{"id":4059,"date":"2025-09-04T13:58:05","date_gmt":"2025-09-04T05:58:05","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4059"},"modified":"2025-09-04T13:58:05","modified_gmt":"2025-09-04T05:58:05","slug":"mdr%e8%ae%a4%e8%af%81%e9%9c%80%e8%a6%81%e5%93%aa%e4%ba%9b%e8%b5%84%e6%96%99","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4059","title":{"rendered":"mdr\u8ba4\u8bc1\u9700\u8981\u54ea\u4e9b\u8d44\u6599"},"content":{"rendered":"

MDR\u8ba4\u8bc1\u9700\u8981\u54ea\u4e9b\u8d44\u6599\u662f\u4f17\u591a\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5728\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u65f6\u5fc5\u987b\u9762\u5bf9\u7684\u6838\u5fc3\u95ee\u9898\uff0c\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u7684\u5168\u9762\u5b9e\u65bd\uff0c\u7533\u8bf7\u6d41\u7a0b\u7684\u590d\u6742\u6027\u548c\u8d44\u6599\u8981\u6c42\u7684\u4e25\u683c\u6027\u663e\u8457\u63d0\u5347\uff0c\u4f01\u4e1a\u9700\u7cfb\u7edf\u51c6\u5907\u5e76\u63d0\u4ea4\u4e00\u7cfb\u5217\u5173\u952e\u6587\u4ef6\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u5e76\u987a\u5229\u901a\u8fc7\u5ba1\u6838\u3002<\/p>\n<\/p>\n

\u4e00\u3001MDR\u8ba4\u8bc1\u6982\u8ff0\u53ca\u6838\u5fc3\u8d44\u6599\u6e05\u5355<\/strong><\/p>\n

MDR\u8ba4\u8bc1\u662f\u6b27\u76df\u9488\u5bf9\u533b\u7597\u5668\u68b0\u5e02\u573a\u51c6\u5165\u7684\u5f3a\u5236\u6027\u6cd5\u89c4\u6846\u67b6\uff0c\u5176\u6838\u5fc3\u5728\u4e8e\u901a\u8fc7\u5168\u9762\u6280\u672f\u6587\u6863\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8bc1\u660e\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u3001\u6027\u80fd\u53ca\u5408\u89c4\u6027\uff0c\u4f01\u4e1a\u9700\u8981\u51c6\u5907\u7684\u57fa\u7840\u8d44\u6599\u5305\u62ec\u6280\u672f\u6587\u6863\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6587\u4ef6\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\u4ee5\u53ca\u7b26\u5408\u6027\u58f0\u660e\u7b49\uff0c\u8fd9\u4e9b\u6587\u4ef6\u5171\u540c\u6784\u6210\u8ba4\u8bc1\u7533\u8bf7\u7684\u57fa\u7840\uff0c\u7f3a\u5931\u4efb\u4f55\u90e8\u5206\u90fd\u53ef\u80fd\u5bfc\u81f4\u5ba1\u6838\u5ef6\u8fdf\u6216\u5931\u8d25\u3002<\/p>\n<\/p>\n

\u4e8c\u3001\u6280\u672f\u6587\u6863\u7684\u8be6\u7ec6\u7ec4\u6210<\/strong><\/p>\n

