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鐢ㄦ埗闇�姹傛(bi膩o)婧�(zh菙n)
锛�URS锛�
绯荤当(t菕ng)鍚嶇ū :鐢熷寲鍩归(y菐ng)绠�
瑷�(sh猫)鍌欑法铏�(h脿o): NA |
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璧疯崏/瀵╂牳/ 鎵规簴(zh菙n) |
绨藉悕 |
鏃ユ湡 |
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璧疯崏鑰� |
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骞� 鏈� 鏃� |
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璩�(zh矛)閲忕鐞嗛儴瀵╂牳 |
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骞� 鏈� 鏃� |
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宸ョ▼閮�瀵╂牳 |
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骞� 鏈� 鏃� |
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GMP 绗﹀悎鎬у鏍� |
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骞� 鏈� 鏃� |
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QA 瀵╂牳 |
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骞� 鏈� 鏃� |
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璩�(zh矛)閲忕鐞嗛儴闁�(m茅n)鎵规簴(zh菙n) |
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骞� 鏈� 鏃� |
鐩寗
1.0 鑳屾櫙浠嬬垂
2.0 鐩殑鍜岃寖鍦�
3.0 鍙冭�冭硣鏂�
4.0 绺(xi臎)
5.0 鐢ㄦ埗闇�姹�
1.0 鑳屾櫙浠嬬垂
鐝�(xi脿n)鏈夌殑1鑷�(t谩i)鐢熷寲鍩归(y菐ng)绠遍渶瑕佺敤浜庢ā鎿亴瑁濇ǎ鍝佸煿椁�(y菐ng)锛屾墍浠ョ従(xi脿n)鏈夌殑鐢熷寲鍩归(y菐ng)绠变笉鑳芥豢瓒虫棩甯哥殑瀵�(sh铆)椹�(y脿n)闇�瑕�锛岄渶璩�(g貌u)璨蜂竴鑷�(t谩i)瀹归噺鍦�600L鑷�800L鐨勭敓鍖栧煿椁�(y菐ng)绠�銆�
2.0 鐩殑鍜岃寖鍦�
鐐轰簡婊胯冻寰敓鐗╁(sh铆)椹�(y脿n)瀹ゆ棩甯告椹�(y脿n)鐨勮姹傦紝鎵�浠ラ渶璩�(g貌u)涓�鍊�(g猫)鍩归(y菐ng)绠辨豢瓒充笂杩拌姹�銆傛摤閲囪臣(g貌u)鐨勭敓鍖栧煿椁�(y菐ng)绠卞皣鎳�(y墨ng)鐢ㄤ簬鍩归(y菐ng)瀹や腑灏�(du矛)姘寸郴绲�(t菕ng)銆佹垚鍝佹垨涓枔鐢�(ch菐n)鍝佺殑寰敓鐗╅檺搴�锛屼互鍙婂皪(du矛)鐒�(w煤)鑿屾娓�(c猫)妯ｅ搧鐨勫井鐢熺墿鍩归(y菐ng)銆�
3.0 鍙冭�冭硣鏂�
鍦ㄤ笅琛ㄤ腑鍒楀嚭鎵�鏈夊弮鑰冪殑鏂囦欢锛屽琛屾キ(y猫)妯�(bi膩o)婧�(zh菙n)锛屽湅(gu贸)瀹舵(bi膩o)婧�(zh菙n)锛屽叕鍙告斂绛�锛涙绔犵瘈(ji茅)涔熻ū鍙互妯�(bi膩o)娉ㄧ偤“NA”骞跺埅闄や笅琛�銆�
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鏂囦欢 |
鎻忚堪 |
