{"id":179,"date":"2025-09-11T17:49:32","date_gmt":"2025-09-11T09:49:32","guid":{"rendered":"http:\/\/connanyy1.gotoip2.com\/?page_id=179"},"modified":"2025-09-11T17:49:33","modified_gmt":"2025-09-11T09:49:33","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0ce%e8%ae%a4%e8%af%81","status":"publish","type":"page","link":"https:\/\/www.marytest.com\/?page_id=179","title":{"rendered":"\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1"},"content":{"rendered":"\n<p>\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u6307\u4ee4\u4e3a93\/42\/EEC\uff08MDD)\uff0c\u5982\u679c\u4e3a\u5e26\u7535\u7684\u533b\u7597\u5668\u68b0\uff0c\u8fd8\u4f1a\u6d89\u53ca\u4f4e\u7535\u538b\u6307\u4ee42006\/95\/EC\uff08LVD\uff09\u6307\u4ee4\u548c\u7535\u78c1\u517c\u5bb9\u6307\u4ee42004\/108\/EC\uff08EMC\uff09\u6307\u4ee4\u3002<br>\u76f8\u5173\u7684\u7535\u6c14\u6d4b\u8bd5\u4e5f\u9700\u9001\u68c0\u6d4b\u8bd5\uff0c\u5e38\u7528\u7684\u6b27\u76df\u6807\u51c6\u6709\uff1aEN60601-1\u533b\u7528\u7535\u6c14\u8bbe\u5907\u7b2c\u4e00\u90e8\u5206\uff1a\u5b89\u5168\u901a\u7528\u8981\u6c42\uff1bEN60601-1-1\uff1bEN60601-1-2<\/p>\n\n\n\n<p><strong>\u6b27\u76df\u59d4\u5458\u4f1a\u9488\u5bf9\u533b\u7597\u4ea7\u54c1\u5236\u5b9a\u4e86\u4e09\u4e2a\u6307\u4ee4\uff1a<\/strong><br>1. &nbsp;\u6709\u6e90\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMD\uff0c 90\uff0f335\uff0fEEC\uff09\uff0c\u9002\u7528\u4e8e\u5fc3\u810f\u8d77\u640f\u5668\uff0c\u53ef\u690d\u5165\u7684\u80f0\u5c9b\u7d20\u6cf5\u7b49\u6709\u6e90\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u3002AIMD\u4e8e1993\u5e741\u67081\u65e5\u751f\u6548\u3002\u8fc7\u6e21\u622a\u6b62\u671f\u4e3a1994\u5e7412\u670831\u65e5\uff0c\u4ece1995\u5e741\u67081\u65e5\u5f3a\u5236\u5b9e\u65bd\u3002<br>2. &nbsp;\u6d3b\u4f53\u5916\u8bca\u65ad\u5668\u68b0\u6307\u4ee4\uff08IVD\uff0990\/385\/EEC\uff0c\u9002\u7528\u4e8e\u8840\u7ec6\u80de\u8ba1\u6570\u5668\uff0c\u598a\u5a20\u68c0\u6d4b\u88c5\u7f6e\u7b49\u6d3b\u4f53\u5916\u8bca\u65ad\u7528\u533b\u7597\u5668\u68b0\u3002<br>3. &nbsp;<strong>\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08Medical devices\uff0993\/42\/EEC<\/strong>\uff0c\u9002\u7528\u8303\u56f4\u5f88\u5e7f\uff0c\u5305\u62ec\u9664\u6709\u6e90\u690d\u5165\u6027\u548c\u4f53\u5916\u8bca\u65ad\u5668\u68b0\u4e4b\u5916\u7684\u51e0\u4e4e\u6240\u6709\u7684\u533b\u7597\u5668\u68b0\uff0c\u5982\u65e0\u6e90\u6027\u533b\u7597\u5668\u68b0\uff08\u6577 \u6599\u3001\u4e00\u6b21\u6027\u4f7f\u7528\u4ea7\u54c1\u3001\u63a5\u89e6\u955c\u3001\u8840\u888b\u3001\u5bfc\u7ba1\u7b49\uff09\uff1b\u4ee5\u53ca\u6709\u6e90\u6027\u533b\u7597\u5668\u68b0\uff0c\u5982\u6838\u78c1\u5171\u632f\u4eea\u3001\u8d85\u58f0\u8bca\u65ad\u548c\u6cbb\u7597\u4eea\u3001\u8f93\u6db2\u6cf5\u7b49\u3002\u8be5\u6307\u4ee4\u6709\u6b27\u76df\u59d4\u5458\u4f1a\u57281993\u5e746\u670814\u65e5\u9881\u5e03\uff0c\u5e76\u4e8e1998\u5e746\u670814\u65e5\u8d77\u5f3a\u5236\u6267\u884c\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>1.