{"id":4147,"date":"2025-09-04T13:58:11","date_gmt":"2025-09-04T05:58:11","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4147"},"modified":"2025-09-04T13:58:11","modified_gmt":"2025-09-04T05:58:11","slug":"%e6%ac%a7%e7%9b%9f%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0ce%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4147","title":{"rendered":"\u6b27\u76df\u533b\u7597\u5668\u68b0ce\u8ba4\u8bc1"},"content":{"rendered":"

\u4e00\u3001\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\uff1a\u5f00\u542f\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u901a\u884c\u8bc1<\/strong><\/p>\n

\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u662f\u4ea7\u54c1\u8fdb\u5165\u6b27\u6d32\u7ecf\u6d4e\u533a\u5e02\u573a\u7684\u5f3a\u5236\u6027\u5408\u89c4\u6807\u5fd7\uff0c\u4ee3\u8868\u7740\u5236\u9020\u5546\u58f0\u660e\u5176\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u7684\u57fa\u672c\u8981\u6c42\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u4efb\u4f55\u5e0c\u671b\u5c06\u533b\u7597\u5668\u68b0\u9500\u5f80\u6b27\u76df\u5e02\u573a\u7684\u4f01\u4e1a\u800c\u8a00\uff0c\u7406\u89e3\u5e76\u6210\u529f\u83b7\u5f97CE\u8ba4\u8bc1\u662f\u81f3\u5173\u91cd\u8981\u7684\u4e00\u6b65\uff0c\u5b83\u4e0d\u4ec5\u5173\u4e4e\u5e02\u573a\u51c6\u5165\uff0c\u66f4\u662f\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u6743\u5a01\u8bc1\u660e\u3002<\/p>\n<\/p>\n

\u4e8c\u3001\u4ec0\u4e48\u662f\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\uff1f<\/strong><\/p>\n

CE\u6807\u5fd7\u662f\u4ea7\u54c1\u5728\u6b27\u76df\u5e02\u573a\u81ea\u7531\u6d41\u901a\u7684\u201c\u62a4\u7167\u201d\uff0c\u5176\u542b\u4e49\u662f\u201c\u7b26\u5408\u6b27\u6d32\u8981\u6c42\u201d\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u800c\u8a00\uff0cCE\u8ba4\u8bc1\u5e76\u975e\u7531\u67d0\u4e2a\u5355\u4e00\u673a\u6784\u9881\u53d1\uff0c\u800c\u662f\u5236\u9020\u5546\u901a\u8fc7\u4e00\u7cfb\u5217\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\uff0c\u8bc1\u660e\u5176\u4ea7\u54c1\u6ee1\u8db3\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR (EU) 2017\/745\uff09\u6216\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08IVDR (EU) 2017\/746\uff09\u4e2d\u5173\u4e8e\u5b89\u5168\u3001\u5065\u5eb7\u548c\u73af\u5883\u4fdd\u62a4\u7684\u6cd5\u5f8b\u8981\u6c42\u540e\uff0c\u81ea\u884c\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\u5e76\u52a0\u8d34CE\u6807\u5fd7\u7684\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u4e3a\u4f55CE\u8ba4\u8bc1\u5bf9\u533b\u7597\u5668\u68b0\u81f3\u5173\u91cd\u8981\uff1f<\/strong><\/p>\n

\u83b7\u5f97CE\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u76df\u3001\u6b27\u6d32\u81ea\u7531\u8d38\u6613\u8054\u76df\u4ee5\u53ca\u571f\u8033\u5176\u7b49\u5e02\u573a\u7684\u6cd5\u5b9a\u524d\u63d0\u6761\u4ef6\uff0c\u6ca1\u6709CE\u6807\u5fd7\u7684\u4ea7\u54c1\u5c06\u65e0\u6cd5\u5728\u8fd9\u4e9b\u5730\u533a\u8fdb\u884c\u5546\u4e1a\u9500\u552e\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0cCE\u8ba4\u8bc1\u63d0\u5347\u4e86\u4ea7\u54c1\u7684\u5e02\u573a\u4fe1\u8a89\u548c\u7ade\u4e89\u529b\uff0c\u5411\u533b\u751f\u3001\u60a3\u8005\u53ca\u91c7\u8d2d\u65b9\u8bc1\u660e\u4e86\u4ea7\u54c1\u5df2\u8fbe\u5230\u6b27\u76df\u4e25\u683c\u7684\u6cd5\u89c4\u6807\u51c6\uff0c\u589e\u5f3a\u4e86\u5ba2\u6237\u5bf9\u4ea7\u54c1\u7684\u4fe1\u4efb\u5ea6\uff0c\u540c\u65f6\u4e5f\u662f\u89c4\u907f\u6cd5\u5f8b\u98ce\u9669\u3001\u5c65\u884c\u4f01\u4e1a\u793e\u4f1a\u8d23\u4efb\u7684\u91cd\u8981\u4f53\u73b0\u3002<\/p>\n<\/p>\n

