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椋熷搧瀹夊叏鍥藉鏍囧噯GB 5009.2-2024銆婇鍝佺浉瀵瑰瘑搴︾殑娴嬪畾銆嬩箣 涓婃捣浣宠埅D70 U鍨嬫尟鑽＄鏁板瓧瀵嗗害璁¤В璇寸瘒
鍙戝竷鏃堕棿锛
2024-09-24 14:37
涓婃捣浣宠埅 D70 U 鍨嬫尟鑽＄鏁板瓧瀵嗗害璁″湪椋熷搧瀹夊叏鍥藉鏍囧噯 GB 5009.2-2024銆婇鍝佺浉瀵瑰瘑搴︾殑娴嬪畾銆婞/font>涓浉鍏冲簲鐢ㄨВ璇村涓婞/font>锛欬/font>
1. 鍘熺悊濂戝悎搴︼細
• GB 5009.2-2024 涓鍥涙硶 U 鍨嬫尟鑽＄鏁板瓧瀵嗗害璁℃硶鐨勫師鐞嗘槸鏍规嵁鐢电寮曞彂鐜荤拑 U 鍨嬬浜х敓鎸崱锛岃鎸崱棰戠巼浜屾鏂圭殑澶у皬涓庢祴閲忔睜涓瘯鏍风殑瀵嗗害鍛堢嚎鎬у叧绯伙紝浠庤€屾祴瀹氳瘯鏍风殑瀵嗗害锛屽啀鍒╃敤 20°C 涓嬫祴寰楁恫浣撹瘯鏍风殑瀵嗗害浠ュ強姘寸殑瀵嗗害鍙幏寰楄瘯鏍峰湪 20°C 鐨勭浉瀵瑰瘑搴︺€備笂娴蜂匠鑸?/font>D70鍏ㄨ嚜鍔ㄥ瘑搴﹁涔熸槸閲囩敤U鍨嬬鎸崱娉曞師鐞嗭紝瀹岀編缁撳悎Peltier绮剧‘鎺ф俯鎶€鏈拰楂樻竻瑙嗛鎽勫儚鎶€鏈紝涓嶄絾涓虹敤鎴锋彁渚涘噯纭€佺ǔ瀹氥€佸彲闈犵殑娴嬭瘯缁撴灉锛岃繕涓虹敤鎴峰甫鏉ラ珮鏁堜究鎹风殑娴嬭瘯鎰熷彈銆傞珮娓呰棰戝彲鏂逛究鐪嬪埌鏍峰搧涓槸鍚︽湁姘旀场褰卞搷锛岄噰鐢ㄨ剦鍐叉縺鍙戯紝楂樼簿搴︽娴嬫妧鏈紝鏂逛究鐢ㄦ埛鍑嗙‘蹇€熸祴寰楁牱鍝佸瘑搴﹀強瀵嗗害鐩稿叧鍙傛暟銆侟/font>
2. 浠櫒鍙傛暟绗﹀悎搴︼細
• 娴嬮噺鑼冨洿锛氳瀵嗗害璁＄殑娴嬮噺鑼冨洿涓 0g/cm³ 鑷 3g/cm³锛岀鍚堟爣鍑嗕腑瀵归鍝佺浉瀵瑰瘑搴︽祴閲忚寖鍥寸殑瑕佹眰锛岃兘澶熸弧瓒冲ぇ澶氭暟椋熷搧娑蹭綋鏍峰搧鐨勬祴閲忋€侟/font>
• 鍒嗚鲸鐜囷細鍏跺垎杈ㄧ巼杈惧埌 0.00001g/cm³锛岃緝楂樼殑鍒嗚鲸鐜囧彲浠ユ洿绮剧‘鍦版祴閲忛鍝佹牱鍝佺殑瀵嗗害鍙樺寲锛屼繚璇佹祴閲忕粨鏋滅殑鍑嗙‘鎬э紝绗﹀悎鏍囧噯瀵规祴閲忕簿搴︾殑杈冮珮瑕佹眰銆侟/font>
• 閲嶅鎬э細閲嶅鎬т负±0.00005g/cm³锛岃緝楂樼殑閲嶅鎬ф剰鍛崇潃澶氭娴嬮噺鍚屼竴椋熷搧鏍峰搧鏃讹紝缁撴灉鐨勭ǔ瀹氭€ц緝楂橈紝杩欏浜庝繚璇佸疄楠岀粨鏋滅殑鍙潬鎬ч潪甯搁噸瑕侊紝涔熸弧瓒虫爣鍑嗕腑瀵规祴閲忛噸澶嶆€х殑瑕佹眰銆侟/font>
