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class="text-muted">發(fā)布時(shí)間：2025-02-06 07:11:18 來(lái)源：<a href="http://plasticsurgerycash.com/" target="_blank">萍鄉(xiāng)市三聯(lián)環(huán)?；すこ逃邢薰?/a> 閱覽次數(shù)：99967次 </p> <div id="8gzv3zcq3zww" class="content"><p>①公司試劑產(chǎn)品質(zhì)檢實(shí)驗(yàn)室設(shè)產(chǎn)品檢測(cè)室、化學(xué)檢測(cè)室、物理檢測(cè)室、留樣間、儀器室、準(zhǔn)備間、培養(yǎng)間、微生物限度室、陽(yáng)性對(duì)照室。微生物限度檢驗(yàn)為局部百級(jí)的超凈工作臺(tái)，陽(yáng)性對(duì)照室配備生物安全柜。質(zhì)檢室配備有與試劑產(chǎn)品、環(huán)境水質(zhì)等檢測(cè)相適宜的檢測(cè)儀器，能滿足目前試劑產(chǎn)品質(zhì)量檢測(cè)需要。公司儀器產(chǎn)品檢測(cè)設(shè)設(shè)備檢測(cè)室，配備了與儀器檢測(cè)相適宜的儀器檢測(cè)設(shè)備，能夠滿足目前儀器產(chǎn)品質(zhì)量檢測(cè)的需要。②質(zhì)量部人員，在后續(xù)工作中，需要加強(qiáng)崗位專業(yè)培訓(xùn)，培訓(xùn)合格后，開展QA/QC方面的工作，包括公司物料、產(chǎn)品、生產(chǎn)等過(guò)程的質(zhì)量活動(dòng)。公司質(zhì)量部，屬總經(jīng)理直接領(lǐng)導(dǎo)，由總經(jīng)理授權(quán)負(fù)責(zé)公司日常質(zhì)量管理工作。質(zhì)量部經(jīng)理直接對(duì)公司總經(jīng)理負(fù)責(zé)。③QA主要負(fù)責(zé)生產(chǎn)全過(guò)程、物料供應(yīng)、倉(cāng)儲(chǔ)的質(zhì)量監(jiān)控、批生產(chǎn)記錄、批檢驗(yàn)記錄等的審核和物料供應(yīng)商的審計(jì)等。產(chǎn)品批生產(chǎn)記錄由生產(chǎn)部根據(jù)生產(chǎn)的品種、規(guī)格、數(shù)量使用，操作人員根據(jù)操作的實(shí)際填寫后由生產(chǎn)部部門經(jīng)理和QA對(duì)批生產(chǎn)記錄進(jìn)行審核，審查有無(wú)不符合工藝要求的操作內(nèi)容，審核合格后報(bào)質(zhì)量經(jīng)理。經(jīng)QA審核合格的批生產(chǎn)記錄、批檢驗(yàn)記錄送質(zhì)量部經(jīng)理審批后簽發(fā)放合格報(bào)告或合格證。對(duì)主要物料。備皮刀的材質(zhì)通常采用高質(zhì)量的不銹鋼制成，具有優(yōu)良的耐腐蝕性和耐用性。貴州備皮刀生產(chǎn)廠家</p><p style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州備皮刀生產(chǎn)廠家,備皮刀" src="https://img01.71360.com/w3/nj4p7n/20230912/c497cdefb67bdf887a8be4e94631b0c5.png"></p><p>公司制訂了物料儲(chǔ)存狀態(tài)管理及儲(chǔ)存期限規(guī)定。進(jìn)出庫(kù)物料、產(chǎn)品，分別掛黃色待驗(yàn)牌和綠色的合格牌。不合格物料、產(chǎn)品，專區(qū)存11放、有效隔離，并掛有明顯的紅色不合格狀態(tài)標(biāo)志牌。貨物堆碼分批分區(qū)，批與批有便于貨物運(yùn)輸?shù)拈g隔，貨物發(fā)放執(zhí)行先進(jìn)先出的原則。所有物料在臨近儲(chǔ)存期限時(shí)，進(jìn)行復(fù)驗(yàn)，合格者再規(guī)定其儲(chǔ)存時(shí)間，不合格者按不合格的處理程序處理。