\u56db\u3001\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u7684\u6838\u5fc3\u6d41\u7a0b\u89e3\u6790<\/strong><\/p>\n

CE\u8ba4\u8bc1\u8fc7\u7a0b\u590d\u6742\u4e14\u4e25\u8c28\uff0c\u901a\u5e38\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u5173\u952e\u6b65\u9aa4\u3002<\/p>\n<\/p>\n

\u7b2c\u4e00\u6b65\u662f\u8fdb\u884c\u533b\u7597\u5668\u68b0\u5206\u7c7b\uff0c\u6839\u636e\u4ea7\u54c1\u7684\u9884\u671f\u7528\u9014\u3001\u4fb5\u5165\u7a0b\u5ea6\u3001\u4f7f\u7528\u6301\u7eed\u65f6\u95f4\u7b49\u56e0\u7d20\uff0c\u6309\u7167MDR\/IVDR\u9644\u5f55VIII\u7684\u89c4\u5219\u5c06\u5176\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff08\u98ce\u9669\u9010\u7ea7\u5347\u9ad8\uff09\uff0c\u5206\u7c7b\u7ed3\u679c\u76f4\u63a5\u51b3\u5b9a\u4e86\u540e\u7eed\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u7684\u4e25\u683c\u7a0b\u5ea6\u3002<\/p>\n<\/p>\n

\u7b2c\u4e8c\u6b65\u662f\u9009\u62e9\u5e76\u6307\u5b9a\u6b27\u76df\u6388\u6743\u4ee3\u8868\uff0c\u5bf9\u4e8e\u4f4d\u4e8e\u6b27\u76df\u4ee5\u5916\u7684\u5236\u9020\u5546\uff0c\u5fc5\u987b\u5728\u6b27\u76df\u5883\u5185\u6307\u5b9a\u4e00\u5bb6\u6388\u6743\u4ee3\u8868\uff0c\u8d1f\u8d23\u5728\u6b27\u76df\u5883\u5185\u4ee3\u8868\u5236\u9020\u5546\u5c65\u884c\u7279\u5b9a\u7684\u6cd5\u89c4\u4e49\u52a1\uff0c\u6210\u4e3a\u4e0e\u6b27\u76df\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u7684\u6865\u6881\u3002<\/p>\n<\/p>\n

\u7b2c\u4e09\u6b65\u662f\u5efa\u7acb\u5e76\u5b9e\u65bd\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u7b26\u5408MDR\/IVDR\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u901a\u5e38\u9700\u8981\u4f9d\u636eISO 13485\u6807\u51c6\u5efa\u7acb\u4f53\u7cfb\u6587\u4ef6\uff0c\u5e76\u786e\u4fdd\u5176\u6709\u6548\u8fd0\u884c\uff0c\u4ee5\u6301\u7eed\u4fdd\u8bc1\u4ea7\u54c1\u7684\u4e00\u81f4\u6027\u548c\u5408\u89c4\u6027\u3002<\/p>\n<\/p>\n

\u7b2c\u56db\u6b65\u662f\u51c6\u5907\u6280\u672f\u6587\u6863\uff0c\u6280\u672f\u6587\u6863\u662f\u8bc1\u660e\u4ea7\u54c1\u7b26\u5408\u57fa\u672c\u8981\u6c42\u7684\u6838\u5fc3\u8bc1\u636e\uff0c\u9700\u5305\u542b\u4ea7\u54c1\u8bf4\u660e\u3001\u8bbe\u8ba1\u56fe\u7eb8\u3001\u98ce\u9669\u5206\u6790\u3001\u9a8c\u8bc1\/\u786e\u8ba4\u62a5\u544a\u3001\u6807\u7b7e\u3001\u7b26\u5408\u6027\u58f0\u660e\u7b49\u8be6\u5c3d\u4fe1\u606f\uff0c\u8fd9\u4efd\u6587\u4ef6\u5fc5\u987b\u968f\u65f6\u51c6\u5907\u63a5\u53d7\u516c\u544a\u673a\u6784\u7684\u5ba1\u67e5\u3002<\/p>\n<\/p>\n

