{"id":4779,"date":"2020-09-08T18:33:52","date_gmt":"2020-09-08T10:33:52","guid":{"rendered":"https:\/\/www.ishopdea.com\/?p=4779"},"modified":"2020-11-18T14:14:14","modified_gmt":"2020-11-18T06:14:14","slug":"%e3%80%90%e5%be%ae%e7%94%9f%e7%89%a9%e5%ad%b8%e5%b0%88%e5%ae%b6%e8%aa%8c%ef%bc%9a%e5%8f%a3%e7%bd%a9%e6%a8%99%e6%ba%96%e5%b0%8f%e7%9f%a5%e8%ad%98%e3%80%91","status":"publish","type":"post","link":"https:\/\/www.ishopdea.com\/en\/2020\/09\/08\/%e3%80%90%e5%be%ae%e7%94%9f%e7%89%a9%e5%ad%b8%e5%b0%88%e5%ae%b6%e8%aa%8c%ef%bc%9a%e5%8f%a3%e7%bd%a9%e6%a8%99%e6%ba%96%e5%b0%8f%e7%9f%a5%e8%ad%98%e3%80%91\/","title":{"rendered":"\u3010\u5fae\u751f\u7269\u5b78\u5c08\u5bb6\u8a8c\uff1a\u53e3\u7f69\u6a19\u6e96\u5c0f\u77e5\u8b58\u3011"},"content":{"rendered":"\n

\u6587\uff1aDr. Horasis Leung\uff5c\u8b6f \uff1aishopdea\uff5c\u5716\uff1aWoody@eggshell\uff5c \u7de8\uff1aishopdea<\/p>\n\n\n\n

\u9632\u75ab\u671f\u9593\uff0c<\/p>\n\n\n\n

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<\/p>\n\n\n\n

\u7531\u65bcCOVID-19\u75c5\u6bd2\uff0c<\/p>\n\n\n\n

\u53e3\u7f69\u5df2\u6210\u70ba\u65e5\u5e38\u751f\u6d3b\u4e2d\u5fc5\u4e0d\u53ef\u7f3a\u5c11\u7684\u7269\u54c1\u3002<\/p>\n\n\n\n

\u5728\u77ed\u77ed\u516d\u500b\u6708\u5167\uff0c<\/p>\n\n\n\n

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\u6025\u65bc\u6eff\u8db3\u9019\u7a2e\u9700\u6c42\u3002<\/p>\n\n\n\n


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\u7f8e\u570b\u548c\u65e5\u672c\uff08ASTM F2100\uff09\uff0c\u6b50\u6d32\uff08EN 14683\uff09\uff0c\u4e2d\u570b\uff08YY0469\uff0cGB19083\uff09\uff0c\u53f0\u7063\uff08CNS 14774\uff09\u548c\u97d3\u570b\uff08KF\uff09\u5747\u6709\u4e0d\u540c\u7684\u6a19\u6e96\u53ca\u8981\u6c42\u3002<\/p>\n\n\n\n


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\u6700\u5e38\u898b\u7684\u8981\u6c42\u5982\u4e0b\uff1a <\/p>\n\n\n\n

\u96a8\u8457\u5404\u570b\u7684\u6a19\u6e96\u548c\u8981\u6c42\u4e0d\u65b7\u66f4\u65b0\uff0c<\/p>\n\n\n\n

\u6211\u5011\u4ea6\u9700\u8981\u4e86\u89e3\u5b83\u5011\u7684\u6539\u8b8a\u3002<\/p>\n\n\n\n

\u9019\u662fASTM\uff0cEN\u548cYY\u66f4\u65b0\u7248\u672c\u7684\u7c21\u8981\u6bd4\u8f03<\/p>\n\n\n\n

\"\"
\u88681: \u91ab\u7528\u53e3\u7f69\u6240\u7528\u6750\u6599\u6027\u80fd ASTM F2100 – 19<\/figcaption><\/figure>\n\n\n\n

*\u50c5\u5c07\u677f\u6578\u4f5c\u70ba\u5fae\u751f\u7269\u6307\u6a19\u6307\u793a\uff1a<\/p>\n\n\n\n

YY 0469\u7684\u5fae\u751f\u7269\u6a19\u6e96\u4e2d\u63d0\u53ca\u7684\uff0c<\/p>\n\n\n\n

