{"id":10719,"date":"2025-01-17T11:28:19","date_gmt":"2025-01-17T03:28:19","guid":{"rendered":"https:\/\/www.jietaisonic.com\/?p=10719"},"modified":"2025-01-17T11:28:20","modified_gmt":"2025-01-17T03:28:20","slug":"yycsbqxjdzzyqyrzfx","status":"publish","type":"post","link":"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html","title":{"rendered":"\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8981\u6c42\u4e0e\u8ba4\u8bc1\u5206\u6790"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_64 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\">\u5185\u5bb9\u76ee\u5f55<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-67d476af31d94\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #1e73be;color:#1e73be\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #1e73be;color:#1e73be\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-67d476af31d94\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#1_%E5%BC%95%E8%A8%80\" title=\"1. \u5f15\u8a00\">1. \u5f15\u8a00<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#2_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E7%9B%91%E7%AE%A1%E8%83%8C%E6%99%AF\" title=\"2. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u76d1\u7ba1\u80cc\u666f\">2. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u76d1\u7ba1\u80cc\u666f<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#21_%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%9A%84%E7%9B%91%E7%AE%A1%E6%B3%95%E8%A7%84\" title=\"2.1 \u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6cd5\u89c4\">2.1 \u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6cd5\u89c4<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#22_%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E4%BD%93%E7%B3%BB\" title=\"2.2 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\">2.2 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#3_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E8%B5%84%E8%B4%A8%E8%AE%A4%E8%AF%81%E8%A6%81%E6%B1%82\" title=\"3. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8ba4\u8bc1\u8981\u6c42\">3. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8ba4\u8bc1\u8981\u6c42<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#31_%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E5%B1%80%EF%BC%88NMPA%EF%BC%89%E8%AE%A4%E8%AF%81%EF%BC%88%E4%B8%AD%E5%9B%BD%EF%BC%89\" title=\"3.1 \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u8ba4\u8bc1\uff08\u4e2d\u56fd\uff09\">3.1 \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u8ba4\u8bc1\uff08\u4e2d\u56fd\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#32_CE%E8%AE%A4%E8%AF%81%EF%BC%88%E6%AC%A7%E7%9B%9F%EF%BC%89\" title=\"3.2 CE\u8ba4\u8bc1\uff08\u6b27\u76df\uff09\">3.2 CE\u8ba4\u8bc1\uff08\u6b27\u76df\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#33_FDA%E8%AE%A4%E8%AF%81%EF%BC%88%E7%BE%8E%E5%9B%BD%EF%BC%89\" title=\"3.3 FDA\u8ba4\u8bc1\uff08\u7f8e\u56fd\uff09\">3.3 