• 鍑嗙‘搴︼細鍑嗙‘搴︿负±0.00008g/cm³锛岃緝楂樼殑鍑嗙‘搴﹁兘澶熺‘淇濇祴閲忕粨鏋滀笌鐪熷疄鍊肩殑鎺ヨ繎绋嬪害锛岀鍚堟爣鍑嗗娴嬮噺缁撴灉鍑嗙‘鎬х殑瑕佹眰銆侟/font>
• 鎺ф俯鍔熻兘锛氫笂娴蜂匠鑸 D70 鍐呯疆甯曞皵璐存帶娓╋紝鎺ф俯鑼冨洿涓 5鈩冿紞65鈩冿紝鎺ф俯绋冲畾搴︿负±0.02鈩冦€侟/font>GB 5009.2-2024 鏍囧噯铏芥湭鏄庣‘瑙勫畾 U 鍨嬫尟鑽＄鏁板瓧瀵嗗害璁＄殑鍏蜂綋鎺ф俯鍙傛暟锛屼絾娓╁害瀵规恫浣撳瘑搴︽湁鏄捐憲褰卞搷锛岃瀵嗗害璁＄殑鎺ф俯鍔熻兘鍙互淇濊瘉鍦ㄤ笉鍚屾俯搴︽潯浠朵笅锛屽椋熷搧鏍峰搧杩涜鍑嗙‘鐨勬俯搴︽帶鍒讹紝浣挎祴閲忕粨鏋滄洿绗﹀悎鏍囧噯瑕佹眰銆侟/font>
3. 鎿嶄綔鍙婂姛鑳界壒鎬т紭鍔军/font>鍒涙柊鐐更/font>锛欬/font>
• 鑷姩鍖栭泦鎴愶細瀹炵幇涓€閿祴瀹氬姛鑳斤紝鍐呯疆甯曞皵璐存帶娓╋紝鎻愰珮绮惧害鍜岀ǔ瀹氭€?/font>銆侟/font>鎿嶄綔绠€渚匡紝鑳藉鎻愰珮瀹為獙鏁堢巼锛屽噺灏戜汉涓烘搷浣滆宸紝绗﹀悎鏍囧噯涓蹇€熴€佸噯纭祴閲忕殑瑕佹眰銆侟/font>
• 瑙傛祴鏂瑰紡锛氶噰鐢ㄩ珮娓呰棰戣娴嬫柟寮忥紝鍙互鏂逛究鍦扮湅鍒版牱鍝佷腑鏄惁鏈夋皵娉″奖鍝嶏紝閬垮厤鍥犳皵娉″鑷寸殑娴嬮噺璇樊锛屼繚璇佹祴閲忕粨鏋滅殑鍑嗙‘鎬с€侟/font>
• 鏁版嵁绠＄悊锛欬/font>鍙€氳繃鎵撳嵃鏈虹洿鎺ユ墦鍗版暟鎹紝鍏锋湁鏁版嵁瀛樺偍銆佺敤鎴风鐞嗐€佸璁¤拷韪€佺數瀛愮鍚嶃€佽嚜瀹氫箟鏂规硶搴撶瓑鍔熻兘锛屾柟渚垮疄楠屾暟鎹殑绠＄悊鍜岃拷婧紝绗﹀悎鏍囧噯瀵瑰疄楠屾暟鎹鐞嗙殑瑕佹眰銆侟/font>
• 绗﹀悎21CFR Part 11銆佸璁¤拷韪€佽嵂鍏伏/font>鍙婄數瀛愮鍚嶃€侟/font>
鎬讳綋鑰岃█锛屼笂娴蜂匠鑸?/font> D70 U鍨嬫尟鑽＄鏁板瓧瀵嗗害璁″湪鍘熺悊銆佷华鍣ㄥ弬鏁般€佹搷浣滃強鍔熻兘鐗规€х瓑鏂归潰閮借兘澶熻緝濂藉湴婊¤冻椋熷搧瀹夊叏鍥藉鏍囧噯 GB 5009.2-2024銆婇鍝佺浉瀵瑰瘑搴︾殑娴嬪畾銆嬬殑瑕佹眰锛屽彲浠ョ敤浜庨鍝佺浉瀵瑰瘑搴︾殑鍑嗙‘娴嬪畾銆備絾鍦ㄥ疄闄呬娇鐢ㄨ繃绋嬩腑锛屼粛闇€鎸夌収鏍囧噯瑕佹眰杩涜浠櫒鐨勬牎姝ｃ€佹牱鍝佺殑鍒跺鍜屾祴閲忕瓑鎿嶄綔锛屼互纭繚娴嬮噺缁撴灉鐨勫噯纭€у拰鍙潬鎬с€侟/font>
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