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\u4f8b\u5982\uff0c\u5c0d\u65bc1\u7d1a\u5c4f\u969c\uff0cASTM\u6a19\u6e96\u5c07\u5176\u58d3\u529b\u5dee\u7570\u6e2c\u8a66\u7684\u8981\u6c42\u5f9e<40 Pa \/ cm2\u964d\u4f4e\u5230<50Pa \/ cm2\uff0c<\/p>\n\n\n\n

\u5982\u4e0b\u5716\u6240\u793a\uff1a<\/p>\n\n\n\n

\"\"
\u88682: \u91ab\u7528\u53e3\u7f69\u6240\u7528\u6750\u6599\u6027\u80fd ASTM F2100 – 11 (2018)<\/figcaption><\/figure>\n\n\n\n

\u964d\u4f4e\u8981\u6c42\u4f7f\u66f4\u591a\u5177\u6709\u826f\u597d\u904e\u6ffe\u80fd\u529b\u7684\u53e3\u7f69\u80fd\u901a\u904e\u6a19\u6e96\uff0c<\/p>\n\n\n\n

\u4f46\u537b\u56e0\u8981\u901a\u904e\u58d3\u529b\u6e2c\u8a66\u800c\u72a7\u7272\u4e86\u5176\u900f\u6c23\u6027\u3002 <\/p>\n\n\n\n

\u8207EN 14683\uff1a2005\u76f8\u6bd4\uff0cEN 14683\uff1a2019\u7684\u8981\u6c42\u9084\u9032\u884c\u4e86\u4fee\u6539\uff0c<\/p>\n\n\n\n

\u4ee5\u522a\u9664\u53e3\u7f69\u4e2d\u7684IR\u578b\u3002<\/p>\n\n\n\n

\u4f46\u662f\uff0c\u5728\u672b\u7aef\u537b\u6dfb\u52a0\u4e86\u4e00\u689d\u8a3b\u91cb\uff0c<\/p>\n\n\n\n

\u5c07\u60a3\u8005\u7684I\u578b\u53e3\u7f69\u8207\u5c08\u696d\u7684II\u578b\u53e3\u7f69\u5206\u958b\u3002 
<\/p>\n\n\n\n

\"\"
\u88683: \u91ab\u7528\u53e3\u7f69\u7684\u6027\u80fd\u8981\u6c42<\/figcaption><\/figure>\n\n\n\n

I\u578b\u91ab\u7528\u53e3\u7f69\u50c5\u61c9\u7528\u65bc\u60a3\u8005\u548c\u5176\u4ed6\u4eba\uff0c<\/p>\n\n\n\n

\u4ee5\u6e1b\u5c11\u611f\u67d3\u50b3\u64ad\u7684\u98a8\u96aa\uff0c<\/p>\n\n\n\n

\u7279\u5225\u662f\u5728\u6d41\u884c\u6216\u5927\u6d41\u884c\u7684\u60c5\u6cc1\u4e0b\u3002 <\/p>\n\n\n\n

I\u985e\u53e3\u7f69\u4e0d\u9069\u7528\u65bc\u91ab\u8b77\u4eba\u54e1\u5728\u624b\u8853\u5ba4\u6216\u5177\u6709\u985e\u4f3c\u8981\u6c42\u7684\u5176\u4ed6\u91ab\u7642\u74b0\u5883\u4e2d\u4f7f\u7528\u3002<\/p>\n\n\n\n


<\/p>\n\n\n\n

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\u4e16\u754c\u5404\u570b\u6b63\u8abf\u6574\u81ea\u5df1\u7684\u8981\u6c42\u4f86\u61c9\u5c0d\u9019\u9700\u6c42\u3002<\/p>\n\n\n\n

\u4ee5FDA\u70ba\u4f8b\uff1a\u7f8e\u570bFDA\u65bc2020\u5e743\u670824\u65e5\u70ba\u975eNIOSH\u6279\u51c6\u7684N95\u9632\u6bd2\u9762\u5177\u767c\u5e03\u4e86\u7dca\u6025\u4f7f\u7528\u6388\u6b0a\uff08EUA\uff09\u3002<\/p>\n\n\n\n

\u5b83\u9084\u6279\u51c6\u4e86\u81e8\u6642\u5f37\u5236\u57f7\u884c\u63aa\u65bd\u4ee5\u53ca\u7b26\u5408\u67d0\u4e9b\u6a19\u6e96\u7684\u53e3\u7f69\u548c\u53e3\u7f69\u7684\u71df\u92b7\u5efa\u8b70\u7d66\u5404\u91ab\u8b77\u4eba\u54e1\u3002  1<\/p>\n\n\n\n