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銆婁腑鑿汉姘戝叡鍜屽湅(gu贸)钘ュ吀锛�2010骞寸増浜岄儴锛夈�嬮檮閷�XIX Q钘ュ搧寰敓鐗╁(sh铆)椹�(y脿n)瀹よ(gu墨)鑼冩寚灏�(d菐o)鍘熷墖 |
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JJF1101-2003 |
銆婄挵(hu谩n)澧冭│椹�(y脿n)瑷�(sh猫)鍌欐韩搴�銆佹韩搴︽牎婧�(zh菙n)瑕�(gu墨)鑼冦�� |
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YY0027-1990 |
銆婇浕鐔辨亽婧煿椁�(y菐ng)绠便�嬪湅(gu贸)瀹惰妤�(y猫)妯�(bi膩o)婧�(zh菙n) |
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銆婁腑鍦�(gu贸)钘ュ搧妾㈤(y脿n)妯�(bi膩o)婧�(zh菙n)鎿嶄綔瑕�(gu墨)鑼冿紙2010骞寸増锛夈�� |
4.0 绺(xi臎)
鎵�鏈夊湪鏂囦欢涓敤鍒扮殑绺(xi臎)鍙婂叾瀹氱京鎳�(y墨ng)鍒楀湪涓嬭〃涓�; 鎸夊瓧姣嶉爢搴忔帓鍒楋紱姝ょ珷绡�(ji茅)涔熻ū鍙互妯�(bi膩o)娉ㄧ偤“NA”骞跺埅闄や笅琛�銆�
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琛�(sh霉)瑾�(y菙) |
瀹氱京 |
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IQ |
Installation Qualification |
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OQ |
Operation Qualification |
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PQ |
Performance Qualification |
5.0 鐢ㄦ埗闇�姹�
浠ヤ笅鍒楀嚭浜嗕竴浜涘湪濉(xi臎)鐢ㄦ埗闇�姹傛槸闇�鑰冩叜鐨勯儴鍒�锛屽皪(du矛)浜庝笉閬╃敤鐨勯儴鍒嗗彲濉(xi臎)“NA”锛屼絾涓嶅緱鍒櫎銆�
5.1 渚涙噳(y墨ng)鍟嗚硣璩�(zh矛)
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
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URS 5.1.1 |
鐢熺敘(ch菐n)鍟嗙偤鍦�(gu贸)鍏�(n猫i)澶栬硣娣辩殑娓�(c猫)瑭﹀剙鍣ㄧ敓鐢�(ch菐n)寤犲晢锛屽叿鍌欒壇濂界殑鍞悗鏈嶅嫏(w霉)鑳藉姏锛屽湪妤�(y猫)鐣屼韩鏈夎純濂界殑鑱茶(y霉)銆� |
鏈熸湜
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5.2 浜よ波鍦板潃
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
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URS 5.2.1 |
寤ｅ窞甯傞珮鏂版妧琛�(sh霉)鐢�(ch菐n)妤�(y猫)闁�(k膩i)鐧�(f膩)鍗�(q奴)绉戝(xu茅)鍩庣憺娉拌矾5铏�(h脿o) |
蹇呴渶
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5.3 瀹夎瑕佹眰
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
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URS 5.3.1 |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鍏嶈不(f猫i)鎻愪緵鐝�(xi脿n)鍫�(ch菐ng)瀹夎瑾�(di脿o)瑭�銆� |