\u6280\u672f\u6587\u6863\u662fMDR\u8ba4\u8bc1\u4e2d\u6700\u6838\u5fc3\u7684\u90e8\u5206\uff0c\u5b83\u5fc5\u987b\u5305\u542b\u4ea7\u54c1\u63cf\u8ff0\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u5236\u9020\u8fc7\u7a0b\u3001\u6027\u80fd\u6570\u636e\u53ca\u98ce\u9669\u8bc4\u4f30\u7b49\u5185\u5bb9\uff0c\u5177\u4f53\u9700\u63d0\u4f9b\u4ea7\u54c1\u6807\u8bc6\u548c\u89c4\u683c\u8bf4\u660e\uff0c\u5982\u578b\u53f7\u3001\u540d\u79f0\u548c\u9884\u671f\u7528\u9014\uff1b\u8bbe\u8ba1\u56fe\u7eb8\u548c\u8f6f\u4ef6\u89c4\u8303\uff1b\u539f\u6750\u6599\u548c\u7ec4\u4ef6\u4f9b\u5e94\u5546\u4fe1\u606f\uff1b\u751f\u4ea7\u5de5\u827a\u6d41\u7a0b\u56fe\u548c\u8d28\u91cf\u63a7\u5236\u70b9\uff1b\u4ea7\u54c1\u6d4b\u8bd5\u62a5\u544a\uff08\u5305\u62ec\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7535\u6c14\u5b89\u5168\u7b49\uff09\uff1b\u4ee5\u53ca\u8be6\u7ec6\u7684\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\uff08\u57fa\u4e8eISO 14971\u6807\u51c6\uff09\uff0c\u6b64\u5916\uff0c\u6807\u7b7e\u548c\u8bf4\u660e\u4e66\u4e5f\u5fc5\u987b\u7b26\u5408MDR\u8bed\u8a00\u548c\u5185\u5bb9\u8981\u6c42\uff0c\u786e\u4fdd\u7528\u6237\u80fd\u5b89\u5168\u4f7f\u7528\u4ea7\u54c1\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6587\u4ef6\u8981\u6c42<\/strong><\/p>\n

MDR\u5f3a\u8c03\u5168\u751f\u547d\u5468\u671f\u7684\u8d28\u91cf\u7ba1\u7406\uff0c\u56e0\u6b64\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5e76\u7ef4\u62a4\u7b26\u5408ISO 13485\u6807\u51c6\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u6240\u9700\u8d44\u6599\u5305\u62ec\u8d28\u91cf\u624b\u518c\u3001\u7a0b\u5e8f\u6587\u4ef6\u3001\u8bb0\u5f55\u8868\u683c\u7b49\uff0c\u4f8b\u5982\u7ba1\u7406\u8bc4\u5ba1\u62a5\u544a\u3001\u5185\u90e8\u5ba1\u6838\u8bb0\u5f55\u3001 corrective and preventive actions\uff08CAPA\uff09\u6587\u4ef6\u3001\u4f9b\u5e94\u5546\u8bc4\u4f30\u8bb0\u5f55\u4ee5\u53ca\u751f\u4ea7\u8fc7\u7a0b\u63a7\u5236\u6587\u6863\uff0c\u8fd9\u4e9b\u6587\u4ef6\u8bc1\u660e\u4f01\u4e1a\u80fd\u6301\u7eed\u76d1\u63a7\u4ea7\u54c1\u5b89\u5168\uff0c\u5e76\u53ca\u65f6\u5904\u7406\u6f5c\u5728\u95ee\u9898\uff0c\u8ba4\u8bc1\u673a\u6784\u901a\u5e38\u4f1a\u8fdb\u884c\u73b0\u573a\u5ba1\u6838\u4ee5\u9a8c\u8bc1\u4f53\u7cfb\u8fd0\u884c\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n

\u56db\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u548c\u4e34\u5e8a\u8bc1\u636e<\/strong><\/p>\n