\u533b\u7597\u5668\u68b0\u4ea7\u54c12014\u5e747\u6708\u6b63\u5f0f\u7eb3\u5165RoHS 2.0 \u7ba1\u63a7\u8303\u56f4<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>2011\u5e747\u67081\u65e5\u6b27\u76df\u5728\u5176\u5b98\u65b9\u516c\u62a5\u4e0a\u6b63\u5f0f\u53d1\u5e03RoHS\u4fee\u8ba2\u6307\u4ee42011\/65\/EU(RoHS 2.0)\uff0c\u8be5\u6307\u4ee4\u4e8e2013\u5e741\u67083\u65e5\u5168\u9762\u5b9e\u65bd\u3002<br>RoHS 2.0 \u7eb3\u5165CE\u6807\u5fd7\u8981\u6c42\uff0c\u6210\u4e3a\u6b27\u76dfCE\u6807\u5fd7\u6307\u4ee4\u4e4b\u4e00\u3002\u7535\u5b50\u7535\u6c14\u4ea7\u54c1\u53ea\u6709\u5728\u7b26\u5408\u4f4e\u7535\u538b\u6307\u4ee4(LVD)\u3001\u7535\u78c1\u517c\u5bb9(EMC)\u3001\u80fd\u6e90\u76f8\u5173\u4ea7\u54c1(ErP)\u548cRoHS 2.0\u7684\u6307\u4ee4\u8981\u6c42\uff0c\u624d\u80fd\u7c98\u8d34CE\u6807\u5fd7\uff0c\u51fa\u5177\u7b26\u5408\u6027\u58f0\u660e\uff0c\u800c\u4e14RoHS 2.0\u8fd8\u540c\u65f6\u8981\u6c42\u5236\u9020\u5546\u51fa\u5177\u652f\u6491\u6027\u6280\u672f\u6587\u6863\uff0c\u5e76\u4fdd\u7559\u5341\u5e74\u3002\u7ba1\u63a7\u4ea7\u54c1\u8303\u56f4\u6269\u5927\uff0c\u65b0\u589e\u7b2c 8 \u7c7b\u533b\u7597\u8bbe\u5907\u3001\u7b2c 9 \u7c7b\u76d1\u63a7\u8bbe\u5907\u548c\u589e\u52a0\u7b2c 11 \u7c7b\u5176\u4ed6\u7535\u5b50\u7535\u6c14\u8bbe\u5907\u3002<br>\u533b\u7597\u5668\u68b0\u4ea7\u54c1RoHS 2.0\u5b9e\u65bd\u65e5\u7a0b\u8868<\/p>\n\n\n\n<p>2014\u5e747\u670822\u65e5\uff0c \u533b\u7597\u5668\u6750\u7eb3\u5165RoHS 2.0 \u7ba1\u63a7\u8303\u56f42016\u5e747\u670822\u65e5\uff0c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u8bbe\u5907\u6708\u7eb3\u5165RoHS 2.0 \u7ba1\u63a7\u8303\u56f4\u4e3b\u52a8\u690d\u5165\u5f0f\u533b\u7597\u8bbe\u5907(\u6682\u65f6\u8c41\u514d)<\/p>\n\n\n\n<p><strong>2.\u6b27\u76df\u533b\u7597\u5668\u68b0\u5b9a\u4e49\u53ca\u5206\u7c7b<\/strong>\uff1a<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u533b\u7597\u5668\u68b0\u6307\u5355\u72ec\u6216\u8005\u7ec4\u5408\u4f7f\u7528\u4e0e\u4eba\u4f53\u7684\u4eea\u5668\u3001\u8bbe\u5907\u3001\u5668\u5177\u3001\u6750\u6599\u6216\u5176\u4ed6\u7269\u54c1\uff0c\u5305\u62ec\u6240\u9700\u8981\u7684\u8f6f\u4ef6\uff1b\u5176\u9002\u7528\u65e8\u5728\u8fbe\u5230\u4e0b\u5217\u9884\u671f\u76ee\u7684\uff1a<br>1. \u5bf9\u75be\u75c5\u7684\u9884\u9632\u3001\u8bca\u65ad\u3001\u76d1\u6d4b\u3001\u6cbb\u7597\u6216\u51cf\u7f13;<br>2. \