{"id":22204,"date":"2026-04-30T09:18:37","date_gmt":"2026-04-30T01:18:37","guid":{"rendered":"https:\/\/miomicon.com\/%e9%9a%90%e5%bd%a2%e7%9c%bc%e9%95%9c%e8%ae%a4%e8%af%81%e4%b8%ba%e4%bd%95%e9%87%8d%e8%a6%81%ef%bc%9ace%e3%80%81fda%e5%92%8ciso-13485-%e8%af%a6%e8%a7%a3\/"},"modified":"2026-04-30T09:18:37","modified_gmt":"2026-04-30T01:18:37","slug":"%e9%9a%90%e5%bd%a2%e7%9c%bc%e9%95%9c%e8%ae%a4%e8%af%81%e4%b8%ba%e4%bd%95%e9%87%8d%e8%a6%81%ef%bc%9ace%e3%80%81fda%e5%92%8ciso-13485-%e8%af%a6%e8%a7%a3","status":"publish","type":"post","link":"https:\/\/miomicon.com\/zh-hans\/%e9%9a%90%e5%bd%a2%e7%9c%bc%e9%95%9c%e8%ae%a4%e8%af%81%e4%b8%ba%e4%bd%95%e9%87%8d%e8%a6%81%ef%bc%9ace%e3%80%81fda%e5%92%8ciso-13485-%e8%af%a6%e8%a7%a3\/","title":{"rendered":"\u9690\u5f62\u773c\u955c\u8ba4\u8bc1\u4e3a\u4f55\u91cd\u8981\uff1aCE\u3001FDA\u548cISO 13485 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predicate \u5668\u68b0\u5b9e\u8d28\u7b49\u540c<\/li>\n<li>\u673a\u6784\u6ce8\u518c\u2014\u2014\u751f\u4ea7\u8bbe\u65bd\u5fc5\u987b\u5411FDA\u6ce8\u518c<\/li>\n<li>\u5668\u68b0\u5217\u540d\u2014\u2014\u6bcf\u4e00\u6b3e\u9690\u5f62\u773c\u955c\u4ea7\u54c1\u90fd\u5fc5\u987b\u5411FDA\u5217\u540d<\/li>\n<li>\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff08QSR\uff09\u5408\u89c4\u2014\u2014\u7b49\u540c\u4e8eISO\u6807\u51c6 13485<\/li>\n<li>\u6807\u7b7e\u8981\u6c42\u2014\u2014\u5fc5\u987b\u5305\u542b\u7279\u5b9a\u7684\u8b66\u793a\u3001\u8bf4\u660e\u548c\u4ea7\u54c1\u4fe1\u606f<\/li>\n<\/ul>\n<p><strong>\u8fd9\u5bf9\u60a8\u7684\u54c1\u724c\u610f\u5473\u7740\u4ec0\u4e48\uff1a<\/strong> FDA\u5bf9\u5f69\u8272\u9690\u5f62\u773c\u955c\u8fdb\u53e3\u7684\u76d1\u7ba1\u65e5\u76ca\u4e25\u683c\u3002\u5728 2024-2025\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u9500\u552e\u672a\u5728FDA\u6ce8\u518c\u7684\u5f69\u8272\u9690\u5f62\u773c\u955c\u7684\u96f6\u552e\u5546\u91c7\u53d6\u4e86\u591a\u9879\u6267\u6cd5\u884c\u52a8\u3002\u5982\u679c\u60a8\u7784\u51c6\u7f8e\u56fd\u5e02\u573a\uff0c\u8bf7\u6838\u5b9e\u60a8\u7684\u5236\u9020\u5546\u7684\u7279\u5b9a\u4ea7\u54c1\u7ebf\u5df2\u83b7\u5f97FDA 510\uff08k\uff09\u8bb8\u53ef\u2014\u2014\u800c\u4e0d\u4ec5\u4ec5\u662f\u666e\u901a\u6ce8\u518c\u3002<\/p>\n<h2>ISO 13485 \uff08\u5168\u7403\u8d28\u91cf\u7ba1\u7406\uff09<\/h2>\n<p>ISO 13485 \u662f\u4e13\u95e8\u9488\u5bf9\u533b\u7597\u5668\u68b0\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u56fd\u9645\u6807\u51c6\u3002\u4e0e\u9488\u5bf9\u7279\u5b9a\u5e02\u573a\u7684CE\u548cFDA\u4e0d\u540c\uff0cISO 13485 \u662f\u4e00\u9879\u5168\u7403\u6807\u51c6\uff0c\u5f70\u663e\u5236\u9020\u5546\u5bf9\u54c1\u8d28\u7684\u627f\u8bfa\u3002<\/p>\n<p><strong>\u4ec0\u4e48\u662fISO 13485 \u6db5\u76d6\u5185\u5bb9\uff1a<\/strong><\/p>\n<ul>\n<li>\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u7ba1\u63a7<\/li>\n<li>\u6587\u4ef6\u4e0e\u8bb0\u5f55\u7ba1\u7406<\/li>\n<li>\u4f9b\u5e94\u5546\u8bc4\u4f30\u4e0e\u91c7\u8d2d\u7ba1\u63a7<\/li>\n<li>\u751f\u4ea7\u5de5\u827a\u9a8c\u8bc1<\/li>\n<li>\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u4f53\u7cfb<\/li>\n<li>\u5185\u90e8\u5ba1\u8ba1\u4e0e\u7ba1\u7406\u8bc4\u5ba1<\/li>\n<\/ul>\n<p><strong>\u8fd9\u5bf9\u60a8\u7684\u54c1\u724c\u610f\u5473\u7740\uff1a<\/strong> ISO 13485 \u5927\u591a\u6570\u5e02\u573a\u5e76\u672a\u5728\u6cd5\u5f8b\u5c42\u9762\u5f3a\u5236\u8981\u6c42\u8be5\u8ba4\u8bc1\uff0c\u4f46\u5b83\u662f\u5236\u9020\u8d28\u91cf\u7684\u6709\u529b\u8bc1\u660e\u3002\u62e5\u6709ISO\u8ba4\u8bc1\u7684\u5236\u9020\u5546\u5df2\u8bc1\u660e\u5176\u5177\u5907\u7a33\u5b9a\u7684\u8d28\u91cf\u7ba1\u7406\u5b9e\u8df5\uff0c\u8fd9\u610f\u5473\u7740\u4ea7\u54c1\u66f4\u53ef\u9760\uff0c\u8d28\u91cf\u95ee\u9898\u66f4\u5c11\u3002 13485 \u8ba4\u8bc1\u5df2\u8bc1\u660e\u5176\u5177\u5907\u7a33\u5b9a\u7684\u8d28\u91cf\u7ba1\u7406\u5b9e\u8df5\uff0c\u8fd9\u610f\u5473\u7740\u4ea7\u54c1\u66f4\u53ef\u9760\uff0c\u8d28\u91cf\u95ee\u9898\u66f4\u5c11\u3002<\/p>\n<h2>\u5176\u4ed6\u533a\u57df\u8ba4\u8bc1<\/h2>\n<p><strong>\u97e9\u56fd\uff08KFDA\uff09\uff1a<\/strong> \u5728\u97e9\u56fd\u5e02\u573a\u9500\u552e\u7684\u5fc5\u5907\u6761\u4ef6\u3002\u97e9\u56fd\u662f\u5168\u7403\u5f69\u8272\u9690\u5f62\u773c\u955c\u6e17\u900f\u7387\u6700\u9ad8\u7684\u5730\u533a\u4e4b\u4e00\uff0cKFDA\u8ba4\u8bc1\u4e3a\u5f3a\u5236\u8981\u6c42\u3002<\/p>\n<p><strong>\u52a0\u62ff\u5927\uff08\u52a0\u62ff\u5927\u536b\u751f\u90e8\uff09\uff1a<\/strong> \u9690\u5f62\u773c\u955c\u9700\u53d6\u5f97\u533b\u7597\u5668\u68b0\u8bb8\u53ef\u8bc1\uff08MDL\uff09\u3002\u52a0\u62ff\u