DosaTec婧跺獟浠笓涓鸿嵂鐗?/span>婧跺嚭搴︽娴嬩腑婧跺獟鐨勮嚜鍔ㄥ寲閰嶅埗鑰岃璁★紝鏈骇鍝佸叿鏈夎嚜鍔ㄨ繘娑层€佹贩鍚堛€佽嚜鍔ㄥ姞鐑€佽嚜鍔ㄨ劚姘斻€佽嚜鍔ㄦ竻娲楀拰鑷姩鎵撳嵃鎶ュ憡绛夊姛鑳斤紝鍙互婊¤冻鑽墿鐮斿彂鍜岃川閲忔帶鍒朵汉鍛樼殑婧跺獟閰嶅埗浣跨敤闇€姹傘€侟/span>

鏈华鍣ㄩ厤鍒剁殑婧跺獟绗﹀悎浠ヤ笅娉曡涓婧跺獟鐨勯渶姹傦細

ü涓浗鑽吀2015鐗0931婧跺嚭搴︿笌閲婃斁搴︽祴瀹氭硶

üUSP <711> 锛孅724> 锛孶SP <1087>

üCFR 21 Part 11

涓昏鎶€鏈弬鏁?/span>
鍝佺墝	DosaTec
鍨嬪彿	DosaPrep X8
浜у湴	寰峰浗
鍗曟**閰嶇疆浣撶Н	8L
鍒嗛厤鍘熺悊	閲嶉噺娉旤/span>
鍒嗛厤閲廃/span>	150~8000mL
鍒嗛厤鍑嗙‘搴?/span>	<1%
鍙垎閰嶆憾鍑烘澂鏁伴噺	1~36锛堜緷鎹崟涓憾濯掍綋绉級
娓╁害鍔犵儹鑼冨洿	瀹ゆ俯鍒?span>45鈩傸/span>
娓╁害鍑嗙‘鎬?/span>	±2鈩傸/span>
杩涙恫鍙ｈ繃婊｜/span>	20μm
閰告恫涓庢憾鍓傛瘮渚婞/span>	1:3~1:100
閰嶅埗鏁堢巼	32L/h锛堝彇鍐充簬鏂规硶鍙傛暟鐨勮缃級
鏂规硶鏁伴噺	22涓?/span>
鑴辨皵鐪熺┖搴?/span>	锛淈span>200mbar锛屽疄闄匋/span><100mbar
涓€閿嚜鍔ㄦ竻娲楀姛鑳键/span>	鍏锋湁
鎶ュ憡鎵撳嵃鍜岃拷韪?/span>	鍏锋湁锛屾爣閰嶆墦鍗版満
IQOQ鏈嶅姟	鍏锋湁锛屾爣閰岦/span>

浜у搧涓昏鐗圭偣

1.绠€鍖栫殑鎿嶄綔鍗曞厓

浠櫒閰嶅LCD灞忓拰6涓寜閿紝浣滀负鎿嶄綔鍗曞厓锛岀畝鍗曟槗鐢ㄣ€侟/span>

浠櫒杩愯鐨勫悇闃舵閮芥湁鐩稿簲鐨勬寚绀虹伅鎸囩ず銆侟/span>

鏂规硶鍙傛暟涓粎鏈夊洓涓弬鏁伴渶瑕佽缃細婧跺獟鍒嗛厤浣撶Н锛岄吀娑秉/span>/娣诲姞鍓備綋绉紝闇€瑕佽濉殑婧跺嚭鏉暟閲忥紝婧跺獟娓╁害銆侟/span>

2.鍘荤瀛愭按缁忚繃20μm杩囨护

鍘荤瀛愭按杩涘叆浠櫒鍐呰厰鍓嶏紝缁忚繃20μm瀛斿緞鐨勬护鑶滆繃婊ゃ€侟/span>

浠櫒鑷姩璁＄畻杩囨护鍣ㄤ娇鐢ㄥ鍛斤紝榛樿涓裹/span>5000L銆侟/span>

3.鏇存柊鐨勫揩閫熸帴澶滁/span>

鍘荤瀛愭按銆侀吀娑茬殑杩涘彛閲囩敤蹇€熸帴澶达紝鏂逛究瀹夎鍜岀淮鎶ゃ€侟/span>

婧跺獟鍑哄彛閲囩敤蹇€熸帴澶达紝鏂逛究瀹夎鍜岀淮鎶ゃ€侟/span>

4.澶氱鎶ュ憡杈撳嚭

婧跺獟鍒跺鎶ュ憡杈撳嚭锛岄獙璇佹姤鍛婅緭鍑恒€侟/span>

鎶ュ憡鍐呭鍖呮嫭锛氬疄楠屼华鍣ㄤ俊鎭€佽繃婊ゅ櫒浣跨敤瀵垮懡銆佹柟娉曘€佸垎閰嶉噺浣撶Н鍙婂亸宸€佹俯搴︺€佸疄楠屾棩鏈熴€佸疄楠屽憳绛夈€侟/span>