u5bf9\u53d7\u4f24\u6216\u6b8b\u969c\u7684\u8bca\u65ad\u3001\u76d1\u62a4\u3001\u6cbb\u7597\u3001\u73af\u8282\u6216\u4fee\u8865;<br>3. \u5bf9\u89e3\u5256\u6216\u751f\u7406\u8fc7\u7a0b\u7684\u7814\u7a76\u3001\u66ff\u4ee3\u3001\u8c03\u8282\uff1b<br>4. \u598a\u5a20\u63a7\u5236<br>\u533b\u7597\u5668\u68b0\u5206\u7c7b\uff1a<br>\u6b27\u76df\u628a\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5206\u4e3a\u56db\u7c7b\uff1a\u7b2c\u2160\u7c7b\u3001\u7b2c\u2161a\u7c7b\u3001\u7b2c\u2161b\u7c7b\u3001\u7b2c\u2162\u7c7b<\/p>\n\n\n\n<p><a><\/a><br><strong>3.\u533b\u7597\u5668\u68b0\/\u8bbe\u5907\u6709\u90a3\u4e9b\u8ba4\u8bc1\uff1f<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u533b\u7597\u8bbe\u5907\u4f9b\u5e94\u5546\u5fc5\u987b\u786e\u4fdd\u8bbe\u5907\u5236\u9020\u7b26\u5408\u6216\u8d85\u8fc7\u6240\u9700\u7684\u5b89\u5168\u548c\u6027\u80fd\u6807\u51c6\u3002 \u5728\u6ee1\u8db3\u8fd9\u4e9b\u4f1a\u5bf9\u8bbe\u5907\u8bbe\u8ba1\u3001\u5f00\u53d1\u3001\u6d4b\u8bd5\u3001\u5236\u9020\u3001\u5305\u88c5\u548c\u6807\u8bb0\u9020\u6210\u5f71\u54cd\u7684\u7ba1\u7406\u8981\u6c42\u4e4b\u540e\uff0c\u4ea7\u54c1\u5373\u53ef\u6295\u653e\u5e02\u573a\u3002<br>1. \u533b\u7597\u6b27\u76dfMDD\u6307\u4ee4EN\u6807\u51c6\u7684\u6d4b\u8bd5CE\u8ba4\u8bc1<br>EN\/IEC 60601-1\uff08\u4e00\u822c\u5b89\u5168\u8981\u6c42\uff09<br>EN\/IEC 60601-1-xx\uff08\u9644\u5c5e\u8981\u6c42\uff09<br>EN\/IEC 60601-2-xx\uff08\u7279\u5b9a\uff09\u7cfb\u5217\u6807\u51c6<br>\u5bf9\u533b\u7597\u8bbe\u5907\u8fdb\u884cEMC\u6d4b\u8bd5<\/p>\n\n\n\n<p>\u533b\u7597\u8bbe\u5907\u6307\u4ee4\uff0cClass I-m\uff08\u6d4b\u91cf\uff09\u3001I-s\uff08\u65e0\u83cc\uff09\u3001IIa\u3001IIb\u3001III<br>EC\u5408\u89c4\u6027\u58f0\u660e\uff1b\u7f16\u5236\u8bd5\u9a8c\u62a5\u544a\u548c\u5bf9\u6280\u672f\u6587\u4ef6\uff08MDD\u9644\u4ef6VII\uff09\u8fdb\u884c\u6240\u9700\u7684\u6587\u6863\u5316\u3002<br>EC\u7c7b\u5ba1\u6838\u8bc1\u4e66\uff08MDD\u9644\u4ef6III\uff09\u3002<br>EN ISO 13485\u5168\u9762\u8d28\u91cf\u4fdd\u8bc1\uff08MDD\u9644\u4ef6II\uff09\u3002<br>EN ISO 13485\u4ea7\u54c1\u8d28\u91cf\u4fdd\u8bc1\uff08MDD\u9644\u4ef6V\uff09\u3002<br>MDD\u9644\u4ef6VI\u4ea7\u54c1\u8d28\u91cf\u4fdd\u8bc1<br>MDD\u9644\u4ef6IV\u4e4bEC\u5ba1\u6838\u3002<\/p>\n\n\n\n<p>2. ISO13485\u7ba1\u7406\u7cfb\u7edf\u8ba4\u8bc1<br>ISO 13485:2003\u662f\u4e00\u79cd\u7528\u4e8e\u533b\u7597\u8bbe\u5907\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u3002\u82e5\u8981\u7b26\u5408\u6b27\u6d32\u7ba1\u7406\u8981\u6c42\uff0c\u9996\u5148\u8981\u7b26\u5408ISO 13485:2003\u3002ISO 