{"id":4347,"date":"2025-09-04T13:58:23","date_gmt":"2025-09-04T05:58:23","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4347"},"modified":"2025-09-04T13:58:23","modified_gmt":"2025-09-04T05:58:23","slug":"%e6%9c%80%e6%96%b0%e6%ac%a7%e7%9b%9f%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%95%e8%a7%84%e7%9b%ae%e5%bd%95","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4347","title":{"rendered":"\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55"},"content":{"rendered":"

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u662f\u5f53\u524d\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5173\u6ce8\u7684\u7126\u70b9\uff0c\u5b83\u4ee3\u8868\u4e86\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f53\u7cfb\u7684\u91cd\u5927\u53d8\u9769\u3002<\/p>\n<\/p>\n

\u8fd9\u4e00\u5168\u65b0\u7684\u6cd5\u89c4\u6846\u67b6\u65e8\u5728\u5e94\u5bf9\u65e5\u76ca\u590d\u6742\u7684\u533b\u7597\u6280\u672f\u73af\u5883\u548c\u65e5\u76ca\u589e\u957f\u7684\u5168\u7403\u5e02\u573a\u6311\u6218\uff0c\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6807\u51c6\u3002<\/p>\n<\/p>\n

\u4e00\u3001\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u6982\u8ff0<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u5373\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4\uff08MDR\uff09\uff0c\u5df2\u4e8e2021\u5e745\u670826\u65e5\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u3002<\/p>\n<\/p>\n

MDR\u7684\u51fa\u53f0\u80cc\u666f\u6e90\u4e8e\u4e00\u7cfb\u5217\u91cd\u5927\u7684\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff0c\u8fd9\u4e9b\u4e8b\u4ef6\u66b4\u9732\u4e86\u65e7\u6307\u4ee4\u4f53\u7cfb\u4e0b\u7684\u76d1\u7ba1\u6f0f\u6d1e\u3002<\/p>\n<\/p>\n

\u65b0\u6cd5\u89c4\u663e\u8457\u6269\u5927\u4e86\u76d1\u7ba1\u8303\u56f4\uff0c\u63d0\u9ad8\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u7684\u8981\u6c42\uff0c\u5e76\u5f15\u5165\u4e86\u66f4\u4e25\u683c\u7684\u900f\u660e\u5ea6\u89c4\u5219\u3002<\/p>\n<\/p>\n

\u4e8c\u3001\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u7684\u6838\u5fc3\u53d8\u5316<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u7684\u6838\u5fc3\u53d8\u5316\u4f53\u73b0\u5728\u591a\u4e2a\u5c42\u9762\uff0c\u5bf9\u5236\u9020\u5546\u3001\u516c\u544a\u673a\u6784\u548c\u60a3\u8005\u90fd\u4ea7\u751f\u4e86\u6df1\u8fdc\u5f71\u54cd\u3002<\/p>\n<\/p>\n

\u9996\u5148\uff0c\u5668\u68b0\u7684\u5206\u7c7b\u89c4\u5219\u66f4\u4e3a\u4e25\u683c\uff0c\u8bb8\u591a\u539f\u672c\u5c5e\u4e8e\u4f4e\u98ce\u9669\u7c7b\u522b\u7684\u4ea7\u54c1\u73b0\u5728\u88ab\u91cd\u65b0\u5212\u5206\u4e3a\u66f4\u9ad8\u98ce\u9669\u7c7b\u522b\uff0c\u8fd9\u610f\u5473\u7740\u5b83\u4eec\u9700\u8981\u6ee1\u8db3\u66f4\u82db\u523b\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\u3002<\/p>\n<\/p>\n

\u5176\u6b21\uff0c\u5bf9\u4e34\u5e8a\u6570\u636e\u7684\u8981\u6c42\u7a7a\u524d\u63d0\u9ad8\uff0c\u8981\u6c42\u5236\u9020\u5546\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u9057\u7559\u5668\u68b0\uff0c\u63d0\u4f9b\u6301\u7eed\u66f4\u65b0\u7684\u4e34\u5e8a\u8bc1\u636e\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0c\u65b0\u89c4\u5f15\u5165\u4e86\u552f\u4e00\u7684\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\uff0c\u65e8\u5728\u5b9e\u73b0\u5668\u68b0\u5728\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4ece\u800c\u5728\u53d1\u751f\u5b89\u5168\u95ee\u9898\u65f6\u80fd\u591f\u8fc5\u901f\u91c7\u53d6\u884c\u52a8\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u533b\u7597\u5668\u68b0\u5206\u7c7b\u89c4\u5219\u7684\u91cd\u5927\u8c03\u6574<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u5bf9\u4ea7\u54c1\u7684\u5206\u7c7b\u89c4\u5219\u8fdb\u884c\u4e86\u91cd\u5927\u8c03\u6574\uff0c\u8fd9\u662f\u5236\u9020\u5546\u9762\u4e34\u7684\u9996\u8981\u6311\u6218\u4e4b\u4e00\u3002<\/p>\n<\/p>\n