印有文字的標(biāo)簽、說(shuō)明書、彩盒等包裝材料，設(shè)置專區(qū)、專柜，由專人管理，并根據(jù)要求制定了管理規(guī)程，明確了從設(shè)計(jì)、校核、印刷、儲(chǔ)存、保管、發(fā)放、使用、銷毀的管理規(guī)程。標(biāo)簽、說(shuō)明書、彩盒的入庫(kù)、發(fā)放、采用計(jì)數(shù)的方法，保證數(shù)據(jù)之間相符。公司設(shè)有成品倉(cāng)庫(kù)；原輔料間設(shè)有專區(qū)，標(biāo)簽和說(shuō)明書等包裝材料，存放于專柜，由專人負(fù)責(zé)管理。各區(qū)容量滿足生產(chǎn)需要。倉(cāng)庫(kù)通風(fēng)良好，溫濕度符合規(guī)范要求，有防鼠、防蟲設(shè)施。遼寧一次性使用備皮刀廠家直銷備皮刀在手術(shù)前被多方面使用，為醫(yī)生的手術(shù)操作提供必要的幫助。</p><p style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州備皮刀生產(chǎn)廠家,備皮刀" src="https://img01.71360.com/w3/nj4p7n/20230912/913f56d44f8d6aebdba3c8fe3e5f4a51.png?wmk=842568242034774016"></p><p style="text-indent:25px">因本公司的備皮刀以無(wú)菌形式提供，所以備皮刀在醫(yī)療器械管理類別上為Ⅱ類醫(yī)療器械。臨床上，為患者進(jìn)行手術(shù)前，必須對(duì)患者的表皮進(jìn)行清潔處理，而患者表皮的毛發(fā)是首先要清潔的對(duì)象，因?yàn)槊l(fā)上面有很對(duì)微生物，如果不進(jìn)行，對(duì)患者手術(shù)部位的表皮的清潔和消毒肯定是無(wú)效的或者是不徹底的，對(duì)患者進(jìn)行手術(shù)必然帶來(lái)較高的風(fēng)險(xiǎn)，因此，備皮刀正是基于臨床用于手術(shù)前備皮而研發(fā)的產(chǎn)品。備皮刀作為一類醫(yī)療器械，在本公司已經(jīng)合法上市多年，因國(guó)家法律法規(guī)的調(diào)整，按食品藥品監(jiān)督管局的相關(guān)法律法規(guī)的規(guī)定，備皮刀已經(jīng)升為二類產(chǎn)品，因此按照《醫(yī)療器械注冊(cè)管理辦法》的規(guī)定，本次備皮刀按擬上市注冊(cè)申報(bào)。備皮刀由刀架、刀片和頂蓋組成；按刀片的不同，分為單刃和雙刃兩種。備皮刀刀架采用符合GB/T12671-2008規(guī)定的聚苯乙烯樹脂制成；備皮刀刀片采用符合GB/T3527規(guī)定的刮臉刀片冷軋鋼帶材料制成。</p><p style="text-indent:25px">2.1備皮刀的基本尺寸應(yīng)符合表1的規(guī)定2.2備皮刀刀架應(yīng)塑化均勻、光滑、無(wú)鋒棱、毛刺和裂紋。2.3備皮刀刀片表面應(yīng)色澤均勻，刃口應(yīng)無(wú)銹斑、缺口，精磨層連續(xù)不斷。2.4鋒利度備皮刀刀片刃口應(yīng)鋒利，當(dāng)切割3-0真絲捻制不涂層縫合線(線徑為0.21mm-0.22mm)時(shí)，其切割力應(yīng)不大于0.80N。2.5刀片固定應(yīng)穩(wěn)固，無(wú)明顯歪斜。2.6無(wú)菌滅菌提供的備皮刀應(yīng)無(wú)菌。2.7環(huán)氧乙烷殘留量滅菌提供的備皮刀經(jīng)環(huán)氧乙烷滅菌后，其環(huán)氧乙烷殘留量應(yīng)不大于10ug/g。揚(yáng)州永安備皮刀供臨床手術(shù)前備皮用。</p><p style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州備皮刀生產(chǎn)廠家,備皮刀" src="https://img01.71360.com/w3/nj4p7n/20230912/f9b218d12d0d464c4215d08822f5442e.png"></p><p>（2）廠房設(shè)施及設(shè)備管理控制①車間環(huán)境定期：車間內(nèi)布局合理，生產(chǎn)線的人、物流順暢，互不妨礙。