\u4e34\u5e8a\u8bc4\u4ef7\u662fMDR\u8ba4\u8bc1\u7684\u5173\u952e\u73af\u8282\uff0c\u8981\u6c42\u4f01\u4e1a\u63d0\u4f9b\u5145\u5206\u7684\u4e34\u5e8a\u8bc1\u636e\u8bc1\u660e\u4ea7\u54c1\u5b89\u5168\u548c\u6027\u80fd\uff0c\u8d44\u6599\u9700\u5305\u62ec\u4e34\u5e8a\u8bc4\u4ef7\u8ba1\u5212\uff08CEP\uff09\u3001\u4e34\u5e8a\u6587\u732e\u7efc\u8ff0\u3001\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a\u6570\u636e\uff08PMCF\uff09\u4ee5\u53ca\u5fc5\u8981\u65f6\u7684\u65b0\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\uff0c\u5bf9\u4e8e\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u5982\u690d\u5165\u5f0f\u5668\u68b0\uff0c\u8fd8\u9700\u63d0\u4ea4\u66f4\u8be6\u7ec6\u7684\u4e34\u5e8a\u8c03\u67e5\u65b9\u6848\u548c\u7ed3\u679c\uff0c\u62a5\u544a\u5fc5\u987b\u57fa\u4e8e\u6700\u65b0\u79d1\u5b66\u8bc1\u636e\uff0c\u5e76\u5b9a\u671f\u66f4\u65b0\u4ee5\u53cd\u6620\u771f\u5b9e\u4e16\u754c\u6570\u636e\uff0c\u786e\u4fdd\u5728\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\u4fdd\u6301\u5408\u89c4\u3002<\/p>\n<\/p>\n

\u4e94\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u548c vigilance \u7cfb\u7edf\u6587\u4ef6<\/strong><\/p>\n

MDR\u8981\u6c42\u4f01\u4e1a\u5efa\u7acb\u5168\u9762\u7684\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u7cfb\u7edf\uff0c\u4ee5\u76d1\u63a7\u4ea7\u54c1\u4e0a\u5e02\u540e\u7684\u5b89\u5168\u548c\u6027\u80fd\uff0c\u6240\u9700\u8d44\u6599\u5305\u62ecPMS\u8ba1\u5212\u3001\u4e0a\u5e02\u540e\u6027\u80fd\u8ddf\u8e2a\u62a5\u544a\uff08PMPR\uff09\u3001\u4e8b\u6545\u62a5\u544a\u8bb0\u5f55\u4ee5\u53ca\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\uff0c\u8fd9\u4e9b\u6587\u4ef6\u9700\u8be6\u7ec6\u63cf\u8ff0\u5982\u4f55\u6536\u96c6\u548c\u5206\u6790\u7528\u6237\u53cd\u9988\u3001\u5904\u7406\u6295\u8bc9\u4e8b\u4ef6\uff0c\u5e76\u91c7\u53d6\u6539\u8fdb\u63aa\u65bd\uff0c vigilance \u7cfb\u7edf\u8fd8\u9700\u786e\u4fdd\u53ca\u65f6\u5411\u4e3b\u7ba1\u673a\u6784\u62a5\u544a\u4e25\u91cd\u4e8b\u4ef6\uff0c\u4ece\u800c\u964d\u4f4e\u5e02\u573a\u98ce\u9669\u3002<\/p>\n<\/p>\n

\u516d\u3001\u7b26\u5408\u6027\u58f0\u660e\u548c\u6388\u6743\u4ee3\u8868\u6587\u4ef6<\/strong><\/p>\n

\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09\u662f\u5236\u9020\u5546\u6b63\u5f0f\u786e\u8ba4\u4ea7\u54c1\u7b26\u5408MDR\u8981\u6c42\u7684\u6cd5\u5f8b\u6587\u4ef6\uff0c\u9700\u5305\u542b\u4ea7\u54c1\u4fe1\u606f\u3001\u9002\u7528\u6807\u51c6\u5217\u8868\u4ee5\u53ca\u5236\u9020\u5546\u548c\u6388\u6743\u4ee3\u8868\u8be6\u60c5\uff0c\u5bf9\u4e8e\u975e\u6b27\u76df\u4f01\u4e1a\uff0c\u5fc5\u987b\u6307\u5b9a\u4e00\u540d\u6b27\u6d32\u6388\u6743\u4ee3\u8868\uff08EC Rep\uff09\uff0c\u5e76\u63d0\u4f9b\u5176\u6388\u6743\u534f\u8bae\u548c\u8054\u7cfb\u4fe1\u606f\uff0c\u8fd9\u4e9b\u8d44\u6599\u662f\u5e02\u573a\u51c6\u5165\u7684\u6700\u7ec8\u6b65\u9aa4\uff0c\u786e\u4fdd\u8d23\u4efb\u660e\u786e\u548c\u8ffd\u6eaf\u6027\u3002<\/p>\n<\/p>\n

