生產(chǎn)企業(yè)使用的是外購粒料，則應(yīng)要求供方提交符合GB15593、YY/T 0242、YY/T0114 等相關(guān)標(biāo)準(zhǔn)的驗(yàn)證報(bào)告。對(duì)不同批次進(jìn)

29、料，供方都應(yīng)提供符合GB15593 標(biāo)準(zhǔn)41 和42條， YY/T 0242標(biāo)準(zhǔn) 4 1、42、43條， YY/T 0114標(biāo)準(zhǔn)31、 32、33條 , YY/T 0031標(biāo)準(zhǔn)41、42、 4 3和 4 4條要求的出廠檢驗(yàn)報(bào)告，器具生產(chǎn)企業(yè)則應(yīng)對(duì)每批進(jìn)料按上述條款進(jìn)行進(jìn)貨檢驗(yàn)。應(yīng)明確材料中的金屬成分，因?yàn)榻饘俪煞挚赡軙?huì)影響器械在核磁環(huán)境中的安全性。當(dāng)材料中含有可能影響器械在核磁環(huán)境中的安全性的金屬成分時(shí)，申報(bào)企業(yè)應(yīng)提供器械在核磁環(huán)境中的安全性的驗(yàn)證資料。應(yīng)明確每種原材料，包括添加劑、潤滑劑、粘結(jié)劑或其他添加物（如：色料添加劑、標(biāo)記物、不透射線的物質(zhì)）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(chǎn)品中DEHF#放量范圍的研究報(bào)告以及人體可接受的劑量 范圍和依據(jù)。用于檢測(cè)DEHF#放量的測(cè)試液、試驗(yàn)條件、檢測(cè)方法等應(yīng)當(dāng)采用經(jīng)過科學(xué)驗(yàn)證 的方法。如采用了可降低DEHFP!放的工藝，應(yīng)當(dāng)進(jìn)行相關(guān)的驗(yàn)證。對(duì)于預(yù)期用于輸注藥物的器具，企業(yè)需提交所輸注藥物與器具的相容性研究報(bào)告，至少應(yīng)包括所申報(bào)的器具對(duì)所輸注藥物的吸附情況的實(shí)驗(yàn)研究的數(shù)據(jù)與結(jié)論。同時(shí)，提交國內(nèi)外關(guān)于所申報(bào)器具對(duì)藥物吸附情況的綜述報(bào)告。對(duì)于首次用于醫(yī)療器械方面的新材料，應(yīng)提供該材料適合用于人體的預(yù)期使用部位的相關(guān)研究資料。5生產(chǎn)工藝詳細(xì)說明產(chǎn)品生產(chǎn)工藝過程及其確定的依據(jù)、質(zhì)量控制

31、標(biāo)準(zhǔn)及其可靠性論證；確認(rèn)關(guān)鍵工藝點(diǎn)并闡明其對(duì)產(chǎn)品物理性能、化學(xué)性能、機(jī)械性能、生物性能的影響；確認(rèn)生產(chǎn)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(wěn)定性。對(duì)生產(chǎn)加工過程中所使用的所有輔劑、助劑、粘合劑等添加劑均應(yīng)說明使用劑量、對(duì)殘留量的控制

45、措施和接受標(biāo)準(zhǔn)以及安全性驗(yàn)證報(bào)告。6產(chǎn)品包裝產(chǎn)品包裝驗(yàn)證可依據(jù)有關(guān)國內(nèi)、國際標(biāo)準(zhǔn)進(jìn)行（如GB/T19633、ISO11607、ASTM D-4169等） ，提交產(chǎn)品的包裝驗(yàn)證報(bào)告。包裝材料的選擇應(yīng)至少考慮以下因素：包裝材料的物理化學(xué)性能；包裝材料的毒理學(xué)特性；包裝材料與產(chǎn)品的適應(yīng)性；包裝材料與成型和密封過程的適應(yīng)性；包裝材料與滅菌過程的適應(yīng)性；包裝材料所能提供的物理、化學(xué)和微生物屏障保護(hù)；包裝材料與使用者使用時(shí)的要求（如無菌開啟）的適應(yīng)性；包裝材料與標(biāo)簽系統(tǒng)的適應(yīng)性；包裝材料與貯存運(yùn)輸過程的適合性。7產(chǎn)品滅菌提交產(chǎn)品滅菌方法的選擇依據(jù)及驗(yàn)證報(bào)告。器械的滅菌應(yīng)通過 GB 1827& GB

46、18279或 GB18280確認(rèn)并進(jìn)行常規(guī)控制，無菌保證水平應(yīng)保證（SAD達(dá)到1X10”。滅菌過程的選擇 應(yīng)考慮以下因素：產(chǎn)品與滅菌過程間的適應(yīng)性；包裝材料與滅菌過程的適應(yīng)性。8產(chǎn)品穩(wěn)定性要求（有效期驗(yàn)證）包括產(chǎn)品有效期和產(chǎn)品包裝有效期。產(chǎn)品穩(wěn)定性驗(yàn)證可采用加速老化或?qū)崟r(shí)老化的研究，實(shí)時(shí)老化的研究是唯一能夠反映產(chǎn)品在規(guī)定儲(chǔ)存條件下實(shí)際穩(wěn)定性要求的方法。加速老化研究試驗(yàn)的具體要求可參考ASTM F1980在進(jìn)行加速老化試驗(yàn)研究時(shí)應(yīng)注意：產(chǎn)品在選擇的環(huán)境條件的老化機(jī)制應(yīng)與在實(shí)時(shí)正常使用環(huán)境老化條件下真實(shí)發(fā)生產(chǎn)品老化的機(jī)制一致。對(duì)首次注冊(cè)未提交實(shí)時(shí)老化研究資料的，企業(yè)在重新注冊(cè)的資料中應(yīng)提交實(shí)時(shí)老化

47、研究資料以確定產(chǎn)品的實(shí)際穩(wěn)定性。9一般性能要求主要包括物理性能、化學(xué)性能、生物性能等方面的要求及其制定依據(jù)。應(yīng)包括但不限于以下內(nèi)容：（ 1）物理性能注射器類產(chǎn)品主要包括產(chǎn)品外觀、結(jié)構(gòu)、各組件的顏色、尺寸（內(nèi)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,