鑸堝绱呭绶氭韩搴﹁▓CE瑾嶈瓑杈︾悊姗熸(g貌u)
椤嶆韩QIANG EN 60601姝愮洘CE瑾嶈瓑鎵€闇€璨荤敤
銆€銆€椤嶆韩QIANG EN 60601姝愮洘CE瑾嶈瓑鎵€闇€璨荤敤锛岄婧�QIANG 鍑哄彛姝愮洘鍦嬪闇€瑕侀€茶CE瑾嶈瓑锛屽煼(zh铆)琛岀殑妯欐簴鏄�EN 60601锛屾繁鍦宠▕绉戝晢鍝佹娓妲�(g貌u)鍙互骞姪浼佹キ(y猫)瑙f焙椤嶆韩QIANG CE瑾嶈瓑鐩搁棞闆i锛屼笅闈㈤毃钁楀皬绶ㄤ竴璧蜂締鐪嬬湅鏇村妾㈡脯瑾嶈瓑瑭虫儏鍚�锛�
銆€銆€椤嶆韩QIANG 锛堢磪澶栫窔娓韩鍎€锛夐嚌灏嶉噺娓汉楂旈婧熀婧栬ō瑷�锛屼娇鐢ㄩ潪甯哥啊鍠�銆佹柟渚�銆�1绉掑彲婧栫⒑娓韩锛岀劇閻冲皠榛烇紝鍏嶉櫎灏嶇溂鐫涗箣娼涘湪鍌峰锛屼笉闇€鎺ヨЦ浜洪珨鐨啔锛岄伩鍏嶄氦鍙夋劅鏌�锛屼竴閸垫脯婧紝鎺掓煡娴佹劅銆傞仼鍚堝搴敤鎴�銆佽硴椁�銆佸湒鏇搁え銆佸ぇ鍨嬩紒浜嬫キ(y猫)鍠綅锛屼篃鍙互鐢ㄤ簬閱�(y墨)闄�銆佸鏍°€佹捣闂�銆佹鍫寸瓑缍滃悎鎬у牬鎵€锛岄倓鍙互鎻愪緵绲﹂啱(y墨)鍕欎汉鍝″湪瑷烘墍浣跨敤銆�
銆€銆€EN 60601鏄竴濂楁婧栫郴鍒�锛屽叾鑼冨湇娑佃搵闆诲瓙閱�(y墨)鐧傚櫒姊板強绯荤当(t菕ng)鐨勫畨鍏ㄣ€佸熀鏈€ц兘鍜岄浕纾佸吋瀹规€�銆傚畠寰炴妧琛撲笂璎涚瓑鍚屼簬鍦嬮殯妯欐簴IEC 60601锛� 瑭茬郴鍒楃敱70澶氫唤鐛ㄧ珛鐨勬婧栫祫鎴愩€�
銆€銆€鈥�绗�1閮ㄥ垎鈥�妯欐簴EN 60601-1娑佃搵閬╃敤浜庢墍鏈夐浕瀛愰啱(y墨)鐧傚櫒姊扮殑鍩烘湰瀹夊叏鍜屾€ц兘锛�鈥�绗�2閮ㄥ垎鈥�鎴�鈥�鐗规畩鈥�妯欐簴鍓囨兜钃嬮仼鐢ㄤ簬鐗瑰畾鐢�(ch菐n)鍝佺兢鐨勮姹傦紙濡傞嚌灏嶆縺鍏夐啱(y墨)鐧傚櫒姊扮殑EN 60601-2-22锛�銆�EN 60601-1閬╃敤浜庢墍鏈夐浕瀛愰啱(y墨)鐧傚櫒姊板拰闆诲瓙閱�(y墨)鐧傜郴绲�(t菕ng)銆傛婧栦腑灏囬浕瀛愰啱(y墨)鐧傚櫒姊板畾缇╃偤鍚湁鎳夌敤閮ㄤ欢銆佹垨?q奴)鈷涜姲绺介瑹f鑷�/鑷偅鑰�銆佹垨妾㈡脯姝ょó鍌抽仦鑷�/鑷偅鑰呰兘閲忕殑闆诲瓙瑷倷銆�
銆€銆€EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential perbance