\u4e03\u3001\u5176\u4ed6\u8f85\u52a9\u8d44\u6599\u548c\u6ce8\u610f\u4e8b\u9879<\/strong><\/p>\n

\u9664\u4e86\u4e0a\u8ff0\u6838\u5fc3\u6587\u4ef6\uff0c\u4f01\u4e1a\u8fd8\u9700\u51c6\u5907UDI\uff08\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\uff09\u6ce8\u518c\u4fe1\u606f\u3001\u4f9b\u5e94\u94fe\u5408\u89c4\u8bc1\u660e\uff08\u5982\u4f9b\u5e94\u5546\u5ba1\u8ba1\u62a5\u544a\uff09\u3001\u4ee5\u53ca\u4eba\u5458\u8d44\u8d28\u8bb0\u5f55\uff08\u5982\u8d1f\u8d23\u5408\u89c4\u4eba\u5458\u7684\u57f9\u8bad\u8bc1\u4e66\uff09\uff0c\u6ce8\u610f\u4e8b\u9879\u5305\u62ec\uff1a\u6240\u6709\u6587\u4ef6\u5fc5\u987b\u4f7f\u7528\u6b27\u76df\u5b98\u65b9\u8bed\u8a00\uff08\u5982\u82f1\u8bed\uff09\u3001\u4fdd\u6301\u7248\u672c\u66f4\u65b0\u4ee5\u53cd\u6620\u6cd5\u89c4\u53d8\u5316\uff0c\u5e76\u63d0\u524d\u4e0e\u8ba4\u8bc1\u673a\u6784\uff08\u5982T\u00dcV\u3001BSI\uff09\u6c9f\u901a\u4ee5\u907f\u514d\u5e38\u89c1\u9519\u8bef\uff0c\u6574\u4e2a\u51c6\u5907\u8fc7\u7a0b\u53ef\u80fd\u8017\u65f6\u6570\u6708\uff0c\u5efa\u8bae\u4f01\u4e1a\u5c3d\u65e9\u542f\u52a8\u4ee5\u907f\u514d\u5e02\u573a\u5ef6\u8fdf\u3002<\/p>\n<\/p>\n

\u516b\u3001\u603b\u7ed3\u4e0e\u5efa\u8bae<\/strong><\/p>\n

\u603b\u4e4b\uff0cMDR\u8ba4\u8bc1\u9700\u8981\u54ea\u4e9b\u8d44\u6599\u6d89\u53ca\u591a\u7ef4\u5ea6\u6587\u6863\uff0c\u4ece\u6280\u672f\u7ec6\u8282\u5230\u7ba1\u7406\u4f53\u7cfb\uff0c\u5747\u9700 meticulously \u51c6\u5907\u4ee5\u786e\u4fdd\u5408\u89c4\uff0c\u4f01\u4e1a\u5e94\u5236\u5b9a\u8be6\u7ec6\u8ba1\u5212\uff0c\u5229\u7528\u4e13\u4e1a\u5de5\u5177\u6216\u54a8\u8be2\u670d\u52a1\u673a\u6784\u4f18\u5316\u6d41\u7a0b\uff0c\u540c\u65f6\u5173\u6ce8MDR\u66f4\u65b0\u52a8\u6001\uff0c\u4ee5\u964d\u4f4e\u8ba4\u8bc1\u98ce\u9669\u5e76\u63d0\u5347\u5e02\u573a\u7ade\u4e89\u529b\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":"

MDR\u8ba4\u8bc1\u9700\u8981\u54ea\u4e9b\u8d44\u6599\u662f\u4f17\u591a\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5728\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u65f6\u5fc5\u987b\u9762\u5bf9\u7684\u6838\u5fc3\u95ee\u9898\uff0c\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u7684 […]<\/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":[383],"class_list":["post-4059","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4059","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=4059"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4059\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}