\u7b2c\u4e94\u6b65\u662f\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\uff0c\u5bf9\u4e8e\u9664\u5c11\u6570\u4f4e\u98ce\u9669I\u7c7b\u4ea7\u54c1\u5916\u7684\u5927\u90e8\u5206\u533b\u7597\u5668\u68b0\uff0c\u5236\u9020\u5546\u9700\u8981\u59d4\u6258\u4e00\u5bb6\u6b27\u76df\u516c\u544a\u673a\u6784\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\uff0c\u8bc4\u4f30\u53ef\u80fd\u5305\u62ec\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5ba1\u6838\u548c\u4ea7\u54c1\u6587\u4ef6\u5ba1\u67e5\u7b49\uff0c\u901a\u8fc7\u540e\u516c\u544a\u673a\u6784\u4f1a\u9881\u53d1CE\u8bc1\u4e66\u3002<\/p>\n<\/p>\n

\u7b2c\u516d\u6b65\u662f\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\u5e76\u52a0\u8d34CE\u6807\u5fd7\uff0c\u5728\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u6240\u6709\u9002\u7528\u8981\u6c42\u540e\uff0c\u5236\u9020\u5546\u9700\u7b7e\u7f72\u6b27\u76df\u7b26\u5408\u6027\u58f0\u660e\uff0c\u5e76\u5728\u4ea7\u54c1\u53ca\u5176\u5305\u88c5\u4e0a\u52a0\u8d34CE\u6807\u5fd7\uff0c\u81f3\u6b64\uff0c\u4ea7\u54c1\u65b9\u53ef\u5408\u6cd5\u6295\u653e\u6b27\u76df\u5e02\u573a\u3002<\/p>\n<\/p>\n

\u4e94\u3001MDR\u65b0\u6cd5\u89c4\u5e26\u6765\u7684\u6311\u6218\u4e0e\u53d8\u5316<\/strong><\/p>\n

2017\u5e74\u53d1\u5e03\u7684\u6b27\u76df\u533b\u7597\u5668\u68b0\u65b0\u6cd5\u89c4\u6781\u5927\u5730\u6539\u53d8\u4e86\u76d1\u7ba1\u683c\u5c40\uff0c\u5bf9\u5236\u9020\u5546\u63d0\u51fa\u4e86\u66f4\u4e25\u5cfb\u7684\u6311\u6218\u3002<\/p>\n<\/p>\n

MDR\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\uff0c\u8981\u6c42\u6240\u6709\u5668\u68b0\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u6570\u636e\u6765\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u5373\u4f7f\u5bf9\u4e8e\u4ee5\u5f80\u5df2\u83b7\u5f97\u8ba4\u8bc1\u7684\u9057\u7559\u4ea7\u54c1\u4e5f\u4e0d\u4f8b\u5916\u3002<\/p>\n<\/p>\n

\u65b0\u6cd5\u89c4\u6269\u5927\u4e86\u4ea7\u54c1\u8303\u56f4\uff0c\u5bf9\u67d0\u4e9b previously\u672a\u660e\u786e\u89c4\u5236\u7684\u4ea7\u54c1\u8fdb\u884c\u4e86\u660e\u786e\u5b9a\u4e49\u548c\u7ba1\u8f96\uff0c\u5e76\u663e\u8457\u52a0\u5f3a\u4e86\u4e0a\u5e02\u540e\u76d1\u7763\u3001\u8b66\u6212\u548c\u8ffd\u6eaf\u6027\u8981\u6c42\uff0c\u8981\u6c42\u5236\u9020\u5546\u5efa\u7acb\u66f4\u5b8c\u5584\u7684\u4f53\u7cfb\u6765\u76d1\u63a7\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u7684\u8868\u73b0\u3002<\/p>\n<\/p>\n

\u516d\u3001\u5e38\u89c1\u8bef\u533a\u4e0e\u6210\u529f\u7b56\u7565<\/strong><\/p>\n