銆€銆€EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perbance - Collateral Standard: Electromagnetic disturbances - Requirementsand tests
銆€銆€EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential perbance - Collateral standard: Usability
銆€銆€椤嶆韩QIANG EN 60601姝愮洘CE瑾嶈瓑鎵€闇€璨荤敤锛屼竴鑸瓙鐩�CE瑾嶈瓑璨荤敤鍦ㄥ咕鍗冨埌骞捐惉涓嶇瓑锛岄渶瑕佺湅鍋氭瓙鐩熻獚璀夌殑鐢�(ch菐n)鍝佹槸浠€涔�锛岄啱(y墨)鐧傚櫒姊扮敘(ch菐n)鍝佹瓙鐩�CE瑾嶈瓑璨荤敤鏈冩瘮杓冮珮锛屾繁鍦崇珛瑷婃娓妲�(g貌u)寰炰簨妾㈡脯瑾嶈瓑琛屾キ(y猫)鍗佷綑骞�锛屽公鍔╀紒妤�(y猫)瑙f焙鐪惧妾㈡脯瑾嶈瓑闆i锛佸鎮ㄦ湁妾㈡脯瑾嶈瓑杈︾悊闇€姹傛杩庢偍
椤嶆韩QIANG锛堢磪澶栫窔娓韩鍎€锛夐嚌灏嶉噺娓汉楂旈婧熀婧栬ō瑷�锛屼娇鐢ㄩ潪甯哥啊鍠�銆佹柟渚�銆�1绉掑彲婧栫⒑娓韩锛岀劇閻冲皠榛�锛屽厤闄ゅ皪鐪肩潧涔嬫經鍦ㄥ偡瀹�锛屼笉闇€鎺ヨЦ浜洪珨鐨啔锛岄伩鍏嶄氦鍙夋劅鏌�锛屼竴閸垫脯婧紝鎺掓煡娴佹劅銆�
椤嶆韩QIANG宸ヤ綔鍘熺悊:浠讳綍鐗╅珨鍦ㄩ珮浜庣禃灏嶉浂搴�(-273鈩�)浠ヤ笂鏅傞兘鏈冨悜澶栫櫦(f膩)鍑虹磪澶栫窔,椤嶆韩QIANG閫氶亷鍌虫劅鍣ㄦ帴鏀剁磪澶栫窔锛屽緱鍑烘劅鎳夋韩搴︽暩(sh霉)鎿�(j霉)銆�
FDA灏嶉啱(y墨)鐧傚櫒姊扮殑绠$悊閫氶亷鍣ㄦ鑸囨斁灏�JIANG搴蜂腑蹇冿紙CDRH锛夐€茶鐨�锛屼腑蹇冪洠(ji膩n)鐫i啱(y墨)鐧傚櫒姊扮殑鐢熺敘(ch菐n)銆佸寘瑁�銆佺稉(j墨ng)閵峰晢閬靛畧娉曞緥涓嬮€茶缍�(j墨ng)鐕熸椿鍕�銆傞啱(y墨)鐧傚櫒姊拌寖鍦嶅緢寤�锛屽皬鍒伴啱(y墨)鐢ㄦ墜濂�锛屽ぇ鑷冲績鑷熻捣鍗氬櫒锛屽潎鍦�FDA鐩�(ji膩n)鐫d箣涓嬶紝鏍规摎(j霉)閱�(y墨)鐧傜敤閫斿拰灏嶄汉楂斿彲鑳界殑鍌峰锛�FDA灏囬啱(y墨)鐧傚櫒姊板垎鐐�鈪�銆�鈪�銆�鈪�椤烇紝瓒婇珮椤炲垾鐩�(ji膩n)鐫h秺澶