{"id":25568,"date":"2020-10-30T07:30:47","date_gmt":"2020-10-30T07:30:47","guid":{"rendered":"https:\/\/dev.ikonixasia.com\/?p=25568"},"modified":"2022-12-27T10:17:01","modified_gmt":"2022-12-27T10:17:01","slug":"is-your-iec-60601-1-knowledge-up-to-date","status":"publish","type":"post","link":"https:\/\/www.ikonixasia.com\/tw\/2020\/10\/is-your-iec-60601-1-knowledge-up-to-date\/","title":{"rendered":"\u9762\u5c0d\u91ab\u7642\u5b89\u898fIEC 60601-1\u5168\u65b0\u6539\u7248,\u4f60\u4e86\u89e3\u591a\u5c11?"},"content":{"rendered":"
\n
\n\t

\u3010EXTECH Explores\u3011<\/strong><\/h3>\n

 \u95b1\u8b80\u6642\u9593\u5927\u7d0410\u5206\u9418<\/span><\/h3>\n<\/div>\n<\/div><\/div>
<\/div><\/div>
\n
\n\t

\u662f\u6642\u5019\u66f4\u65b0\u60a8\u5c0dIEC 60601<\/strong>\u7684\u4e86\u89e3\u4e86!<\/strong><\/h2>\n

\u6c92\u4eba\u6562\u4fdd\u8b49\uff0c\u9019\u5834\u8086\u8650\u5168\u7403\u7684\u75ab\u60c5\u751a\u9ebc\u6642\u5019\u6703\u7d50\u675f\uff1b\u6211\u5011\u552f\u4e00\u80fd\u78ba\u5b9a\u7684\u662f\u524d\u7dda\u91ab\u8b77\u4eba\u54e1\u7121\u4e0d\u7aed\u76e1\u5168\u529b\u7684\u5728\u633d\u6551\u751f\u547d\u3002\u70ba\u4e86\u8b93\u91ab\u8b77\u4eba\u54e1\u7121\u5f8c\u9867\u4e4b\u6182\u7684\u5c0d\u6297\u75ab\u60c5\uff0c\u4ed6\u5011\u6240\u4f7f\u7528\u7684\u6bcf\u4e00\u90e8\u91ab\u7642\u8a2d\u5099\u90fd\u5fc5\u9808\u7981\u5f97\u8d77\u6700\u56b4\u683c\u7684\u8003\u9a57\u3002\u800c\u5c0d\u91ab\u7642\u8a2d\u5099\u5b89\u5168\u6709\u6c7a\u5b9a\u6027\u5f71\u97ff\u529b\u7684IEC 60601-1 (\u91ab\u7642\u96fb\u5668\u4e4b\u5b89\u5168\u548c\u6709\u6548\u6027\u8981\u6c42)\uff0c\u8fd1\u671f\u6709\u91cd\u8981\u7684\u66f4\u65b0 - \u7b2c3.2\u7248\u672c (Amendment 2)\u3002\u70ba\u5e6b\u52a9\u60a8\u5373\u6642\u638c\u63e1\u6700\u65b0\u8cc7\u8a0a\uff0c\u672c\u671f\u96fb\u5b50\u5831\u4e2d\u6211\u5011\u5c07\u5e36\u60a8\u6df1\u5165\u63a2\u8a0eIEC 60601-1 \u7b2c3.2\u7248\u672c\u4e2d\u6709\u95dc\u96fb\u5b50\u5b89\u5168\u7684\u6700\u65b0\u5167\u5bb9\u3002<\/p>\n