13485:2003\u6709\u52a9\u4e8e\u5efa\u7acb\u4e00\u79cd\u901a\u8fc7\u7f8e\u56fdFDA\u8ba4\u8bc1\u6240\u5fc5\u9700\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u3002<br>\u5728\u6b27\u6d32\uff0c\u5728\u83b7\u51c6\u51fa\u552e\u533b\u7597\u8bbe\u5907\u4e4b\u524d\uff0c\u5fc5\u9700\u6309\u7167EEC\u6cd5\u4ee4\uff0893\/42\/EEC\uff09\u5bf9\u5176\u5408\u89c4\u6027\u8fdb\u884c\u8bc4\u4f30\u3002\u82e5\u8981\u83b7\u5f97CE\u8ba4\u8bc1\u8bc1\u4e66\u548c\u5728\u6b27\u76df\u9500\u552e\u533b\u7597\u8bbe\u5907\u7684\u8bb8\u53ef\uff0c\u5fc5\u987b\u7531\u6307\u5b9a\u673a\u6784\u6839\u636eISO 13485:2003\u548c93\/42\/EEC\u6307\u4ee4\u5bf9\u516c\u53f8\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u8fdb\u884c\u8ba4\u8bc1\u3002<\/p>\n\n\n\n<p>3. \u73af\u5883\u5408\u89c4\u6027<\/p>\n\n\n\n<p><strong>4.\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u4ea7\u54c1\u5206\u7c7b<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u505aCE\u8ba4\u8bc1\u600e\u4e48\u5206\u7c7b\u7684\uff1f\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5206\u4e3a\u51e0\u7c7b\uff1f\u5404\u7c7b\u533b\u7597\u5668\u68b0\u4ea7\u54c1CE\u8ba4\u8bc1\u600e\u4e48\u505a\uff1f\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u4ea7\u54c1\u5206\u7c7b\u89c4\u5219\uff1f<br>\u533b\u7597\u5668\u68b0\u6307\u4ee4\u9644\u5f55\u4e5d\u4e2d\u8be6\u5b9a18\u6761\u89c4\u5219\uff0c\u6309\u533b\u7597\u4ea7\u54c1\u7684\u5371\u9669\u7a0b\u5ea6\uff0c\u5c06\u4ea7\u54c1\u5206\u4e3a\u2160\u7c7b\u3001\u2161a\u7c7b\u3001\u2161b\u7c7b\u3001\u2162\u7c7b\u3002<\/p>\n\n\n\n<p>\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5206\u7c7b\u89c4\u5219\uff1a<br>1\u3001\u89c4\u5219\u5e94\u7528\u7531\u5668\u68b0\u7684\u9884\u671f\u4f7f\u7528\u76ee\u7684\u51b3\u5b9a;<br>2\u3001\u5982\u679c\u5668\u68b0\u662f\u548c\u5176\u5b83\u5668\u68b0\u914d\u5408\u4f7f\u7528\uff0c\u5206\u7c7b\u89c4\u5219\u5206\u522b\u9002\u7528\u4e8e\u6bcf\u79cd\u5668\u68b0;<br>3\u3001\u9644\u4ef6\u53ef\u4ee5\u548c\u5176\u5b83\u4e00\u8d77\u4f7f\u7528\u7684\u5668\u68b0\u5206\u5f00\u5355\u72ec\u5206\u7c7b;<br>4\u3001\u542f\u52a8\u6216\u5f71\u54cd\u67d0\u79cd\u5668\u68b0\u7684\u8f6f\u4ef6\u4e0e\u5668\u68b0\u5c5e\u4e8e\u540c\u4e00\u7c7b\u578b\u3002<\/p>\n\n\n\n<p>\u5206\u7c7b\u51c6\u5219\uff1a<br>1.\u65f6 \u95f4\uff1a \u6682\u65f6 (&lt;60\u5206\u949f)\u3001\u77ed\u671f(&lt;30\u5929)\u3001\u957f\u671f(&gt;30\u5929)<br>2.\u521b\u4f24\u6027\uff1a\u975e\u521b\u4f24\u3001\u901a\u8fc7\u5b54\u5f84\u521b\u4f24\uff0c\u5916\u79d1\u521b\u4f24 \u3001\u690d\u5165\u3002<br>3.\u9002\u7528\u4f4d\u7f6e\uff1a\u4e2d\u592e\u5faa\u73af\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff0c\u5176\u5b83\u5730\u65b9\u3002<br>4.