5927\u91c7\u7528\u4e0eFDA\u7c7b\u4f3c\u7684\u98ce\u9669\u5206\u7ea7\u4f53\u7cfb\u3002<\/p>\n<p><strong>\u6fb3\u5927\u5229\u4e9a\uff08TGA\uff09\uff1a<\/strong> \u6839\u636e\u6fb3\u5927\u5229\u4e9a\u533b\u7597\u7528\u54c1\u7ba1\u7406\u5c40\u7684\u89c4\u5b9a\uff0c\u9690\u5f62\u773c\u955c\u5c5e\u4e8eIII\u7c7b\u533b\u7597\u5668\u68b0\u3002\u9700\u7eb3\u5165\u6fb3\u5927\u5229\u4e9a\u533b\u7597\u7528\u54c1\u767b\u8bb0\u518c\uff08ARTG\uff09\u3002<\/p>\n<p><strong>\u4e2d\u4e1c\uff08\u6d77\u6e7e\u5408\u4f5c\u59d4\u5458\u4f1aGCC\uff09\uff1a<\/strong> \u6bcf\u4e00\u4e2a\u6d77\u6e7e\u963f\u62c9\u4f2f\u56fd\u5bb6\u5408\u4f5c\u59d4\u5458\u4f1a\u6210\u5458\u56fd\u90fd\u8bbe\u6709\u5404\u81ea\u7684\u76d1\u7ba1\u673a\u6784\uff08\u6c99\u7279\u963f\u62c9\u4f2f\u4e3a\u6c99\u7279\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40SFDA\uff0c\u963f\u8054\u914b\u4e3a\u963f\u8054\u914b\u536b\u751f\u548c\u9884\u9632\u90e8MOHAP\uff09\uff0c\u4f46\u6240\u6709\u6210\u5458\u56fd\u5747\u8ba4\u53efCE\u548cFDA\u8ba4\u8bc1\u4f5c\u4e3a\u6ce8\u518c\u6d41\u7a0b\u7684\u4e00\u90e8\u5206\u3002<\/p>\n<h2>\u5982\u4f55\u9a8c\u8bc1\u5236\u9020\u5546\u8d44\u8d28<\/h2>\n<p>\u8bc4\u4f30\u9690\u5f62\u773c\u955c\u5236\u9020\u5546\u65f6\uff0c\u8bf7\u9075\u5faa\u4ee5\u4e0b\u6b65\u9aa4\uff1a<\/p>\n<p><strong>1. \u76f4\u63a5\u7d22\u8981\u8bc1\u4e66\u3002<\/strong> \u7d22\u8981CE\u8bc1\u4e66\u526f\u672c\u3001FDA\u6ce8\u518c\u6587\u4ef6\u4ee5\u53caISO 13485 \u8bc1\u4e66\u3002\u6b63\u89c4\u7684\u5236\u9020\u5546\u4f1a\u6beb\u4e0d\u72b9\u8c6b\u5730\u63d0\u4f9b\u8fd9\u4e9b\u6587\u4ef6\u3002<\/p>\n<p><strong>2. \u9a8c\u8bc1\u8bc1\u4e66\u7f16\u53f7\u3002<\/strong> CE\u8bc1\u4e66\u53ef\u901a\u8fc7\u516c\u544a\u673a\u6784\u8fdb\u884c\u9a8c\u8bc1\u3002FDA\u6ce8\u518c\u53ef\u901a\u8fc7FDA\u7684\u673a\u6784\u6ce8\u518c\u6570\u636e\u5e93\u8fdb\u884c\u6838\u67e5\u3002<\/p>\n<p><strong>3. \u6838\u67e5\u8ba4\u8bc1\u8303\u56f4\u3002<\/strong> \u786e\u4fdd\u8bc1\u4e66\u660e\u786e\u8986\u76d6\u5f69\u8272\u9690\u5f62\u773c\u955c\uff0c\u800c\u975e\u4ec5\u8986\u76d6\u666e\u901a\u900f\u660e\u955c\u7247\u6216\u5176\u4ed6\u533b\u7597\u5668\u68b0\u3002<\/p>\n<p><strong>4. \u8be2\u95ee\u7eed\u671f\u65e5\u671f\u3002<\/strong> 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