FDA\u8ba4\u8bc1\uff08\u7f8e\u56fd\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#34_ISO_13485%E8%AE%A4%E8%AF%81\" title=\"3.4 ISO 13485\u8ba4\u8bc1\">3.4 ISO 13485\u8ba4\u8bc1<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#35_RoHS%E4%B8%8EWEEE%E8%AE%A4%E8%AF%81\" title=\"3.5 RoHS\u4e0eWEEE\u8ba4\u8bc1\">3.5 RoHS\u4e0eWEEE\u8ba4\u8bc1<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#4_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E6%80%A7%E8%83%BD%E6%A0%87%E5%87%86%E4%B8%8E%E5%AE%89%E5%85%A8%E8%A6%81%E6%B1%82\" title=\"4. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u6027\u80fd\u6807\u51c6\u4e0e\u5b89\u5168\u8981\u6c42\">4. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u6027\u80fd\u6807\u51c6\u4e0e\u5b89\u5168\u8981\u6c42<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.jietaisonic.com\/xinwenzixun\/10719.html\/#5_%E7%BB%93%E8%AE%BA\" title=\"5. \u7ed3\u8bba\">5. \u7ed3\u8bba<\/a><\/li><\/ul><\/nav><\/div>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_%E5%BC%95%E8%A8%80\"><\/span>1. \u5f15\u8a00<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u968f\u7740\u533b\u7597\u6280\u672f\u7684\u4e0d\u65ad\u8fdb\u6b65\u548c\u533b\u7597\u5668\u68b0\u7684\u65e5\u76ca\u590d\u6742\u5316\uff0c\u533b\u7597\u673a\u6784\u5bf9\u8bbe\u5907\u6e05\u6d01\u548c\u6d88\u6bd2\u7684\u8981\u6c42\u8d8a\u6765\u8d8a\u9ad8\u3002\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\uff0c\u4f5c\u4e3a\u4e00\u79cd\u9ad8\u6548\u3001\u7cbe\u7ec6\u7684\u6e05\u6d17\u5de5\u5177\uff0c\u5728\u6e05\u6d17\u533b\u7597\u5668\u68b0\u3001\u624b\u672f\u5668\u68b0\u3001\u5185\u7aa5\u955c\u7b49\u65b9\u9762\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u3002\u7136\u800c\uff0c\u4e3a\u4e86\u4fdd\u8bc1\u8bbe\u5907\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u4ee5\u53ca\u64cd\u4f5c\u7684\u5408\u89c4\u6027\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u9700\u8981\u6ee1\u8db3\u4e00\u7cfb\u5217\u7684\u8d44\u8d28\u8981\u6c42\u548c\u8ba4\u8bc1\u3002\u672c\u6587\u5c06\u4ece\u884c\u4e1a\u80cc\u666f\u51fa\u53d1\uff0c\u8be6\u7ec6\u89e3\u6790\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u6240\u9700\u7684\u8d44\u8d28\u548c\u8ba4\u8bc1\u8981\u6c42\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E7%9B%91%E7%AE%A1%E8%83%8C%E6%99%AF\"><\/span>2. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u76d1\u7ba1\u80cc\u666f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u8bbe\u5907\u7684\u4e00\u90e8\u5206\uff0c\u53d7\u5230\u56fd\u5bb6\u53ca\u56fd\u9645\u5404\u7c7b\u76d1\u7ba1\u673a\u6784\u7684\u4e25\u683c\u5ba1\u67e5\u3002\u5b83\u4e0d\u4ec5\u6d89\u53ca\u5230\u6e05\u6d17\u6548\u679c\u7684\u5408\u89c4\u6027\u95ee\u9898\uff0c\u8fd8\u5173\u4e4e\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u4e0e\u6d88\u6bd2\u8d28\u91cf\u3002\u56e0\u6b64\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u5fc5\u987b\u7b26\u5408\u76f8\u5173\u6cd5\u5f8b\u6cd5\u89c4\u548c\u6280\u672f\u6807\u51c6\uff0c\u83b7\u5f97\u76f8\u5e94\u7684\u8d44\u8d28\u8ba4\u8bc1\uff0c\u624d\u80fd\u6295\u5165\u5e02\u573a\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"21_%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%9A%84%E7%9B%91%E7%AE%A1%E6%B3%95%E8%A7%84\"><\/span>2.1 \u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6cd5\u89c4<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8981\u6c42\u6709\u6240\u4e0d\u540c\u3002\u4ee5\u4e2d\u56fd\u4e3a\u4f8b\uff0c\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff0c\u6240\u6709\u6d89\u53ca\u533b\u7597\u5668\u68b0\u7684\u751f\u4ea7\u3001\u9500\u552e\u3001\u4f7f\u7528\u548c\u7ef4\u4fee\u6d3b\u52a8\u90fd\u9700\u8981\u83b7\u5f97\u76f8\u5e94\u7684\u8bb8\u53ef\u8bc1\u548c\u8ba4\u8bc1\u3002\u5728\u6b27\u76df\u5730\u533a\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u5219\u9700\u8981\u7b26\u5408\u300a\u533b\u7597\u5668\u68b0\u6307\u4ee4\u300b\uff08MDD\uff09\u6216\u300a\u533b\u7597\u5668\u68b0\u6761\u4f8b\u300b\uff08MDR\uff09\u7684\u8981\u6c42\uff0c\u5e76\u83b7\u5f97CE\u8ba4\u8bc1\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"22_%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E4%BD%93%E7%B3%BB\"><\/span>2.2 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u751f\u4ea7\u548c\u9500\u552e\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u65f6\uff0c\u4f01\u4e1a\u8fd8\u5fc5\u987b\u9075\u5b88\u56fd\u9645\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u5982ISO 13485\u3002\u8fd9\u4e00\u6807\u51c6\u4e13\u95e8\u9488\u5bf9\u533b\u7597\u5668\u68b0\u7684\u8bbe\u8ba1\u3001\u751f\u4ea7\u3001\u5b89\u88c5\u548c\u670d\u52a1\u8fc7\u7a0b\uff0c\u786e\u4fdd\u8bbe\u5907\u80fd\u591f\u6301\u7eed\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\uff0c\u5e76\u5177\u5907\u9ad8\u8d28\u91cf\u7684\u6e05\u6d17\u6548\u679c\u548c\u4f7f\u7528\u5b89\u5168\u6027\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E8%B5%84%E8%B4%A8%E8%AE%A4%E8%AF%81%E8%A6%81%E6%B1%82\"><\/span>3. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8ba4\u8bc1\u8981\u6c42<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"31_%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E5%B1%80%EF%BC%88NMPA%EF%BC%89%E8%AE%A4%E8%AF%81%EF%BC%88%E4%B8%AD%E5%9B%BD%EF%BC%89\"><\/span>3.1 \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u8ba4\u8bc1\uff08\u4e2d\u56fd\uff09<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u4e2d\u56fd\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u7684\u4e00\u79cd\uff0c\u9700\u8981\u901a\u8fc7\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684\u6ce8\u518c\u548c\u8ba4\u8bc1\u3002NMPA\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u8981\u6c42\u975e\u5e38\u4e25\u683c\uff0c\u6240\u6709\u5728\u4e2d\u56fd\u9500\u552e\u7684\u533b\u7528\u8bbe\u5907\u5fc5\u987b\u5148\u7ecf\u8fc7\u6ce8\u518c\uff0c\u4f01\u4e1a\u9700\u8981\u63d0\u4f9b\u76f8\u5173\u7684\u6280\u672f\u8d44\u6599\u548c\u4e34\u5e8a\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u4ea7\u54c1\u5728\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\u7b26\u5408\u6807\u51c6\u3002<\