\u4f8b\u5982\uff0c\u67d0\u4e9b\u7528\u4e8e\u7eb3\u7c73\u6750\u6599\u7684\u5668\u68b0\u3001\u5177\u6709\u8bca\u65ad\u6216\u6cbb\u7597\u529f\u80fd\u7684\u8f6f\u4ef6\uff08SaMD\uff09\u4ee5\u53ca\u67d0\u4e9b\u690d\u5165\u5668\u68b0\u7684\u5206\u7c7b\u90fd\u53d1\u751f\u4e86\u53d8\u5316\u3002<\/p>\n<\/p>\n

\u8fd9\u4e9b\u8c03\u6574\u610f\u5473\u7740\u8bb8\u591a\u5236\u9020\u5546\u5fc5\u987b\u91cd\u65b0\u8bc4\u4f30\u5176\u4ea7\u54c1\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u5e76\u636e\u6b64\u51c6\u5907\u76f8\u5e94\u7684\u6280\u672f\u6587\u4ef6\u548c\u7b26\u5408\u6027\u58f0\u660e\uff0c\u6574\u4e2a\u8fc7\u7a0b\u9700\u8981\u6295\u5165\u5927\u91cf\u7684\u65f6\u95f4\u548c\u8d44\u6e90\u3002<\/p>\n<\/p>\n

\u56db\u3001\u5bf9\u7ecf\u6d4e\u8fd0\u8425\u5546\uff08\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u3001\u5206\u9500\u5546\uff09\u7684\u65b0\u8d23\u4efb<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u660e\u786e\u5e76\u5f3a\u5316\u4e86\u4f9b\u5e94\u94fe\u4e2d\u6240\u6709\u7ecf\u6d4e\u8fd0\u8425\u5546\u7684\u8d23\u4efb\uff0c\u6784\u5efa\u4e86\u66f4\u5168\u9762\u7684\u8d23\u4efb\u94fe\u3002<\/p>\n<\/p>\n

\u5236\u9020\u5546\u627f\u62c5\u7740\u6700\u4e3b\u8981\u7684\u8d23\u4efb\uff0c\u5fc5\u987b\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408MDR\u8981\u6c42\uff0c\u5e76\u62e5\u6709\u8d1f\u8d23\u6cd5\u89c4\u7b26\u5408\u6027\u7684\u4eba\u5458\uff08PRRC\uff09\u3002<\/p>\n<\/p>\n

\u8fdb\u53e3\u5546\u548c\u5206\u9500\u5546\u5219\u9700\u9a8c\u8bc1\u5236\u9020\u5546\u662f\u5426\u5df2\u5b8c\u6210\u5fc5\u8981\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\uff0c\u786e\u4fdd\u5668\u68b0\u5177\u6709CE\u6807\u5fd7\u5e76\u9644\u6709\u6240\u9700\u6587\u4ef6\uff0c\u4ed6\u4eec\u7684\u89d2\u8272\u4ece\u7b80\u5355\u7684\u7269\u6d41\u5546\u8f6c\u53d8\u4e3a\u76d1\u7ba1\u94fe\u4e0a\u7684\u5173\u952e\u4e00\u73af\u3002<\/p>\n<\/p>\n

\u4e94\u3001\u4e34\u5e8a\u8bc4\u4ef7\u4e0e\u4e0a\u5e02\u540e\u76d1\u7763\u7684\u66f4\u9ad8\u8981\u6c42<\/strong><\/p>\n

\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u548c\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u8ba1\u5212\u662f\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u4e2d\u5907\u53d7\u5173\u6ce8\u7684\u4e24\u4e2a\u90e8\u5206\u3002<\/p>\n<\/p>\n

M\u8981\u6c42\u4e34\u5e8a\u8bc4\u4ef7\u6210\u4e3a\u4e00\u4e2a\u6301\u7eed\u7684\u8fc7\u7a0b\uff0c\u8d2f\u7a7f\u5668\u68b0\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u5728\u9996\u6b21\u4e0a\u5e02\u65f6\u8fdb\u884c\u3002<\/p>\n<\/p>\n

\u5236\u9020\u5546\u5fc5\u987b\u5236\u5b9a\u4e25\u683c\u7684\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\uff0c\u4e3b\u52a8\u6536\u96c6\u5e76\u5206\u6790\u5176\u5668\u68b0\u5728\u771f\u5b9e\u4e16\u754c\u4e2d\u4f7f\u7528\u7684\u6570\u636e\uff0c\u5e76\u5b9a\u671f\u66f4\u65b0\u5b89\u5168\u4e0e\u6027\u80fd\u603b\u7ed3\u62a5\u544a\uff08SSP\uff09\uff0c\u53ca\u65f6\u5411\u4e3b\u7ba1\u5f53\u5c40\u62a5\u544a\u4efb\u4f55\u4e25\u91cd\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\u3002<\/p>\n<\/p>\n

\u516d\u3001Eudamed\u6570\u636e\u5e93\u4e0e\u900f\u660e\u5316\u8d8b\u52bf<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u65e8\u5728\u901a\u8fc7\u5efa\u7acb\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08Eudamed\uff09\u6765\u6781\u5927\u63d0\u5347\u76d1\u7ba1\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n

