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娌冲寳浜氫笢鍒惰嵂鏈夐檺鍏徃閲囪喘浣宠埅婊寸偣杞寲鐐规祴瀹氫华
鍙戝竷鏃堕棿锛
2021-07-26 00:00
璐拱鍘傚锛欬/span>娌冲寳浜氫笢鍒惰嵂鏈夐檺鍏徃 鏃堕棿锛欬/span>2021骞?鏈?nbsp;
浜у搧鍚嶇О锛欬/span>婊寸偣杞寲鐐规祴瀹氫华 瑙勬牸鍨嬪彿锛欬/span>JHD70
娌冲寳浜氫笢鍒惰嵂鏈夐檺鍏徃鍓嶈韩涓哄紶瀹跺彛涓滈鍒惰嵂鍘傦紝濮嬪缓浜嶞/span>1993骞达紝鍘傚潃浣嶄簬寮犲鍙ｅ競妗ヤ笢鍖洪櫟鍥寳璺?鍙枫€傛渤鍖椾簹涓滃埗鑽湁闄愬叕鍙哥洰鍓嶆垚鐔熺殑浜у搧鏄姏蹇呰揪®锛堝悺缃楁様搴疯蒋鑶忥級锛屾垜鍏徃鏄浗鍐呴瀹惰幏寰楀悺缃楁様搴疯蒋鑶忔壒鍑嗘枃鍙风殑鍘傚锛屽苟鎸佹湁鍥涚被鏂拌嵂鐨勬柊鑽瘉涔︺€侟/span>
鍏ㄨ嚜鍔?/span>婊寸偣杞寲鐐规祴瀹氫华涓昏鐢ㄤ簬娴嬪畾闈炴櫠浣撻珮鍒嗗瓙鍖栧悎鐗╃殑婊寸偣鍜岃蒋鍖栫偣锛岀‘瀹氬叾娴撳瘑搴︺€佽仛鍚堝害銆佽€愮儹搴︾瓑鐞嗗寲鐗规€э紝濡傜叅鐒︽补锛屾播闈掞紝鏉鹃锛屽嚒澹灄锛屾鼎婊戞补銆佸悎鎴愭爲鑴傚強鍚勭鑽啅鐨勬垚浠芥娴嬫垨璐ㄩ噺鎺у埗锛屽彲浠ｆ浛浼犵粺鐨勪箤姘忔淮鐐规祴瀹氬拰鐜悆娉曡蒋鍖栫偣娴嬪畾銆備匠鑸?/span>婊寸偣杞寲鐐规祴瀹氫华閰嶅楂樼簿搴︽帶娓╂妧鏈拰楂樻竻瑙嗛鎽勫儚鎶€鏈紝鍙柟渚挎竻鏅扮殑鐪嬪埌鏍峰搧鐘舵€佸彉鍖栫殑鍏ㄨ繃绋嬶紝鑷姩妫€娴嬪疄鏃跺浘璋辨樉绀猴紝娓╁害绋嬪簭鎺у埗锛屾暟鏄捐鏁帮紝绮惧害楂橈紝鎬ц兘绋冲畾锛岀鍚圏/span>21CFR Part 11銆佸璁¤拷韪€佽嵂鍏稿強鐢靛瓙绛惧悕锛涚鍚圓STM(D3204銆丏3461銆丏3104銆?nbsp;D3954銆丏6090)锛孌IN(51801銆?nbsp;51920)锛孏B鈭昑 2294-2019锛孖SO 锛?176-1972銆?625-2锛夊強銆婅嵂鍏搞€嬬瓑鐩稿叧鏍囧噯锛屾槸鑽紒鐮斿彂鍒惰嵂鍜岀敓浜ф妸鎺х殑蹇呰璁惧銆侟/span>
鎰熻阿娌冲寳浜氫笢鍒惰嵂鏈夐檺鍏徃瀵逛匠鑸华鍣ㄧ殑璁ゅ彲锛屽笇鏈涙垜浠殑浠櫒鑳戒负璐靛叕鍙哥殑妫€楠屾娴嬪伐浣滃甫鏉ラ珮鏁堝拰浼樿川鐨勪娇鐢ㄦ劅鍙楋紝鎴戜滑灏嗕互浼樿川鐨勪骇鍝佸拰鍞悗涓烘偍鏈嶅姟锛屾湡寰呭啀娆″悎浣滐紝骞舵杩庤吹鍙哥浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆侟/span>
鍏抽敭璇嶏細鎶樺厜浠
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