\u80fd\u91cf\u4f9b\u5e94\uff1a\u65e0\u6e90\uff0c\u6709\u6e90\u3002<br><strong>\u89c4\u52191\uff5e4\u3001\u6240\u6709\u975e\u521b\u4f24\u6027\u5668\u68b0\u5747\u5c5e\u4e8eI\u7c7b<\/strong>\uff0c\u9664\u975e\u4ed6\u4eec\uff1a<br>\u7528\u4e8e\u50a8\u5b58\u4f53\u6db2(\u8840\u888b\u4f8b\u5916) II a\u7c7b<br>\u4e8eIla\u7c7b\u6216\u66f4\u9ad8\u7c7b\u578b\u7684\u6709\u6e90\u533b\u7597\u5668\u68b0\u7c7b II a\u7c7b<br>\u6539\u53d8\u4f53\u6db2\u6210\u5206 II a\/II b\u7c7b<br>\u4e00\u4e9b\u4f24\u53e3\u6577\u6599 II a\/II b\u7c7b<br>5. \u89c4\u52195\u3001\u4fb5\u5165\u4eba\u4f53\u5b54\u5f84\u7684\u533b\u7597\u5668\u68b0<br>\u6682\u65f6\u4f7f\u7528(\u7259\u79d1\u538b\u7f29\u6750\u6599\u3001\u68c0\u67e5\u624b\u5957) I\u7c7b<br>\u77ed\u671f\u4f7f\u7528(\u5bfc\u7ba1\u3001\u9690\u5f62\u773c\u955c) II a\u7c7b<br>\u957f\u671f\u4f7f\u7528(\u6b63\u5e38\u7259\u7ebf) II b\u7c7b<br>6. \u89c4\u52196-8\u3001\u5916\u79d1\u521b\u4f24\u6027\u5668\u68b0<br>\u518d\u4f7f\u7528\u7684\u5916\u79d1\u5668\u68b0(\u94b3\u5b50\uff0c\u65a7\u5b50) I\u7c7b<br>\u6682\u65f6\u6216\u77ed\u671f\u4f7f\u7528(\u7f1d\u5408\u9488\u3002\u5916\u79d1\u624b\u5957) 11a\u7c7b<br>\u957f\u671f\u4f7f\u7528(\u5047\u5173\u8282\uff0c\u773c\u5185\u6676\u4f53) II b\u7c7b<br>\u4e0e\u4e2d\u592e\u5faa\u73af\u7cfb\u7edf(CCS)\u6216\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u63a5\u89e6\u7684\u5668\u68b0 III\u7c7b<br>7.&nbsp;\u89c4\u52199\u3001\u7ed9\u4e88\u6216\u4ea4\u6362\u80fd\u91cf\u7684\u6cbb\u7597\u5668\u68b0 II a\u7c7b<br>(\u808c\u8089\u523a\u6fc0\u5668\u3001\u7535\u94bb\u3001\u76ae\u80a4\u5149\u7597\u673a\u3001\u52a9\u542c\u5668)\u4e00\u4e00\u79cd\u6f5c\u5728\u5371\u9669\u65b9\u5f0f\u5de5\u4f5c\u7684 II b\u7c7b<br>(\u5a74\u513f\u57f9\u517b\u7bb1\u3001\u9ad8\u9891\u7535\u5200\u3001\u8d85\u58f0\u788e\u77f3\u673a\u3001X\u5149\u673a)<br>8.\u89c4\u521910\u3001\u8bca\u65ad\u5668\u68b0<br>\u63d0\u4f9b\u80fd\u91cf(\u6838\u78c1\u5171\u632f\uff0c\u8d85\u58f0\u8bca\u65ad\u4eea) II a\u7c7b<br>\u8bca\u65ad\/\u76d1\u89c6\u4f53\u5185\u653e\u5c04\u836f\u7269\u5206\u5e03 II a\u7c7b<br>(r\u7167\u76f8\u673a\u3001\u6b63\u7535\u5b50\u53d1\u5c04\u6210\u50cf\u4eea)<br>\u8bca\u65ad\/\u76d1\u89c6\u751f\u7406\u529f\u80fd(\u5fc3\u7535\u56fe\u3001\u8111\u7535\u56fe) II a\u7c7b<br>\u5371\u9669\u60c5\u51b5\u4e0b\u76d1\u89c6\u751f\u7406\u529f\u80fd II b\u7c7b<br>(\u624b\u672f\u4e2d\u7684\u8840\u6c14\u5206\u6790\u4eea)<br>\u53d1\u51fa\u7535\u79bb\u8f90\u5c04(X\u5c04\u7ebf\u8bca\u65ad\u8bae) II b\u7c7b<br>9.\u89c4\u521911 \u63a7\u5236\u836f\u7269\u6216\u5176\u4ed6\u7269\u8d28\u8fdb\u51fa\u4eba\u4f53\u7684\u6709\u6e90\u5668\u68b0 II a\u7c7b<br>(\u5438\u5f15\u8bbe\u5907\u3001\u4f9b\u7ed9\u6cf5)<br>\u5982\u4ee5\u4e00\u79cd\u6f5c\u5728\u5371\u9669\u65b9\u5f0f\u5de5\u4f5c II b\u7c7b<br>(\u9ebb\u9189\u673a\u3001\u547c\u5438\u673a\u3001\u900f\u6790\u673a\u3001\u9ad8\u538b\u6c27\u8231)<br>10.