{"id":657,"date":"2024-06-26T14:59:26","date_gmt":"2024-06-26T06:59:26","guid":{"rendered":"https:\/\/gvmmedical.com\/chinese\/?p=657"},"modified":"2024-06-26T14:59:26","modified_gmt":"2024-06-26T06:59:26","slug":"%e7%be%8e%e5%9b%bdfda%e6%9b%b4%e6%96%b0%e6%b3%95%e8%a7%84%e6%b8%85%e5%8d%95","status":"publish","type":"post","link":"https:\/\/gvmmedical.com\/chinese\/%e7%be%8e%e5%9b%bdfda%e6%9b%b4%e6%96%b0%e6%b3%95%e8%a7%84%e6%b8%85%e5%8d%95\/","title":{"rendered":"\u7f8e\u56fdFDA\u66f4\u65b0\u6cd5\u89c4\u6e05\u5355"},"content":{"rendered":"\n<p class=\"\">\u7f8e\u56fd\u5f53\u5730\u65f6\u95f46\u670824\u65e5\uff0cFDA\u66f4\u65b0\u4e86\u8ba4\u53ef\u6807\u51c6\u6e05\u5355\uff0c\u6e05\u5355\u7f16\u53f7\u4e3a062\u3002\u7279\u522b\u63d0\u8bf7\u6ce8\u610f\u4ee5\u4e0b\u51e0\u4e2a\u4e0e\u4e2d\u56fd\u751f\u4ea7\u5546\u76f8\u5173\u7684\u91cd\u8981\u4fe1\u606f\uff1a<\/p>\n\n\n\n<p class=\"\">1.\u5b89\u89c4\/\u6027\u80fd\u6d4b\u8bd5\u901a\u6807\u66f4\u65b0\u7248\u672c<\/p>\n\n\n\n<p class=\"\">IEC TS 60601\u20134\u20132 Edition 1.0 2024\u201303 Medical electrical equipment\u2014 Part 4\u20132: Guidance and interpretation\u2014Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. \u7535\u78c1\u6297\u6270<\/p>\n\n\n\n<p class=\"\">2.\u4e94\u4e2a\u5b89\u89c4\/\u6027\u80fd\u6d4b\u8bd5\u4e13\u6807\u66f4\u65b0\u7248\u672c<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\">ISO 80601\u20132\u201374 Second edition 2021\u201307 Medical electrical equipment\u2014Part 2\u201374: Particular requirements for basic safety and essential performance of respiratory humidifying equipment. \u547c\u5438\u6e7f\u5316\u88c5\u7f6e<\/li>\n\n\n\n<li class=\"\">IEC 60601\u20132\u201357 Edition 2.0 2023\u201307 Medical Electrical Equipment\u2014Part 2\u201357: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use\u975e\u6fc0\u5149\u5149\u6e90\u8bca\u65ad\u3001\u6cbb\u7597\u548c\u533b\u7f8e\u8bbe\u5907<\/li>\n\n\n\n<li class=\"\">IEC 60601\u20132\u201322 Edition 4.0 2019\u201311 Medical electrical equipment\u2014Part 2\u201322: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment \u91c7\u7528\u6fc0\u5149\u5149\u6e90\u7684\u8bca\u65ad\u3001\u6cbb\u7597\u548c\u533b\u7f8e\u8bbe\u5907<\/li>\n<\/ul>\n\n\n\n<p class=\"\">3.\u65b0\u589e\u7684\u4e13\u6807<\/p>\n\n\n\n<p class=\"\">ISO 80601-2-85:2021 (Edition 1.0) Medical electrical equipment: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment\u8111\u7ec4\u7ec7\u8840\u6c27\u4eea\u8bbe\u5907<\/p>\n\n\n\n<p class=\"\">\u8fd8\u6709\u4e00\u4e9b\u5173\u4e8e\u706d\u83cc\u548c\u8f6f\u4ef6\u76f8\u5173\u7684\u6807\u51c6\u66f4\u65b0\/\u65b0\u589e\u503c\u5f97\u5173\u6ce8\u3002<\/p>\n\n\n\n<p class=\"\">\u66f4\u591a\u8be6\u60c5\uff0c<a href=\"mailto:\u8bf7\u8054\u7cfbinfo@gvmmedical.com\">\u8bf7\u8054\u7cfbinfo@gvmmedical.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u5f53\u5730\u65f6\u95f46\u670824\u65e5\uff0cFDA\u66f4\u65b0\u4e86\u8ba4\u53ef\u6807\u51c6\u6e05\u5355\uff0c\u6e05\u5355\u7f16\u53f7\u4e3a062\u3002\u7279\u522b\u63d0\u8bf7\u6ce8\u610f\u4ee5\u4e0b\u51e0\u4e2a\u4e0e\u4e2d\u56fd\u751f\u4ea7\u5546\u76f8\u5173\u7684\u91cd\u8981 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