\u5728CE\u8ba4\u8bc1\u8fc7\u7a0b\u4e2d\uff0c\u5236\u9020\u5546\u5e38\u9677\u5165\u4e00\u4e9b\u8bef\u533a\uff0c\u4f8b\u5982\u8ba4\u4e3aCE\u8ba4\u8bc1\u662f\u4e00\u52b3\u6c38\u9038\u7684\uff0c\u800c\u5b9e\u9645\u4e0a\u5b83\u662f\u4e00\u4e2a\u6301\u7eed\u7684\u8fc7\u7a0b\uff0c\u9700\u8981\u6301\u7eed\u7684\u7ef4\u62a4\u548c\u66f4\u65b0\u3002<\/p>\n<\/p>\n

\u53e6\u4e00\u4e2a\u5e38\u89c1\u8bef\u533a\u662f\u4f4e\u4f30\u4e86\u6280\u672f\u6587\u6863\u7684\u590d\u6742\u6027\u548c\u91cd\u8981\u6027\uff0c\u5c06\u5176\u89c6\u4e3a\u7b80\u5355\u7684 paperwork\uff0c\u800c\u5b9e\u9645\u4e0a\u5b83\u662f\u8ba4\u8bc1\u7684\u6838\u5fc3\uff0c\u6210\u529f\u7b56\u7565\u5728\u4e8e\u5c3d\u65e9\u89c4\u5212\uff0c\u9884\u7559\u5145\u8db3\u7684\u65f6\u95f4\u548c\u9884\u7b97\uff0c\u9009\u62e9\u7ecf\u9a8c\u4e30\u5bcc\u7684\u5408\u4f5c\u4f19\u4f34\uff0c\u5e76\u6df1\u523b\u7406\u89e3\u6cd5\u89c4\u7684\u672c\u8d28\u662f\u786e\u4fdd\u60a3\u8005\u5b89\u5168\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u83b7\u5f97\u4e00\u5f20\u5e02\u573a\u51c6\u5165\u8bc1\u4e66\u3002<\/p>\n<\/p>\n

\u4e03\u3001\u7ed3\u8bba<\/strong><\/p>\n

\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u662f\u4e00\u9879\u590d\u6742\u4f46\u5fc5\u4e0d\u53ef\u5c11\u7684\u7cfb\u7edf\u6027\u5de5\u7a0b\uff0c\u5b83\u6df1\u523b\u4f53\u73b0\u4e86\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u9ad8\u5ea6\u91cd\u89c6\u3002<\/p>\n<\/p>\n

\u9762\u5bf9\u65e5\u76ca\u4e25\u683c\u7684\u76d1\u7ba1\u73af\u5883\uff0c\u7279\u522b\u662fMDR\/IVDR\u7684\u5b9e\u65bd\uff0c\u5236\u9020\u5546\u5fc5\u987b\u91c7\u53d6\u79ef\u6781\u4e3b\u52a8\u7684\u6001\u5ea6\uff0c\u6df1\u5165\u7406\u89e3\u6cd5\u89c4\u8981\u6c42\uff0c\u7cfb\u7edf\u89c4\u5212\u8ba4\u8bc1\u8def\u5f84\uff0c\u6295\u5165\u5fc5\u8981\u7684\u8d44\u6e90\uff0c\u624d\u80fd\u6210\u529f\u8de8\u8d8a\u8fd9\u9053\u95e8\u69db\uff0c\u5728\u5168\u7403\u6700\u91cd\u8981\u7684\u533b\u7597\u5668\u68b0\u5e02\u573a\u4e4b\u4e00\u7ad9\u7a33\u811a\u8ddf\uff0c\u5b9e\u73b0\u53ef\u6301\u7eed\u7684\u5546\u4e1a\u6210\u529f\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":"

\u4e00\u3001\u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\uff1a\u5f00\u542f\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u901a\u884c\u8bc1 \u6b27\u76df\u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u662f\u4ea7\u54c1\u8fdb\u5165\u6b27\u6d32\u7ecf\u6d4e\u533a\u5e02\u573a\u7684\u5f3a\u5236\u6027\u5408\u89c4\u6807 […]<\/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":[471],"class_list":["post-4147","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-ce"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4147","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=4147"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4147\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4147"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4147"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}