\u89c4\u521912.\u6240\u6709\u5176\u4ed6\u6709\u6e90\u533b\u7597\u5668\u68b0\u5c5e\u4e8eI\u7c7b<br>(\u89c2\u5bdf\u706f\u3001\u7259\u79d1\u6905\u3001\u8f6e\u6905\u3001\u7259\u79d1\u7528\u6cbb\u7597\u706f\u3001\u8bb0\u5f55\u5904\u7406\u89c2\u5bdf\u8bca\u65ad\u56fe\u8c61\u7528\u7684\u6709\u6e90\u5668\u68b0)<br>11.\u89c4\u521913\u3001\u4e0e\u533b\u7528\u7269\u8d28\u7ed3\u5408\u7684\u5668\u68b0(\u542b\u6740\u7cbe\u5b50\u7684\u907f\u5b55\u5957\u3001\u542b\u6297\u751f\u7d20\u7684\u7259\u9ad3\u6750\u6599) III\u7c7b<br>12.\u89c4\u521914\u3001\u907f\u5b55\u7528\u5177(\u907f\u5b55\u5957\u3001\u5b50\u5bab\u5e3d II b\u7c7b ) II b\/III\u7c7b (\u5b50\u5bab\u5185\u907f\u5b55\u5668 III\u7c7b)<br>13.\u89c4\u521915\u3001\u6e05\u6d17\u6216\u6d88\u6bd2\u7684\u5668\u68b0:\u3000\u3000\u533b\u7597\u5668\u68b0(\u5185\u7aa5\u955c\u6d88\u6bd2) II a\u7c7b\u3001\u63a5\u89e6\u955c(\u6d88\u6bd2\u6db2\u3001\u62a4\u7406\u6db2) II a\u7c7b<br>14.\u89c4\u521916\u3001\u7528\u4e8e\u8bb0\u5f55X\u5c04\u7ebf\u56fe\u8c61\u7684\u5668\u68b0(X\u5149\u7247) II a\u7c7b<br>15.\u89c4\u521917\u3001\u5229\u7528\u52a8\u7269\u7ec4\u7ec7\u7684\u5668\u68b0(\u751f\u7269)\u5fc3\u810f\u74e3\u819c\u3001\u80a0\u7ebf\u3001\u80f6\u539f) III\u7c7b<br>16.\u89c4\u521918\u3001\u8840\u888b II b\u7c7b<\/p>\n\n\n\n<p><strong>5.\u533b\u7597\u5668\u68b0\u4ea7\u54c1CE\u8ba4\u8bc1\u51c6\u5907\u5de5\u4f5c<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u533b\u7597\u5668\u68b0\u4ea7\u54c1CE\u8ba4\u8bc1\u5e94\u8be5\u51c6\u5907\u4ec0\u4e48\uff1f\u8981\u505a\u4ec0\u4e48\u51c6\u5907\u5de5\u4f5c\uff1f\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u600e\u6837\u505aCE\u8ba4\u8bc1\uff1f<br>1. \u533b\u7597\u5668\u68b0\u4ea7\u54c1\u8981\u987a\u5229\u901a\u8fc7\u6b27\u76dfCE\u8ba4\u8bc1\uff0c\u9700\u8981\u505a\u597d\u4e09\u65b9\u9762\u7684\u5de5\u4f5c\uff1a<br>\u7b2c\u4e00\uff0c\u6536\u96c6\u4e0e\u8ba4\u8bc1\u4ea7\u54c1\u6709\u5173\u7684\u6b27\u76df\u6280\u672f\u6cd5\u89c4\u548c\u6b27\u76df(EN)\u6807\u51c6\uff0c\u901a\u8fc7\u6d88\u5316\u3001\u5438\u6536\u3001\u7eb3\u5165\u4f01\u4e1a\u4ea7\u54c1\u6807\u51c6\u3002\u4e0a\u6d77\u66fc\u52b1\u60a8\u8eab\u8fb9\u7684\u8ba4\u8bc1\u4e13\u5bb6\uff0c\u4e13\u4e1a\u89e3\u7b54\u6280\u672f\u6cd5\u89c4\u548c\u6807\u51c6\uff0c\u4e3a\u60a8\u8282\u7701\u7cbe\u529b\u548c\u65f6\u95f4\u3002<br>\u7b2c\u4e8c\uff0c\u4f01\u4e1a\u4e25\u683c\u6309\u7167\u4ee5\u4e0a\u4ea7\u54c1\u6807\u51c6\u7ec4\u7ec7\u751f\u4ea7\uff0c\u4e5f\u5c31\u662f\u628a\u4e0a\u8ff0\u6280\u672f\u6cd5\u89c4\u548cEN\u6807\u51c6