<\/h2>\n

\u54ea\u4e9b\u5167\u5bb9\u66f4\u65b0\u4e86?<\/strong><\/h2>\n

\u57283.2\u7248\u672c\u773e\u591a\u7684\u66f4\u65b0\u5167\u5bb9\u88e1\uff0c\u95dc\u65bcIEC 60950-1 (\u8cc7\u8a0a\u79d1\u6280\u7522\u54c1\u5b89\u5168\u4e4b\u4e00\u822c\u8981\u6c42) \u5373\u5c07\u88abIEC 62368-1 (\u5f71\u97f3\u8cc7\u8a0a\u901a\u8a0a\u79d1\u6280\u7522\u54c1\u4e4b\u5b89\u5168\u8981\u6c42) \u6240\u53d6\u4ee3\u7684\u76f8\u95dc\u66f4\u65b0\u503c\u5f97\u88ab\u6ce8\u610f\u7684,\u56e0\u70ba\u904e\u53bb\u7684\u7248\u672c\u4e2d\u63a1\u7528\u4e86 IEC 60950-1 \u7684\u64cd\u4f5c\u54e1\u4fdd\u8b77\u624b\u6bb5 (means of operator protection, MOOP)\u3002\u96a8\u8457IT\u8a2d\u5099\u5728\u91ab\u7642\u8a2d\u5099\u7cfb\u7d71\u4e2d\u9010\u6f38\u6210\u70ba\u91cd\u8981\u7684\u4e00\u90e8\u5206\uff0cIEC 60950-1 \u6a19\u6e96\u4e5f\u5df2\u5c07\u8fd1 30 \u5e74\u4e14\u5373\u5c07\u7d50\u675f, \u56e0\u6b64\u6709\u5fc5\u8981\u5728IEC 60950\u5168\u9762\u9000\u51fa\u570b\u969b\u6a19\u6e96\u524d\u5148\u505a\u5fc5\u8981\u7684\u5167\u5bb9\u8abf\u5408\uff0c\u4ee5\u5229\u8207IEC 62368\u63a5\u8ecc\u3002<\/p>\n

<\/h2>\n

\u66f4\u65b0\u5f8c\u7684\u5dee\u7570\u5728\u54ea?<\/strong><\/h2>\n

\u6700\u4e3b\u8981\u7684\u5f71\u97ff\u5728\u65bc\u91ab\u7642\u8a2d\u5099\u7684\u96fb\u6e90\u8a2d\u8a08\u8207\u914d\u7f6e\u5c07\u53d7IEC 60950-1\u6a19\u6e96\u898f\u7bc4\u3002\u5118\u7ba1\u9650\u5236\u6709\u6240\u589e\u52a0\uff0c\u672a\u4f86\u5728\u91ab\u7528\u96fb\u6e90\u8b8a\u58d3\u5668\u7684\u9078\u64c7\u4e0a\u6703\u65bcIEC 62368-1\u5c0e\u5165\u5f8c\u6709\u66f4\u9ad8\u7684\u81ea\u7531\u5ea6\u3002<\/p>\n

\u53e6\u4e00\u500b\u91cd\u5927\u6539\u8b8a\u662f\u64cd\u4f5c\u8005\u4fdd\u8b77(means of operator protection, MOOP)\u8207\u60a3\u8005\u4fdd\u8b77(means of patient protection, MOPP)\u4e4b\u9593\u7684\u95dc\u4fc2\u3002\u8996\u61c9\u7528\u689d\u4ef6\uff0c\u4ee5\u5f80\u5e38\u4f7f\u7528\u76842MOOP = 1MOPP\u901a\u5247\uff0c\u57283.2\u7248\u672c\u516c\u5e03\u4e4b\u5f8c\u53ef\u80fd\u4e0d\u518d\u6b63\u78ba\u3002\u9019\u9805\u6539\u8b8a\u6703\u5f71\u97ff\u90e8\u5206\u88dd\u7f6e\u7684\u4f7f\u7528\u689d\u4ef6\uff0c\u5982\u91ab\u7642\u8a2d\u5099\u7684\u96fb\u6e90\u4f9b\u61c9\u5668\u3002\u82e5\u60a8\u6709\u4efb\u4f55\u7591\u554f\uff0c\u8acb\u52d9\u5fc5\u67e5\u8a62\u6700\u65b0\u7248IEC 60601-1\u7684\u76f8\u95dc\u689d\u6587\uff0c\u6216\u8aee\u8a62\u5408\u683c\u7684\u5b89\u898f\u5c08\u5bb6\u3002<\/p>\n

<\/h2>\n

\u91dd\u5c0d\u672c\u6b21\u66f4\u65b0\uff0cEEC<\/strong>\u5df2\u505a\u597d\u842c\u5168\u6e96\u5099<\/strong><\/h2>\n