蹇呴渶 |
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URS 5.3.2 |
瑷�(sh猫)鍌欏畨瑁濆湪寰敓鐗╂椹�(y脿n)瀹ょ殑鍩归(y菐ng)瀹ょ挵(hu谩n)澧冩韩搴﹀湪30鈩冩垨浠ヤ笅銆備繚璀夊湴闈㈠钩鏁�銆� |
蹇呴渶 |
5.4 绯荤当(t菕ng)鍔熻兘瑕佹眰
5.4.1 绯荤当(t菕ng)瑷�(sh猫)瑷�(j矛)鐨勮(w猫i)鐢熷(xu茅)瑕佹眰
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.4.1 .1 |
瑷�(sh猫)鍌欐潗璩�(zh矛)鍜岀祼(ji茅)妲�(g貌u)銆佹车銆侀枼闁�(m茅n)銆佸鍦�銆佹瑙掋�佺剨鎺�銆佸櫞娣�
鐞冪瓑瑕佹眰绗﹀悎琛�(w猫i)鐢熷(xu茅)瑷�(sh猫)瑷�(j矛)銆� |
蹇呴渶 |
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URS5.4.1 .2 |
瑷�(sh猫)鍌欒〃闈㈠強鍏�(n猫i)閮ㄤ究浜庢竻娼�锛屼笉鑳芥湁娓呮綌姝昏 |
蹇呴渶 |
5.4.2 绯荤当(t菕ng)鍔熻兘瑕佹眰
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
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URS |
鎺ф韩鑼冨湇鍖呮嫭锛�0鈩冭嚦50鈩�锛屽伐浣滄韩搴︾偤20-40
鈩�锛屾帶婧簿搴﹁姹傜偤±1鈩�锛屾韩搴﹀潎鍕绘��±1
鈩�銆傛韩搴﹀垎杈ㄧ巼鐐�0.1鈩�銆� |
蹇呴渶 |
|
URS |
鍏锋湁4灞や笉閵归嫾闅旀澘锛屾湁寮�(qi谩ng)鍒舵�х┖姘ｅ皪(du矛)娴�銆� |
蹇呴渶 |
|
URS |
閲囩敤寰檿鐞嗘韩搴︽帶鍒跺櫒锛屾湁婧害椤ず骞跺彲瑾�(di脿o)銆� |
蹇呴渶 |
|
URS |
鍏�(n猫i)鑵斿绌嶈姹�600L鑷�800L锛涢珨绌嶇偤锛氬搴�1250mm浠ヤ笅锛岄珮搴�2000mm浠ヤ笅锛屾繁搴︼紙涓嶅付闁�(m茅n)鎶婃墜锛�900mm浠ヤ笅銆� |
蹇呴渶 |
|
URS |
鍏锋湁婧害鎺㈤牠闋�(y霉)鐣欏瓟锛堜笉寰楄ō(sh猫)鍦ㄧ┖姘ｅ惊鐠�(hu谩n)鍑洪ⅷ(f膿ng)銆侀��(j矛n)棰�(f膿ng)鍙ｅ強鍩归(y菐ng)绠卞収(n猫i)缃韩搴︽帰闋梺锛�銆� |
蹇呴渶 |
|
URS |
鎿嬫澘鍎�(y艒u)鍏堥伕鐢ㄩ�忔槑鐜荤拑鏉愯唱(zh矛)锛屽彲閫忛亷(gu貌)鎿嬫澘瑙�瀵熷煿椁�(y菐ng)绠卞収(n猫i)寰敓鐗╁煿椁�(y菐ng)鎯呮硜銆� |
鏈熸湜 |
|
URS |
鍏锋湁婧害涓婁笅闄愬牨(b脿o)璀﹀姛鑳�銆� |
蹇呴渶 |
|
URS |
鍏锋湁绋嬪簭闄嶆韩鍔熻兘锛屽彲鍦ㄨ(gu墨)瀹氭檪(sh铆)闁撳収(n猫i)闄嶅埌瑷�(sh猫)瀹氭韩搴﹀悗淇濇寔涓嶈畩锛屽叿鏈夌┖姘ｅ惊鐠�(hu谩n)鍔熻兘銆� |
鏈熸湜 |
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.5.1 |
220V锛�50Hz銆傛噳(y墨ng)鏈夌鍚堝湅(gu贸)瀹跺畨鍏�3C瑕佹眰銆� |
蹇呴渶 |
|
URS5.5.2 |
闃查潨闆�锛岄槻婕忛浕銆� |
蹇呴渶 |
5.5 闆绘埃瑕佹眰
5.6 鑷嫊(d貌ng)鎺у埗绯荤当(t菕ng)瑕佹眰
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.6.1 |
鍏锋湁婧害瓒呭嚭瑷�(sh猫)瀹氳寖鍦嶆檪(sh铆)鑷嫊(d貌ng)瑾�(di脿o)绡�(ji茅)鎺у埗鍔熻兘 |
蹇呴渶 |
5.7 鍎�琛ㄨ姹�
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绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
