一次性使用口腔護理包，包括方盤、彎盤、金屬鑷子、紙巾、生理鹽水、備用棉球、壓舌板、圍兜、干棉球，其特征在于上述藥品及用具均密封于一塑料薄膜包內。推薦一次性使用無菌陰道擴張器該塑料薄膜包置于另一密封外包裝塑料薄膜包內，護理包內配備有嚴格消毒過的方盤１個、彎盤１個、金屬鑷子２把、紙巾１張、生理鹽水１袋、備用棉球１袋、壓舌板１根、圍兜１塊、干棉球１９個，可滿足臨床上一次口腔護理操作所需。一次性使用無菌陰道擴張器批發適合在災害(hai)、野外救護(hu)(hu)、戰爭條件下(xia)使(shi)用(yong)(yong)，當(dang)遇有患者需進行口腔護(hu)(hu)理時，即可打開(kai)護(hu)(hu)理包，針對護(hu)(hu)理所需采用(yong)(yong)不同用(yong)(yong)品(pin)用(yong)(yong)具進行口腔護(hu)(hu)理操(cao)作。

如(ru)何預(yu)防插(cha)導(dao)(dao)(dao)尿(niao)包(bao)時(shi)出現感(gan)(gan)染現象?全科(ke)(ke)醫(yi)(yi)生(sheng)是經過全科(ke)(ke)醫(yi)(yi)學專業培(pei)訓，臨(lin)床技能(neng)(neng)全面、醫(yi)(yi)德高尚的(de)(de)高素質基層醫(yi)(yi)療(liao)保健人(ren)才,富有(you)獨(du)立(li)工(gong)作(zuo)能(neng)(neng)力(li),對個人(ren)家(jia)庭及社區(qu)提供便捷、廉(lian)價的(de)(de)防、 治保康(kang)全方位的(de)(de)優(you)質服(fu)務(wu)。開展全科(ke)(ke)醫(yi)(yi)療(liao)服(fu)務(wu), 如(ru)果沒有(you)具有(you)活力(li)的(de)(de)全科(ke)(ke)醫(yi)(yi)生(sheng)做堅實的(de)(de)基礎(chu),工(gong)作(zuo)將缺乏生(sheng)氣和動力(li),那(nei)種以單純(chun)的(de)(de)專科(ke)(ke)醫(yi)(yi)療(liao)的(de)(de)服(fu)務(wu)體系,勢必(bi)造成(cheng)(cheng)醫(yi)(yi)療(liao)秩序的(de)(de)混亂,也(ye)沒有(you)任何國家(jia)的(de)(de)經濟能(neng)(neng)夠負(fu)擔得(de)起。那(nei)么,插(cha)導(dao)(dao)(dao)尿(niao)管(guan)(guan)如(ru)何預(yu)防感(gan)(gan)染呢?導(dao)(dao)(dao)尿(niao)包(bao)相(xiang)(xiang)關尿(niao)路(lu)感(gan)(gan)染預(yu)防SOP尿(niao)路(lu)感(gan)(gan)染(UTI)是二位常(chang)見醫(yi)(yi)院感(gan)(gan)染類型, 75% ~ 80%與(yu)留置(zhi)導(dao)(dao)(dao)尿(niao)管(guan)(guan)相(xiang)(xiang)關。為有(you)效預(yu)防導(dao)(dao)(dao)尿(niao)管(guan)(guan)相(xiang)(xiang)關尿(niao)路(lu)感(gan)(gan)染,特制(zhi)定以下控制(zhi)措(cuo)施:插(cha)管(guan)(guan)前準備與(yu)插(cha)管(guan)(guan)時(shi)的(de)(de)措(cuo)施1.盡量避免不(bu)必(bi)要的(de)(de)留置(zhi)導(dao)(dao)(dao)尿(niao);2.仔(zi)細檢查無菌導(dao)(dao)(dao)尿(niao)包(bao)，如(ru)過期、外包(bao)裝破損(sun)潮(chao)濕(shi),不(bu)得(de)使用;3.根據年齡、性別、尿(niao)道情(qing)況選(xuan)擇合適的(de)(de)導(dao)(dao)(dao)尿(niao)管(guan)(guan)口徑、類型。通(tong)常(chang)成(cheng)(cheng)年男性選(xuan)16F ,女(nv)性選(xuan)14F ;4.規范(fan)手(shou)(shou)衛(wei)生(sheng)和載手(shou)(shou)套的(de)(de)程序;5.常(chang)規的(de)(de)消毒方法:用0.1%的(de)(de)新潔(jie)爾滅消毒尿(niao)道口及其(qi)周圍皮(pi)(pi)膚粘(zhan)膜,程序如(ru)下:男性:自尿(niao)道口、龜頭向(xiang)外旋轉擦拭消毒,注意洗凈包(bao)皮(pi)(pi)及冠狀(zhuang)溝。女(nv)性:先清(qing)洗外陰,其(qi)原則由上至下,由內向(xiang)外,然(ran)后(hou)清(qing)洗尿(niao)道口、前庭、兩側大小陰唇(chun),后(hou)會(hui)陰、肛門,每一個棉球不(bu)能(neng)(neng)重復(fu)使用;6.插(cha)管(guan)(guan)過程嚴格(ge)執(zhi)行無菌操作(zuo),動作(zuo)要輕柔(rou),避免尿(niao)道粘(zhan)膜損(sun)傷;7.對留置(zhi)導(dao)(dao)(dao)尿(niao)患者,應采用密閉式(shi)引流(liu)系統。