/p>\n\n\n\n<p>\u5728\u6ce8\u518c\u8fc7\u7a0b\u4e2d\uff0c\u4f01\u4e1a\u9700\u8981\u63d0\u4ea4\u4ee5\u4e0b\u8d44\u6599\uff1a<\/p>\n\n\n\n<ul>\n<li>\u4ea7\u54c1\u8bf4\u660e\u4e66\u3001\u6280\u672f\u6807\u51c6\u548c\u8bbe\u8ba1\u8d44\u6599\uff1b<\/li>\n\n\n\n<li>\u5b89\u5168\u6027\u548c\u6027\u80fd\u7684\u9a8c\u8bc1\u62a5\u544a\uff1b<\/li>\n\n\n\n<li>\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff08\u82e5\u9002\u7528\uff09\uff1b<\/li>\n\n\n\n<li>\u751f\u4ea7\u5382\u623f\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u5ba1\u67e5\u6587\u4ef6\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u6b64\u5916\uff0c\u6ce8\u518c\u901a\u8fc7\u540e\uff0cNMPA\u8fd8\u4f1a\u5b9a\u671f\u8fdb\u884c\u62bd\u67e5\u548c\u68c0\u67e5\uff0c\u786e\u4fdd\u4ea7\u54c1\u5728\u5e02\u573a\u4e0a\u7684\u5b89\u5168\u8fd0\u884c\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"32_CE%E8%AE%A4%E8%AF%81%EF%BC%88%E6%AC%A7%E7%9B%9F%EF%BC%89\"><\/span>3.2 CE\u8ba4\u8bc1\uff08\u6b27\u76df\uff09<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u6b27\u76df\u5e02\u573a\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u5fc5\u987b\u83b7\u5f97CE\u8ba4\u8bc1\u624d\u80fd\u4e0a\u5e02\u9500\u552e\u3002CE\u8ba4\u8bc1\u662f\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u7684\u4e00\u79cd\u5f3a\u5236\u6027\u5e02\u573a\u51c6\u5165\u6807\u5fd7\uff0c\u8868\u660e\u8be5\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u5173\u4e8e\u5b89\u5168\u3001\u5065\u5eb7\u3001\u73af\u4fdd\u7b49\u65b9\u9762\u7684\u76f8\u5173\u8981\u6c42\u3002\u4e3a\u4e86\u83b7\u5f97CE\u8ba4\u8bc1\uff0c\u751f\u4ea7\u5546\u9700\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u6761\u4f8b\u300b\uff08MDR\uff09\u8fdb\u884c\u6ce8\u518c\uff0c\u5e76\u63d0\u4f9b\u76f8\u5173\u7684\u6280\u672f\u6587\u4ef6\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul>\n<li>\u98ce\u9669\u7ba1\u7406\u62a5\u544a\uff1b<\/li>\n\n\n\n<li>\u8bbe\u5907\u8bbe\u8ba1\u4e0e\u5236\u9020\u8fc7\u7a0b\u7684\u6280\u672f\u6587\u6863\uff1b<\/li>\n\n\n\n<li>\u6027\u80fd\u6d4b\u8bd5\u4e0e\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff1b<\/li>\n\n\n\n<li>\u5408\u89c4\u58f0\u660e\u53ca\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u901a\u8fc7CE\u8ba4\u8bc1\u540e\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u624d\u80fd\u5728\u6b27\u76df\u5e02\u573a\u4e0a\u81ea\u7531\u6d41\u901a\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"33_FDA%E8%AE%A4%E8%AF%81%EF%BC%88%E7%BE%8E%E5%9B%BD%EF%BC%89\"><\/span>3.3 FDA\u8ba4\u8bc1\uff08\u7f8e\u56fd\uff09<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u7f8e\u56fd\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u9700\u8981\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u8ba4\u8bc1\u624d\u80fd\u9500\u552e\u3002FDA\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6709\u7740\u6781\u4e3a\u4e25\u683c\u7684\u8981\u6c42\u3002\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u4f5c\u4e3a\u4e00\u79cd\u533b\u7597\u8bbe\u5907\uff0c\u901a\u5e38