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\u4f5c\u70ba\u6700\u7d42\u7522\u54c1\u7684\u6d88\u8cbb\u8005\uff0c<\/p>\n\n\n\n

\u6211\u5011\u4e0d\u50c5\u8981\u6aa2\u67e5\u6e2c\u8a66\u662f\u5426\u901a\u904e\u6216\u5931\u6557\uff0c<\/p>\n\n\n\n

\u800c\u4e14\u9084\u8981\u4e86\u89e3\u5230\u5e95\u6e2c\u8a66\u7d50\u679c\u610f\u5473\u8457\u4ec0\u9ebc\u3002  <\/p>\n\n\n\n


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\u6211\u5c07\u5617\u8a66\u5728\u4e0b\u4e00\u7bc7\u6587\u7ae0\u4e2d\u8ac7\u53ca\u6709\u95dc\u9999\u6e2f\u5728\u53e3\u7f69\u4e2d\u7684\u689d\u4f8b\u3002 <\/p>\n\n\n\n

\u5728\u6b64\u4e4b\u524d\uff0c\u5e0c\u671b\u5927\u5bb6\u7e7c\u7e8c\u52e4\u6d17\u624b\u3001\u6234\u53e3\u7f69\uff0c\u4fdd\u6301\u6e05\u6f54\u3002<\/p>\n\n\n\n

\u4fdd\u5b58\u4fe1\u5fc3\u53ca\u5b89\u5168\u3002<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Dr. Horasis Leung \uff5c \u5fae\u751f\u7269\u5b78\u5c08\u5bb6<\/p>\n\n\n\n

\u9999\u6e2f\u5927\u5b78\u5fae\u751f\u7269\u5b78\u535a\u58eb\u4ee5\u53ca\u7f8e\u570b\u5bc6\u897f\u6839\u5dde\u7acb\u5927\u5b78\u5de5\u696d\u5fae\u751f\u7269\u5b78\u78a9\u58eb\u3002\u5c08\u9580\u5f9e\u4e8b\u5404\u9805\u5fae\u751f\u7269\u5b78\u7814\u7a76\u3001\u751f\u7269\u79d1\u6280\u5be6\u9a57\uff0c\u4ee5\u53ca\u70ba\u5404\u884c\u696d\u7684\u7522\u54c1\uff08\u5305\u62ec\u5efa\u7bc9\u6750\u6599\u3001\u85e5\u54c1\u3001\u98df\u54c1\u3001\u751f\u7269\u91ab\u5b78\u548c\u74b0\u4fdd\u7522\u54c1\u7b49\uff09\u63d0\u4f9b\u6e2c\u8a66\u53ca\u8a8d\u8b49\u3002
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\u75ab\u60c5\u4e0d\u65b7\u53cd\u8986\u6ce2\u52d5\uff0c\u9999\u6e2f\u4eba\u88ab\u903c\u4e00\u76f4\u904e\u8457\u6234\u53e3\u7f69\u7684\u751f\u6d3b\u3002\u73fe\u6642\u53e3\u7f69\u5e02\u5834\u7684\u4f9b\u61c9\u548c\u7a2e\u985e\u8d8a\u4f86\u8d8a\u591a\uff0c\u5728\u9078\u8cfc\u53e3\u7f69\u6642\u9808\u7559\u795e\uff0c\u8a8d\u6e05\u570b\u969b\u6a19\u6e96\u548c\u8a8d\u8b49\uff0c\u63d0\u9632\u8ca8\u4e0d\u5c0d\u8fa6\u3002\u9577\u671f\u6234\u53e3\u7f69\u96e3\u514d\u611f\u5230\u4e0d\u5feb\uff0c\u5982\u6709\u9700\u8981\uff0c\u53ef\u5728\u53e3\u7f69\u4e0a\u6ef4\u4e0a\u8584\u8377\u7cbe\u6cb9\u4f86\u8212\u7de9\u4fb7\u4fc3\u611f\uff0c\u6216\u5728\u53e3\u7f69\u88e1\u653e\u7f6e\u6297\u83cc\u7d19\u5dfe\uff0c\u6e1b\u5c11\u53e3\u7f69\u5167\u5c64\u53d7\u6f6e\u3002<\/p>\n\n\n\n

\u8cc7\u6599\u4f86\u6e90\uff1a<\/p>\n\n\n\n

  1. https:\/\/www.fda.gov\/medical-devices\/emergency-use-authorizations-medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices<\/li><\/ol>\n\n\n","protected":false},"excerpt":{"rendered":"

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