一次性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)無(wu)菌導(dao)尿包注意事項(xiang)。注意事項(xiang)。產(chan)(chan)品(pin)(pin)按手術(shu)室無(wu)菌操作規定使(shi)(shi)(shi)(shi)用(yong)(yong)。2.包裝破損切(qie)勿使(shi)(shi)(shi)(shi)用(yong)(yong)。一次性(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)導(dao)尿包3.本品(pin)(pin)為一次性(xing)(xing)產(chan)(chan)品(pin)(pin)，切(qie)勿再次使(shi)(shi)(shi)(shi)用(yong)(yong)。4.產(chan)(chan)品(pin)(pin)使(shi)(shi)(shi)(shi)用(yong)(yong)后應按照醫院或環保(bao)部(bu)門(men)要求進行處理。【禁忌癥】對橡膠、聚丙烯(xi)塑料(liao)、無(wu)紡(fang)布(bu)、脫脂(zhi)棉過敏者(zhe)慎用(yong)(yong)。【使(shi)(shi)(shi)(shi)用(yong)(yong)說明(ming)】打開(kai)產(chan)(chan)品(pin)(pin)小(xiao)包裝后即(ji)可使(shi)(shi)(shi)(shi)用(yong)(yong)；根(gen)據(ju)使(shi)(shi)(shi)(shi)用(yong)(yong)需求，依次將產(chan)(chan)品(pin)(pin)中(zhong)的(de)組件鋪墊好，以獲得良好的(de)使(shi)(shi)(shi)(shi)用(yong)(yong)效(xiao)果(guo)。【儲存條件、方法(fa)】貯存在(zai)陰(yin)涼(liang)、干燥、通風、無(wu)腐(fu)蝕性(xing)(xing)氣體的(de)環境(jing)中(zhong)，遠(yuan)離火源(yuan)及易(yi)燃物(wu)。

2019年(nian)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)是(shi)(shi)報(bao)告(gao)(gao)大(da)(da)廳(ting)在對(dui)(dui)(dui)(dui)要(yao)從(cong)事一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)或者(zhe)要(yao)進(jin)入(ru)投(tou)(tou)(tou)資(zi)之(zhi)前，對(dui)(dui)(dui)(dui)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)的(de)(de)(de)(de)相(xiang)關因素(su)以(yi)及(ji)(ji)(ji)具體的(de)(de)(de)(de)行(xing)(xing)(xing)情進(jin)行(xing)(xing)(xing)具體研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)、分(fen)(fen)析(xi)(xi)、調查以(yi)及(ji)(ji)(ji)評估(gu)項(xiang)目的(de)(de)(de)(de)可(ke)行(xing)(xing)(xing)性(xing)(xing)(xing)(xing)(xing)、效(xiao)果(guo)效(xiao)益等，從(cong)而(er)提出(chu)建(jian)設性(xing)(xing)(xing)(xing)(xing)意見以(yi)及(ji)(ji)(ji)建(jian)議對(dui)(dui)(dui)(dui)策。為(wei)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)投(tou)(tou)(tou)資(zi)決策者(zhe)或者(zhe)是(shi)(shi)主管(guan)總(zong)結下研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)性(xing)(xing)(xing)(xing)(xing)報(bao)告(gao)(gao)！ 一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)主要(yao)是(shi)(shi)對(dui)(dui)(dui)(dui)分(fen)(fen)析(xi)(xi)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)需求、供(gong)給、經營(ying)(ying)特(te)性(xing)(xing)(xing)(xing)(xing)、獲取(qu)能力(li)、產(chan)業(ye)鏈和價(jia)(jia)值鏈等多(duo)方(fang)(fang)面的(de)(de)(de)(de)內(nei)容(rong)，整(zheng)合(he)行(xing)(xing)(xing)業(ye)、市(shi)場、企業(ye)、用(yong)(yong)(yong)(yong)戶(hu)等多(duo)層面數(shu)據(ju)(ju)和信息資(zi)源，為(wei)客戶(hu)提供(gong)深度的(de)(de)(de)(de)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)市(shi)場研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)，以(yi)專業(ye)的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)(fang)法幫(bang)助客戶(hu)深入(ru)的(de)(de)(de)(de)了(le)解一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)情況，發(fa)現投(tou)(tou)(tou)資(zi)價(jia)(jia)值和投(tou)(tou)(tou)資(zi)機(ji)會，規避(bi)經營(ying)(ying)風險，提高管(guan)理(li)(li)(li)(li)(li)和運(yun)營(ying)(ying)能力(li)。