\u7684\u8981\u6c42\uff0c\u8d2f\u5f7b\u5230\u4f01\u4e1a\u4ea7\u54c1\u7684\u8bbe\u8ba1\u5f00\u53d1\u548c\u751f\u4ea7\u5236\u9020\u7684\u5168\u8fc7\u7a0b\u3002<br>\u7b2c\u4e09\uff0c\u4f01\u4e1a\u5fc5\u987b\u6309ISO9000+ISO13485\u6807\u51c6\u5efa\u548c\u7ef4\u62a4\u8d28\u91cf\u4f53\u7cfb\uff0c\u5e76\u53d6\u5f97ISO9000+ISO13485\u8ba4\u8bc1\u3002\u9488\u5bf9\u4e0d\u540c\u7684\u4ea7\u54c1\u91c7\u7528\u7684\u65b9\u5f0f\u4e0d\u540c\uff0c\u5177\u4f53\u53c2\u770b\u4e0b\u9762\u7684\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5206\u7c7b<br>2. \u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u5e94\u9075\u5faa\u7684\u6b27\u76df\u6280\u672f\u6cd5\u89c4\u548cEN\u6807\u51c6\uff1a<br>\u5bf9\u4e8e\u76ee\u524d\u6b27\u76df\u5df2\u53d1\u5e03\u768418\u7c7b\u5de5\u4e1a\u4ea7\u54c1\u6307\u4ee4\uff0c\u4ece\u8fd9\u4e9b\u6307\u4ee4\u7684\u7ed3\u6784\u770b\uff0c\u5b83\u4eec\u53ef\u5206\u4e3a\u5782\u76f4\u6307\u4ee4\u548c\u6c34\u5e73\u6307\u4ee4\u3002\u5782\u76f4\u6307\u4ee4\u662f\u4ee5\u5177\u4f53\u4ea7\u54c1\u4e3a\u5bf9\u8c61\uff0c\u5982\u533b\u7597\u5668\u68b0\u6307\u4ee4;\u6c34\u5e73\u6307\u4ee4\u9002\u7528\u4e8e\u5404\u79cd\u4ea7\u54c1\u7cfb\u5217\uff0c\u5982\u7535\u78c1\u517c\u5bb9\u6027\u6307\u4ee4\uff0c\u5b83\u9002\u7528\u4e8e\u5168\u90e8\u7535\u5668\u53ca\u7535\u5b50\u96f6\u90e8\u4ef6\u4ea7\u54c1\u3002<br>\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\uff0c\u9002\u7528\u7684\u6307\u4ee4\u6709\u7b2c\u5341\u56db\u9879\u3001\u7b2c\u4e00\u9879\u548c\u7b2c\u4e94\u9879\uff0c\u5373\uff1a93\/42\/EEC\u533b\u7597\u5668\u68b0\u6307\u4ee4\u3001\u4f4e\u7535\u538b\u6307\u4ee42006\/95\/EC\uff08LVD\uff09\u6307\u4ee4\u548c\u7535\u78c1\u517c\u5bb9\u6307\u4ee42004\/108\/EC\uff08EMC\uff09\u6307\u4ee4\u3002<br>\u652f\u6301\u8fd9\u4e9b\u6307\u4ee4\u7684\u6b27\u76df\u6807\u51c6\u662f\uff1a<br>(1)EN60601-1\u533b\u7528\u7535\u6c14\u8bbe\u5907\u7b2c\u4e00\u90e8\u5206\uff1a\u5b89\u5168\u901a\u7528\u8981\u6c42;<br>(2)EN60601-1-1\u533b\u7528\u7535\u6c14\u8bbe\u5907\u7b2c\u4e00\u90e8\u5206\uff1a\u5b89\u5168\u901a\u7528\u8981\u6c42\u53ca\u7b2c\u4e00\u53f7\u4fee\u6b63;<br>(3)EN60601-2-11\u533b\u7528\u7535\u6c14\u8bbe\u5907\u7b2c\u4e8c\u90e8\u5206\uff1a\u03b3\u5c04\u675f\u6cbb\u7597\u8bbe\u5907\u5b89\u5168\u4e13\u7528\u8981\u6c42;<br>(4)EN60601-1-2\u533b\u7528\u7535\u6c14\u8bbe\u5907\u7b2c\u4e00\u90e8\u5206\uff1a\u5b89\u5168\u901a\u7528\u8981\u6c421.2\u8282\u5e76\u884c\u6807\u51c6\u7535\u78c1\u517c\u5bb9\u6027\u2014\u2014\u8981\u6c42\u548c\u6d4b\u8bd5\u3002\u5176\u4e2d\u7b2c(1)\u3001(2)\u3001(3)\u9879\u6807\u51c6\u662f\u4f3d\u739b\u5200\u4f4e\u7535\u538b(LVD)\u6d4b\u8bd5\u7684\u4f9d\u636e\uff1a\u7b2c(4)\u9879\u6807\u51c6\u662f\u4f3d\u739b\u5200\u7535\u78c1\u517c\u5bb9\u6027(EMC)\u6d4b\u8bd5\u7684\u4f9d\u636e\u3002<br>3.