\u9700\u8981\u901a\u8fc7FDA\u7684510(k)\u9884\u5e02\u573a\u901a\u77e5\u7a0b\u5e8f\uff0c\u5373\u8bc1\u660e\u8be5\u8bbe\u5907\u4e0e\u5e02\u573a\u4e0a\u5df2\u6709\u7684\u7c7b\u4f3c\u8bbe\u5907\u7b49\u6548\uff0c\u5e76\u7b26\u5408FDA\u7684\u5b89\u5168\u6807\u51c6\u3002\u63d0\u4ea4\u7684\u6587\u4ef6\u901a\u5e38\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul>\n<li>\u4ea7\u54c1\u63cf\u8ff0\u4e0e\u6280\u672f\u8d44\u6599\uff1b<\/li>\n\n\n\n<li>\u98ce\u9669\u8bc4\u4f30\u548c\u6d4b\u8bd5\u62a5\u544a\uff1b<\/li>\n\n\n\n<li>\u5408\u89c4\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8bc1\u660e\uff1b<\/li>\n\n\n\n<li>\u4e34\u5e8a\u6570\u636e\u6216\u6027\u80fd\u9a8c\u8bc1\uff08\u6839\u636e\u4ea7\u54c1\u7c7b\u578b\u4e0d\u540c\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u901a\u8fc7FDA\u8ba4\u8bc1\u540e\uff0c\u8bbe\u5907\u53ef\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"34_ISO_13485%E8%AE%A4%E8%AF%81\"><\/span>3.4 ISO 13485\u8ba4\u8bc1<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>ISO 13485\u662f\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff08ISO\uff09\u53d1\u5e03\u7684\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u9002\u7528\u4e8e\u8bbe\u8ba1\u3001\u751f\u4ea7\u3001\u5b89\u88c5\u548c\u670d\u52a1\u7684\u5404\u4e2a\u73af\u8282\u3002\u5bf9\u4e8e\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u751f\u4ea7\u5546\u6765\u8bf4\uff0cISO 13485\u8ba4\u8bc1\u662f\u8bc1\u660e\u5176\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7b26\u5408\u56fd\u9645\u8981\u6c42\u7684\u91cd\u8981\u8bc1\u4e66\u3002\u901a\u8fc7ISO 13485\u8ba4\u8bc1\u540e\uff0c\u4f01\u4e1a\u80fd\u591f\u5728\u5168\u7403\u8303\u56f4\u5185\u63d0\u5347\u5176\u4ea7\u54c1\u7684\u4fe1\u8a89\uff0c\u5c24\u5176\u5728\u6b27\u7f8e\u5e02\u573a\uff0cISO 13485\u8ba4\u8bc1\u6210\u4e3a\u8fdb\u5165\u9ad8\u7aef\u5e02\u573a\u7684\u5173\u952e\u8d44\u8d28\u4e4b\u4e00\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"35_RoHS%E4%B8%8EWEEE%E8%AE%A4%E8%AF%81\"><\/span>3.5 RoHS\u4e0eWEEE\u8ba4\u8bc1<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u968f\u7740\u73af\u4fdd\u610f\u8bc6\u7684\u63d0\u5347\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u8fd8\u9700\u8981\u7b26\u5408\u6b27\u76df\u7684\u300a\u9650\u5236\u4f7f\u7528\u6709\u5bb3\u7269\u8d28\u6307\u4ee4\u300b\uff08RoHS\uff09\u548c\u300a\u5e9f\u5f03\u7535\u6c14\u7535\u5b50\u8bbe\u5907\u6307\u4ee4\u300b\uff08WEEE\uff09\u3002\u8fd9\u4e9b\u8ba4\u8bc1\u8981\u6c42\u751f\u4ea7\u5546\u786e\u4fdd\u5176\u4ea7\u54c1\u4e2d\u4e0d\u542b\u6709\u8d85\u8fc7\u6cd5\u5b9a\u9650\u5236\u7684\u6709\u5bb3\u7269\u8d28\uff0c\u5982\u94c5\u3001\u6c5e\u3001\u9549\u7b49\uff0c\u4ee5\u4fdd\u62a4\u73af\u5883\u548c\u7528\u6237\u5065\u5eb7\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_%E5%8C%BB%E7%94%A8%E8%B6%85%E5%A3%B0%E6%B3%A2%E6%B8%85%E6%B4%97%E6%9C%BA%E7%9A%84%E6%80%A7%E8%83%BD%E6%A0%87%E5%87%86%E4%B8%8E%E5%AE%89%E5%85%A8%E8%A6%81%E6%B1%82\"><\/span>4. \u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