一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)必須對(dui)(dui)(dui)(dui)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)行(xing)(xing)(xing)業(ye)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)內(nei)容(rong)和方(fang)(fang)法進(jin)行(xing)(xing)(xing)全面的(de)(de)(de)(de)闡述和論(lun)(lun)證，對(dui)(dui)(dui)(dui)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)過(guo)(guo)(guo)程(cheng)(cheng)(cheng)中所獲取(qu)的(de)(de)(de)(de)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)資(zi)料(liao)進(jin)行(xing)(xing)(xing)全面系統的(de)(de)(de)(de)整(zheng)理(li)(li)(li)(li)(li)和分(fen)(fen)析(xi)(xi)，通(tong)過(guo)(guo)(guo)圖表、統計結果(guo)及(ji)(ji)(ji)文(wen)獻資(zi)料(liao)，或以(yi)縱向的(de)(de)(de)(de)發(fa)展過(guo)(guo)(guo)程(cheng)(cheng)(cheng)，或橫向類別分(fen)(fen)析(xi)(xi)提出(chu)論(lun)(lun)點、分(fen)(fen)析(xi)(xi)論(lun)(lun)據(ju)(ju)，進(jin)行(xing)(xing)(xing)論(lun)(lun)證。一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)分(fen)(fen)：一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)對(dui)(dui)(dui)(dui)象和方(fang)(fang)法 、研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)內(nei)容(rong)和假設 、研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)步(bu)驟及(ji)(ji)(ji)過(guo)(guo)(guo)程(cheng)(cheng)(cheng)以(yi)及(ji)(ji)(ji)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)結果(guo)的(de)(de)(de)(de)分(fen)(fen)析(xi)(xi)與討論(lun)(lun)。一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)內(nei)容(rong)的(de)(de)(de)(de)邏輯性(xing)(xing)(xing)(xing)(xing)是(shi)(shi)整(zheng)個研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)思路邏輯性(xing)(xing)(xing)(xing)(xing)的(de)(de)(de)(de)寫照，沒有一個好(hao)的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)基(ji)礎(chu)以(yi)及(ji)(ji)(ji)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)渠(qu)道方(fang)(fang)法，是(shi)(shi)寫不(bu)出(chu)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)科(ke)(ke)研(yan)(yan)(yan)(yan)(yan)報(bao)告(gao)(gao)。對(dui)(dui)(dui)(dui)于(yu)一次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)護(hu)(hu)(hu)理(li)(li)(li)(li)(li)包(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)內(nei)容(rong)報(bao)告(gao)(gao)大(da)(da)廳(ting)相(xiang)對(dui)(dui)(dui)(dui)如實(shi)地反映客觀情況，一切敘述、說(shuo)明、推斷、引(yin)用(yong)(yong)(yong)(yong)，恰如其分(fen)(fen)。文(wen)字、用(yong)(yong)(yong)(yong)詞(ci)應力(li)求準確。概念表述用(yong)(yong)(yong)(yong)科(ke)(ke)學(xue)性(xing)(xing)(xing)(xing)(xing)用(yong)(yong)(yong)(yong)語，避(bi)免用(yong)(yong)(yong)(yong)常識(shi)性(xing)(xing)(xing)(xing)(xing)用(yong)(yong)(yong)(yong)語，以(yi)免讀(du)者(zhe)費解或產(chan)生歧義。當然，研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)告(gao)(gao)的(de)(de)(de)(de)文(wen)字我(wo)們也努力(li)做到(dao)簡單、明了(le)、通(tong)順、流暢，既(ji)要(yao)明白如話，又要(yao)把研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)效(xiao)果(guo)準確地、科(ke)(ke)學(xue)地表達(da)出(chu)來。通(tong)過(guo)(guo)(guo)全面的(de)(de)(de)(de)調查研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)以(yi)及(ji)(ji)(ji)分(fen)(fen)析(xi)(xi)論(lun)(lun)證某個建(jian)設或改造工程(cheng)(cheng)(cheng)。某種科(ke)(ke)學(xue)研(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)、某項(xiang)商務活動(dong)切實(shi)可(ke)行(xing)(xing)(xing)而(er)提出(chu)的(de)(de)(de)(de)一種書面材料(liao)。

醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)是醫(yi)療(liao)(liao)(liao)器械(xie)(xie)研制(zhi)、生(sheng)產(chan)、經營、使用(yong)以及(ji)監督(du)管(guan)(guan)(guan)理所共(gong)同(tong)遵循的技(ji)術(shu)規范(fan)，是醫(yi)療(liao)(liao)(liao)器械(xie)(xie)監管(guan)(guan)(guan)和(he)(he)產(chan)業(ye)(ye)發(fa)(fa)展(zhan)(zhan)(zhan)的重(zhong)要技(ji)術(shu)支(zhi)撐(cheng)。藥(yao)監局(ju)高度(du)重(zhong)視(shi)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)工(gong)作(zuo)，按照“四(si)個嚴”的要求，結合醫(yi)療(liao)(liao)(liao)器械(xie)(xie)產(chan)業(ye)(ye)發(fa)(fa)展(zhan)(zhan)(zhan)和(he)(he)監管(guan)(guan)(guan)工(gong)作(zuo)實(shi)際，不斷(duan)完善(shan)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)管(guan)(guan)(guan)理制(zhi)度(du)體系(xi)、持續(xu)開(kai)展(zhan)(zhan)(zhan)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)制(zhi)修訂(ding)工(gong)作(zuo)，我國(guo)(guo)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)體系(xi)不斷(duan)完善(shan)，醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)對監管(guan)(guan)(guan)和(he)(he)產(chan)業(ye)(ye)發(fa)(fa)展(zhan)(zhan)(zhan)的技(ji)術(shu)支(zhi)撐(cheng)能力(li)持續(xu)提升(sheng)。一、加(jia)強(qiang)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)制(zhi)度(du)建設。為(wei)貫徹(che)落實(shi)國(guo)(guo)務院深化(hua)標(biao)(biao)(biao)(biao)準(zhun)(zhun)化(hua)改(gai)革重(zhong)大決策(ce)部(bu)署，依(yi)據《中華人民共(gong)和(he)(he)國(guo)(guo)標(biao)(biao)(biao)(biao)準(zhun)(zhun)化(hua)法》，立足我國(guo)(guo)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)產(chan)業(ye)(ye)發(fa)(fa)展(zhan)(zhan)(zhan)和(he)(he)監管(guan)(guan)(guan)工(gong)作(zuo)實(shi)際，2017年(nian)4月，原食品(pin)(pin)(pin)藥(yao)品(pin)(pin)(pin)監管(guan)(guan)(guan)總(zong)局(ju)修訂(ding)印發(fa)(fa)《醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)管(guan)(guan)(guan)理辦法》，該辦法的出臺對指導我國(guo)(guo)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)管(guan)(guan)(guan)理、規范(fan)標(biao)(biao)(biao)(biao)準(zhun)(zhun)制(zhi)修訂(ding)、促(cu)進標(biao)(biao)(biao)(biao)準(zhun)(zhun)實(shi)施、提升(sheng)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)質(zhi)量(liang)等起到了(le)(le)積極作(zuo)用(yong)。為(wei)貫徹(che)落實(shi)《醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)管(guan)(guan)(guan)理辦法》，原食品(pin)(pin)(pin)藥(yao)品(pin)(pin)(pin)監管(guan)(guan)(guan)總(zong)局(ju)先(xian)后印發(fa)(fa)《醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)制(zhi)修訂(ding)工(gong)作(zuo)管(guan)(guan)(guan)理規范(fan)》和(he)(he)《醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)報批(pi)發(fa)(fa)布(bu)工(gong)作(zuo)細則(ze)》等文件，進一步規范(fan)了(le)(le)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)工(gong)作(zuo)程序，強(qiang)化(hua)了(le)(le)標(biao)(biao)(biao)(biao)準(zhun)(zhun)精(jing)細化(hua)過程管(guan)(guan)(guan)理，為(wei)提升(sheng)醫(yi)療(liao)(liao)(liao)器械(xie)(xie)標(biao)(biao)(biao)(biao)準(zhun)(zhun)質(zhi)量(liang)奠定(ding)了(le)(le)堅實(shi)的制(zhi)度(du)基(ji)礎。