根據(jù)實(shí)際生產(chǎn)工序不同，劃分和確定非凈化區(qū)和10萬(wàn)級(jí)別5的生產(chǎn)區(qū)。非凈化區(qū)與凈化區(qū)的壓差為大于10Pa。進(jìn)入潔凈區(qū)的空氣，按潔凈級(jí)別要求凈化，溫度、濕度、壓差控制在規(guī)定的范圍內(nèi)。生產(chǎn)工藝流程合理，具有滿足產(chǎn)品生產(chǎn)工藝要求的功能間，操作空間適當(dāng)。②為保證整體凈化效果和生產(chǎn)中不同工序的要求，凈化系統(tǒng)共設(shè)置了送風(fēng)系統(tǒng)、回風(fēng)系統(tǒng)。凈化系統(tǒng)采用初效、中效、高效三級(jí)過(guò)濾，整個(gè)系統(tǒng)采用頂送凈化風(fēng)和回風(fēng)柱側(cè)下回風(fēng)至機(jī)房的循環(huán)凈化系統(tǒng)。③試劑生產(chǎn)潔凈區(qū)內(nèi)設(shè)配液間、劃膜間、噴金間、內(nèi)包間、膠體金處理間、干燥間、容器具清洗間、潔具間、洗衣房等功能間。其中配液間、洗衣房、容器具清洗間、膠體金處理間均分布有純化水用水點(diǎn)，清洗池均為不銹鋼材質(zhì)。備皮刀的設(shè)計(jì)獨(dú)特，通常采用不銹鋼材質(zhì)制成，具有鋒利的刀刃和舒適的手柄，方便醫(yī)生操作。江蘇醫(yī)用備皮刀源頭廠家</p><p style="text-indent:25px">刮胡刀則多采用塑料或金屬材質(zhì)，刀刃相對(duì)較鈍，需要反復(fù)刮剃才能達(dá)到清潔的效果。貴州備皮刀生產(chǎn)廠家</p><p>這樣就能夠根據(jù)備皮需要來(lái)調(diào)節(jié)刀片的刀口伸出上壓蓋的距離，從而適應(yīng)于不同的使用要求，另外在調(diào)節(jié)刀片的同時(shí)，刀片滑動(dòng)會(huì)帶動(dòng)連接柱移動(dòng)，從而使得柔性板伸出滑槽，對(duì)刀片進(jìn)行壓緊，便于醫(yī)護(hù)人員的備皮處理。進(jìn)一步，所述柔性板的長(zhǎng)度不小于刀片的長(zhǎng)度。有益效果：這樣柔性板能將刀片滑出的部分進(jìn)行遮擋。進(jìn)一步，所述安裝座均為空心結(jié)構(gòu)，所述驅(qū)動(dòng)機(jī)構(gòu)位于安裝座內(nèi)。有益效果：這樣設(shè)置是為了從外觀上來(lái)看，整個(gè)備皮刀的結(jié)構(gòu)是比較簡(jiǎn)單的，沒(méi)有復(fù)雜的零件位于備皮刀的外部，從而影響備皮。進(jìn)一步，所述驅(qū)動(dòng)機(jī)構(gòu)包括轉(zhuǎn)桿和擺動(dòng)柱，所述轉(zhuǎn)桿轉(zhuǎn)動(dòng)連接在安裝座上，所述轉(zhuǎn)桿平行于刀片的刀口邊，所述擺動(dòng)柱一端固定在轉(zhuǎn)桿上，一端固定在刀片的底部。有益效果：通過(guò)轉(zhuǎn)動(dòng)轉(zhuǎn)桿，轉(zhuǎn)桿隨轉(zhuǎn)桿同步轉(zhuǎn)動(dòng)，由于刀片有一定的變形能力，刀片的刀口處可能出現(xiàn)向上微翹的情形，而此時(shí)柔性板滑出，不*遮擋滑出的刀片，同時(shí)也起到按壓刀片的作用。進(jìn)一步，所述轉(zhuǎn)桿一端貫穿安裝座，且轉(zhuǎn)桿伸出安裝座一端固定有旋鈕。有益效果：旋鈕的設(shè)置有利于醫(yī)護(hù)人員轉(zhuǎn)動(dòng)轉(zhuǎn)桿，從而調(diào)節(jié)刀片。進(jìn)一步，所述上壓蓋的橫截面呈向上凸起的弧形。有益效果：將上壓蓋設(shè)置為弧形使得，上壓蓋只有兩側(cè)壓緊在刀片上。貴州備皮刀生產(chǎn)廠家</p></div> 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