\u3000\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u7a0b\u5e8f\u3001\u5185\u5bb9<br>\u6b27\u76df\u628a\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5206\u4e3a\u56db\u7c7b\uff0c\u5373\uff1a\u7b2c\u2160\u7c7b\u3001\u7b2c\u2161a\u7c7b\u3001\u7b2c\u2161b\u7c7b\u3001\u7b2c\u2162\u7c7b\u3002<br>\u7b2c\u2160\u7c7b\u4ea7\u54c1\u8981\u52a0\u8d34CE\u6807\u5fd7\uff0c\u53ef\u91c7\u53d6\u81ea\u884c\u5ba3\u544a\u7684\u65b9\u5f0f\u3002\u5373\u5382\u5546\u7f16\u5236\u4ea7\u54c1\u7684\u6280\u672f\u6587\u4ef6\u6863\u6848\uff0c\u540c\u65f6\u81ea\u884c\u6309\u6709\u5173EN\u6807\u51c6\u5bf9\u4ea7\u54c1\u8fdb\u884c\u6d4b\u8bd5\u6216\u59d4\u6258\u6709\u80fd\u529b\u7684\u8bd5\u9a8c\u5ba4\u8fdb\u884c\u6d4b\u8bd5\u5408\u683c\u3002 &nbsp; &nbsp; &nbsp; \u7b2c\u2161a\u7c7b\u3001\u7b2c\u2161b\u7c7b\u3001\u7b2c\u2162\u7c7b\u4ea7\u54c1\u8981\u52a0\u8d34CE\u6807\u5fd7\uff0c\u5219\u5fc5\u987b\u7531\u6b27\u76df\u6307\u5b9a\u7684\u9a8c\u8bc1\u673a\u6784\u9a8c\u8bc1\u3002\u6b27\u76df\u8fd8\u89c4\u5b9a\uff0c\u8fd9\u51e0\u7c7b\u4ea7\u54c1\u83b7\u5f97CE\u8ba4\u8bc1\u7684\u5148\u51b3\u6761\u4ef6\u662f\u5236\u9020\u5382\u9700\u80fd\u8fc7ISO9000+ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\uff0c\u53d6\u5f97ISO9000+ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u8bc1\u4e66\uff0c\u4e14\u8bc1\u4e66\u7684\u9881\u53d1\u5355\u4f4d\u5e94\u4e3a\u6b27\u76df\u8ba4\u53ef\u7684\u8ba4\u8bc1\u673a\u6784\u3002ISO9000+ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u548cCE\u8ba4\u8bc1\u53ef\u540c\u65f6\u8fdb\u884c\uff0c\u4f46CE\u8bc1\u4e66\u5fc5\u987b\u5f85ISO9000+ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u901a\u8fc7\u540e\uff0c\u65b9\u53ef\u4e88\u4ee5\u9881\u53d1\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u6307\u4ee4\u4e3a93\/42\/EEC\uff08MDD)\uff0c\u5982\u679c\u4e3a\u5e26\u7535\u7684\u533b\u7597\u5668\u68b0\uff0c\u8fd8\u4f1a\u6d89\u53ca\u4f4e\u7535\u538b\u6307\u4ee42006&hellip; <\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-179","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/pages\/179","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marytest.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=179"}],"version-history":[{"count":1,"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/pages\/179\/revisions"}],"predecessor-version":[{"id":181,"href":"https:\/\/www.marytest.com\/index.php?rest_route=\/wp\/v2\/pages\/179\/revisions\/181"}],"wp:attachment":[{"href":"https:\/\/www.marytest.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}