u6027\u80fd\u6807\u51c6\u4e0e\u5b89\u5168\u8981\u6c42<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u9664\u4e86\u4e0a\u8ff0\u8d44\u8d28\u8ba4\u8bc1\u5916\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u8fd8\u9700\u8981\u6ee1\u8db3\u4e00\u7cfb\u5217\u6027\u80fd\u6807\u51c6\u548c\u5b89\u5168\u8981\u6c42\uff0c\u786e\u4fdd\u5176\u5728\u5b9e\u9645\u5e94\u7528\u4e2d\u7684\u6548\u679c\u4e0e\u5b89\u5168\u6027\u3002\u4f8b\u5982\uff0c\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u9891\u7387\u8303\u56f4\u3001\u529f\u7387\u63a7\u5236\u3001\u7a7a\u5316\u6548\u679c\u3001\u6e05\u6d17\u5747\u5300\u6027\u7b49\u90fd\u9700\u8981\u7b26\u5408\u56fd\u9645\u6807\u51c6\uff0c\u4ee5\u4fdd\u8bc1\u8bbe\u5907\u5728\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u7684\u6e05\u6d17\u6548\u7387\u548c\u5668\u68b0\u5b89\u5168\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_%E7%BB%93%E8%AE%BA\"><\/span>5. \u7ed3\u8bba<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5176\u5408\u89c4\u6027\u548c\u8ba4\u8bc1\u81f3\u5173\u91cd\u8981\u3002\u65e0\u8bba\u662f\u5728\u4e2d\u56fd\u3001\u6b27\u76df\u3001\u7f8e\u56fd\u8fd8\u662f\u5176\u4ed6\u5730\u533a\uff0c\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u751f\u4ea7\u548c\u9500\u552e\u90fd\u5fc5\u987b\u6ee1\u8db3\u5404\u56fd\u548c\u5730\u533a\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u5305\u62ec\u6ce8\u518c\u8ba4\u8bc1\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u4ee5\u53ca\u5176\u4ed6\u7279\u6b8a\u8ba4\u8bc1\u3002\u901a\u8fc7\u8fd9\u4e9b\u8d44\u8d28\u8ba4\u8bc1\uff0c\u80fd\u591f\u786e\u4fdd\u8bbe\u5907\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u53ca\u5408\u89c4\u6027\uff0c\u540c\u65f6\u4e5f\u4e3a\u751f\u4ea7\u5546\u6253\u5f00\u56fd\u9645\u5e02\u573a\u63d0\u4f9b\u4e86\u4fdd\u969c\u3002\u56e0\u6b64\uff0c\u4e86\u89e3\u5e76\u83b7\u53d6\u8fd9\u4e9b\u8d44\u8d28\u8ba4\u8bc1\u5bf9\u4e8e\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u751f\u4ea7\u5546\u800c\u8a00\u662f\u8fdb\u5165\u5e02\u573a\u3001\u8d62\u5f97\u6d88\u8d39\u8005\u4fe1\u4efb\u4ee5\u53ca\u4fdd\u969c\u516c\u5171\u5065\u5eb7\u7684\u5fc5\u8981\u6b65\u9aa4\u3002<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"750\" height=\"450\" src=\"https:\/\/www.jietaisonic.com\/wp-content\/uploads\/2025\/01\/2-16.jpg\"  class=\"wp-image-10720\" srcset=\"https:\/\/www.jietaisonic.com\/wp-content\/uploads\/2025\/01\/2-16.jpg 750w, https:\/\/www.jietaisonic.com\/wp-content\/uploads\/2025\/01\/2-16-300x180.jpg 300w, https:\/\/www.jietaisonic.com\/wp-content\/uploads\/2025\/01\/2-16-600x360.jpg 600w\" sizes=\"(max-width: 750px) 100vw, 750px\" title=\"\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8981\u6c42\u4e0e\u8ba4\u8bc1\u5206\u6790\" alt=\"\u533b\u7528\u8d85\u58f0\u6ce2\u6e05\u6d17\u673a\u7684\u8d44\u8d28\u8981\u6c42\u4e0e\u8ba4\u8bc1\u5206\u6790\" \/><\/figure><\/div>","protected":false},"excerpt":{"rendered":"<p>1. \u5f15\u8a00 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