\u5728\u7b2c4\u8207\u7b2c5\u671f\u96fb\u5b50\u5831\u4e2d\uff0c\u6211\u5011\u8a0e\u8ad6\u904eIEC 60601\u6a19\u6e96\u4e2d\u63a5\u89f8\u96fb\u6d41\u6e2c\u8a66\u7684\u91cd\u8981\u6027\uff0c\u4e26\u8a73\u7d30\u4ecb\u7d39\u4e866\u7a2e\u4e0d\u540c\u985e\u578b\u7684\u6d29\u6f0f\u96fb\u6d41\u6e2c\u8a66\u61c9\u7528\u3002\u900f\u904e\u8207\u570b\u969b\u77e5\u540d\u6e2c\u8a66\u5be6\u9a57\u5ba4\u8207\u91ab\u7642\u8a2d\u5099\u5546\u591a\u5e74\u7684\u5408\u4f5c\u7d93\u9a57\uff0cEEC\u83ef\u5100\u96fb\u5b50\u81ea\u884c\u8a2d\u8a08\u7684\u4eba\u9ad4\u6a21\u64ec\u963b\u6297(MD)\u53ef\u4ee5\u5b8c\u6574\u61c9\u5c0d\u5404\u7a2e\u6e2c\u8a66\u689d\u4ef6\u8207\u8981\u6c42\uff0c\u4e26\u5df2\u59a5\u5584\u6db5\u84cb\u6700\u65b0\u7684IEC 62368-1\u6a19\u6e96\u3002<\/p>\n

\u70ba\u78ba\u4fdd\u7522\u54c1\u7b26\u5408\u6a19\u6e96\uff0c\u773e\u591a\u91ab\u7642\u8a2d\u5099\u696d\u8005\u5747\u9078\u64c7\u63a1\u7528EEC\u83ef\u5100\u96fb\u5b50ESA\u7cfb\u5217\u548c7630\u63a5\u89f8\u96fb\u6d41\u6e2c\u8a66\u5100\u9032\u884c\u6e2c\u8a66\u3002\u900f\u904e\u9078\u7528EEC\u83ef\u5100\u96fb\u5b50\u7522\u54c1\uff0c\u80fd\u78ba\u4fdd\u60a8\u64c1\u6709\u7b26\u5408\u6700\u65b0\u6a19\u6e96\u7684\u4eba\u9ad4\u6a21\u64ec\u963b\u6297\u96fb\u8def\uff1b\u540c\u6642\u4eba\u9ad4\u963b\u6297\u96fb\u8def\u5716\u5c07\u5373\u6642\u986f\u793a\u65bc\u87a2\u5e55\u4e0a\u4f9b\u9078\u64c7\u3001\u7121\u9808\u81ea\u884c\u8a18\u61b6\u8907\u96dc\u7684IEC\u5b89\u898f\u7de8\u865f\uff0c\u8b93\u6a19\u6e96\u6e2c\u8a66\u66f4\u52a0\u8f15\u9b06\u65b9\u4fbf\u3002\u53e6\u5177\u5099\u5f37\u5927\u7684\u9023\u7d50\u80fd\u529b\uff0c\u80fd\u4ee5\u7c21\u55ae\u76f4\u89c0\u7684\u64cd\u4f5c\u4e00\u7ad9\u5f0f\u5b8c\u6210\u6e2c\u8a66\uff0c\u9032\u4e00\u6b65\u63d0\u5347\u6e2c\u8a66\u6548\u7387\u3002<\/p>\n

\u96a8\u8457\u78ba\u8a3a\u4eba\u6578\u4e0d\u65b7\u6500\u5347\uff0c\u5c0d\u6297COVID-19\u7684\u6230\u5f79\u4ecd\u6301\u7e8c\u9032\u884c\u3002\u6b63\u56e0\u5982\u6b64\uff0c\u5168\u7403\u5c0d\u65bc\u91ab\u7642\u8a2d\u5099\u7684\u9700\u6c42\u5c07\u53ea\u589e\u4e0d\u6e1b\uff1b\u9762\u5c0d\u6301\u7e8c\u4e0a\u6f32\u7684\u9700\u6c42\uff0c\u91ab\u7642\u8a2d\u5099\u5ee0\u61c9\u59a5\u5584\u4e86\u89e3\u672c\u6b213.2\u7248\u672c\u4e4b\u5167\u5bb9\uff0c\u63d0\u524d\u505a\u597d\u6e96\u5099\u3002\u9762\u5c0d\u65b0\u7684\u6311\u6230\uff0c\u64c1\u6709\u8d85\u904e40\u5e74\u7522\u696d\u7d93\u9a57\u7684EEC\u83ef\u5100\u96fb\u5b50\uff0c\u5df2\u5c07\u6700\u65b0\u7684\u6a19\u6e96\u5168\u9762\u7d0d\u5165\u6211\u5011\u7684\u7522\u54c1\uff0c\u5728\u6297\u75ab\u4e4b\u6230\u4e2d\u52a9\u60a8\u4e00\u81c2\u4e4b\u529b!<\/p>\n