NA |
NA |
NA |
5.8 椹�(y脿n)璀夎姹�
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.8.1 |
鍎�鍣ㄨ兘閫氶亷(gu貌)寤ｅ窞瑷�(j矛)閲忛櫌鐨勬牎婧�(zh菙n)锛�绗﹀悎JJF1101-2003銆�YY0027-1990鐨�瑕佹眰銆� |
蹇呴渶 |
|
URS5.8.2 |
鎻愪緵IQ銆�OQ銆侀(y脿n)璀夋湇鍕�(w霉)锛屽苟涓旈(y脿n)璀夊悎鏍�銆傚繀闋堥仈(d谩)鍒�URS瑕�(gu墨)瀹氱殑闇�姹傛(bi膩o)婧�(zh菙n)锛屼緵鎳�(y墨ng)鍟嗗厛鎻愪緵椹�(y脿n)璀夋柟妗�銆� |
蹇呴渶 |
5.9 鏂囦欢瑕佹眰
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.9.1 |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鎻愪緵2浠借ō(sh猫)鍌欐搷浣滆(shu艒)鏄庡強缍(h霉)淇濋(y菐ng)鎵嬪唺(c猫)銆� |
蹇呴渶 |
|
URS5.9.2 |
渚涙噳(y墨ng)鍟嗘噳(y墨ng)鎻愪緵鍎�鍣ㄧ殑鍑哄粻鍚堟牸璀夋槑鏂囦欢銆侀(y脿n)璀夊牨(b脿o)鍛�銆� |
蹇呴渶 |
|
URS5.9.3 |
鎻愪緵鍦�(gu贸)瀹惰獚(r猫n)鍙殑閼掑畾姗�(j墨)妲�(g貌u)鎻愪緵鐨勮┎鍎�鍣ㄧ殑鏍￠(y脿n)銆� |
蹇呴渶 |
5.10 鏈嶅嫏(w霉)鑸囩董淇姹�
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鍏嶈不(f猫i)鎻愪緵鐝�(xi脿n)鍫�(ch菐ng)鎿嶄綔鍜岀董璀�(h霉)淇濋(y菐ng)鐨勫煿瑷�(x霉n)銆� |
蹇呴渶 |
|
URS5.10.2 |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鏄庣⒑瑭崇窗(x矛)鐨勪繚淇収(n猫i)瀹瑰強鏅�(sh铆)闁�銆� |
蹇呴渶 |
|
URS5.10.3 |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鎻愪緵鍞悗鏈嶅嫏(w霉)鑱�(li谩n)绯绘柟寮�銆� |
蹇呴渶 |
|
URS5.10.4 |
瑷�(sh猫)鍌欎緵鎳�(y墨ng)鍟嗘噳(y墨ng)鑳戒繚璀夌董淇�侀浂閰嶄欢鐨勪緵鎳�(y墨ng)銆� |
蹇呴渶 |
|
URS5.10.5 |
鎳�(y墨ng)鎻愪緵鑷冲皯1骞寸殑鏁存(j墨)淇濅慨锛屾瘡骞村崝(xi茅)鍔╂湰鍏徃閫�(j矛n)琛岀董璀�(h霉)鏈嶅嫏(w霉)銆備緵鎳�(y墨ng)鍟嗚兘鏍规摎(j霉)URS鎻愪緵FS銆� |
蹇呴渶 |
5.11 瀹夊叏鏂归潰瑕佹眰
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.11.1 |
瑷�(sh猫)鍌欎笂鏄撳皪(du矛)鎿嶄綔浜哄摗閫犳垚鍌峰鐨勯亱(y霉n)鍕�(d貌ng)閮ㄤ綅鎳�(y墨ng)鏈夊畨鍏ㄧ僵锛� |
蹇呴渶 |
|
URS5.11.2 |
瑷�(sh猫)鍌欓儴浣嶄换浣曚笉鑳芥湁閶掑埄鐨勯倞绶ｅ拰灏栬銆� |
蹇呴渶 |
|
URS5.11.3 |
闄ら伒瀹堝挤(qi谩ng)鐢熷叕鍙稿畨鍏ㄥ悎鍚屽収(n猫i)鐨勬渚嬪锛屽皪(du矛)涓彲浜烘皯鍏卞拰鍦�(gu贸)鍜屽唬鏉辩渷鍚勯儴闁�(m茅n)鎵�闋掑竷鐨勬湁闂�(gu膩n)瑕�(gu墨)瀹氫篃蹇呴爤浜堜互閬靛畧銆� |
蹇呴渶 |
5.12 鐠�(hu谩n)澧冩柟闈�
|
绶ㄨ櫉(h脿o) |
鍏�(n猫i)瀹� |
蹇呴渶锛忔湡鏈� |
|
URS5.12.1 |
鍣煶鍦ㄨō(sh猫)鍌�1绫冲収(n猫i)锛�65dBA锛岃ō(sh猫)鍌欏琛ㄦ韩搴︿笉澶т簬35鈩�锛屼緵鎳�(y墨ng)鍟嗘彁渚涚浉闂�(gu膩n)璀夋槑銆� |
蹇呴渶 |
|
URS5.12.2 |
鎵�閬哥敤鐨勬潗鏂欎笉寰椾娇鐢ㄧ煶妫夊強鍏跺埗鍝併�� |
蹇呴渶 |