\u8be5\u6570\u636e\u5e93\u5c06\u96c6\u4e2d\u6536\u5f55\u533b\u7597\u5668\u68b0\u7684UDI\u4fe1\u606f\u3001\u516c\u544a\u673a\u6784\u8bc1\u4e66\u3001\u4e34\u5e8a\u8c03\u67e5\u3001 vigilance\u62a5\u544a\u4ee5\u53ca\u7ecf\u6d4e\u8fd0\u8425\u5546\u7b49\u4fe1\u606f\uff0c\u5e76\u5411\u516c\u4f17\u5f00\u653e\u5927\u90e8\u5206\u6570\u636e\u3002<\/p>\n<\/p>\n

\u8fd9\u610f\u5473\u7740\u60a3\u8005\u3001\u533b\u7597\u4e13\u4e1a\u4eba\u58eb\u548c\u7814\u7a76\u4eba\u5458\u5c06\u80fd\u591f\u83b7\u53d6\u66f4\u591a\u5173\u4e8e\u5668\u68b0\u5b89\u5168\u6027\u548c\u6027\u80fd\u7684\u4fe1\u606f\uff0c\u4ece\u800c\u505a\u51fa\u66f4\u660e\u667a\u7684\u51b3\u7b56\u3002<\/p>\n<\/p>\n

\u4e03\u3001\u5bf9\u5236\u9020\u5546\u548c\u884c\u4e1a\u7684\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u9762\u5bf9\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u5e26\u6765\u7684\u6df1\u8fdc\u53d8\u9769\uff0c\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u6b63\u9762\u4e34\u4e25\u5cfb\u7684\u6311\u6218\uff0c\u5305\u62ec\u5408\u89c4\u6210\u672c\u5927\u5e45\u4e0a\u5347\u3001\u516c\u544a\u673a\u6784\u8d44\u6e90\u7d27\u5f20\u4ee5\u53ca\u8ba4\u8bc1\u65f6\u95f4\u5ef6\u957f\u3002<\/p>\n<\/p>\n

\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\u9700\u8981\u5236\u9020\u5546\u91c7\u53d6\u79ef\u6781\u4e3b\u52a8\u7684\u7b56\u7565\uff0c\u4f8b\u5982\u5c3d\u65e9\u542f\u52a8\u5408\u89c4\u9879\u76ee\u3001\u91cd\u65b0\u8bc4\u4f30\u4ea7\u54c1\u7ec4\u5408\u3001\u6295\u8d44\u4e8e\u4e34\u5e8a\u6570\u636e\u751f\u6210\u548c\u7ba1\u7406\uff0c\u4ee5\u53ca\u4e0e\u7ecf\u9a8c\u4e30\u5bcc\u7684\u6cd5\u89c4\u4e13\u5bb6\u5408\u4f5c\uff0c\u786e\u4fdd\u80fd\u591f\u987a\u5229\u8fc7\u6e21\u5230\u65b0\u7684\u76d1\u7ba1\u65f6\u4ee3\u3002<\/p>\n<\/p>\n

\u516b\u3001\u603b\u7ed3\u4e0e\u5c55\u671b<\/strong><\/p>\n

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u7684\u5b9e\u65bd\u6807\u5fd7\u7740\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u8fdb\u5165\u4e86\u4e00\u4e2a\u65b0\u7684\u3001\u66f4\u4e25\u683c\u7684\u65f6\u4ee3\u3002<\/p>\n<\/p>\n

\u867d\u7136\u77ed\u671f\u5185\u7ed9\u884c\u4e1a\u5e26\u6765\u4e86\u9635\u75db\uff0c\u4f46\u4ece\u957f\u8fdc\u770b\uff0c\u5b83\u901a\u8fc7\u5f3a\u5316\u5168\u751f\u547d\u5468\u671f\u7684\u76d1\u7ba1\u3001\u589e\u5f3a\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\uff0c\u6700\u7ec8\u65e8\u5728\u4e3a\u60a3\u8005\u548c\u7528\u6237\u63d0\u4f9b\u66f4\u9ad8\u6c34\u5e73\u7684\u5b89\u5168\u4fdd\u969c\u3002<\/p>\n<\/p>\n

\u6df1\u5165\u4e86\u89e3\u5e76\u4e25\u683c\u9075\u5b88MDR\u7684\u6700\u65b0\u8981\u6c42\uff0c\u5df2\u6210\u4e3a\u6240\u6709\u5e0c\u671b\u8fdb\u5165\u6216\u7ef4\u6301\u5728\u6b27\u76df\u5e02\u573a\u8fd0\u8425\u7684\u4f01\u4e1a\u7684\u5fc5\u7531\u4e4b\u8def\u3002<\/p>\n<\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u6700\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76ee\u5f55\u662f\u5f53\u524d\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5173\u6ce8\u7684\u7126\u70b9\uff0c\u5b83\u4ee3\u8868\u4e86\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f53\u7cfb\u7684\u91cd\u5927\u53d8\u9769\u3002 \u8fd9\u4e00\u5168\u65b0 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[671],"class_list":["post-4347","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-671"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4347","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4347"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4347\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4347"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4347"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4347"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}