\u672c\u6587\u53c3\u8003\u6587\u7ae0:
\n1. https:\/\/www.johner-institute.com\/articles\/product-development\/2-amendment-to-iec-60601-1\/
\n2. https:\/\/etech.iec.ch\/issue\/2020-05\/iec-publishes-amendments-to-key-medical-device-standards<\/p>\n

EEC\u83ef\u5100\u96fb\u5b50\u4e26\u4e0d\u70ba\u5176\u5167\u5bb9\u8ca0\u4efb\u4f55\u8cac\u4efb\u3002\u6b32\u8a73\u7d30\u4e86\u89e3\u76f8\u95dc\u6a19\u6e96\u5167\u5bb9\uff0c\u8acb\u8cfc\u8cb7\u6700\u65b0\u7248\u7684IEC 60601\u3001\u6216\u8aee\u8a62\u5408\u683c\u7684\u7b2c\u4e09\u65b9\u5be6\u9a57\u5ba4\u3002<\/sub><\/p>\n<\/div>\n<\/div><\/div>

\n
\n\t

 <\/p>\n

\n

Issue 10 \u2013 October 2020<\/strong><\/h3>\n
\n

Extech Explore\u00a0<\/span>\u662fEEC <\/span>\u83ef\u5100\u96fb\u5b50\u6bcf\u6708\u5b9a\u671f\u51fa\u520a\u7684\u96fb\u5b50\u5831\uff0c\u5167\u5bb9\u6db5\u84cb\u8c50\u5bcc\u4e14\u5177\u6709\u898b\u89e3\u7684\u96fb\u5668\u6e2c\u8a66\u65b9\u6848\u548c\u61c9\u7528\u3001\u7522\u696d\u5b89\u898f\u8da8\u52e2\u4ee5\u53ca\u83ef\u5100\u96fb\u5b50\u6700\u65b0\u6d88\u606f\u3002\u795d\u60a8\u95b1\u8b80\u6109\u5feb\uff01<\/span><\/p>\n<\/div>\n

\n
\n

\u95dc\u65bc\u00a0<\/span>EEC <\/span>\u83ef\u5100\u96fb\u5b50<\/span><\/strong><\/p>\n

EEC <\/span>\u83ef\u5100\u96fb\u5b50 40<\/span>\u5e74\u4f86\u91dd\u5c0d\u5404\u7a2e\u884c\u696d\uff0c\u4e0d\u540c\u7522\u696d\u751f\u7522\u5c16\u7aef\u7684\u96fb\u5668\u5b89\u5168\u6e2c\u8a66\u5100\u548c\u4ea4\u6d41\u96fb\u6e90\u3002\u6211\u5011\u901a\u904e\u6240\u6709\u6e2c\u8a66\u61c9\u7528\u7a0b\u5e8f\uff0c\u6301\u7e8c\u63d0\u4f9b\u53ef\u9760\u7684\u7522\u54c1\u548c\u670d\u52d9\u8d0f\u5f97\u5ba2\u6236\u7684\u4fe1\u4efb\u3002<\/p>\n<\/div>\n

<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

\u3010EXTECH Explores\u3011  \u95b1\u8b80\u6642\u9593\u5927\u7d0410\u5206\u9418 \u662f\u6642\u5019\u66f4\u65b0\u60a8\u5c0dIEC 60601\u7684\u4e86\u89e3\u4e86 …<\/p>\n","protected":false},"author":1,"featured_media":32052,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33],"tags":[],"application":[],"all-solutions":[],"class_list":{"0":"post-25568","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-enewsletter-tw"},"acf":[],"_links":{"self":[{"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/posts\/25568","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/comments?post=25568"}],"version-history":[{"count":0,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/posts\/25568\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/media?parent=25568"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/categories?post=25568"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/tags?post=25568"},{"taxonomy":"application","embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/application?post=25568"},{"taxonomy":"all-solutions","embeddable":true,"href":"https:\/\/www.ikonixasia.com\/tw\/wp-json\/wp\/v2\/all-solutions?post=25568"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}