{"id":8645,"date":"2022-10-26T18:14:54","date_gmt":"2022-10-26T10:14:54","guid":{"rendered":"https:\/\/business.medtecs.com\/certification-requirements-for-medical-gloves\/"},"modified":"2023-07-19T10:40:30","modified_gmt":"2023-07-19T02:40:30","slug":"certification-requirements-for-medical-gloves","status":"publish","type":"post","link":"https:\/\/business-medtecs01.rcdmkt.com\/zh-hant\/certification-requirements-for-medical-gloves\/","title":{"rendered":"\u91ab\u7528\u624b\u5957\u7684\u8a8d\u8b49\u8981\u6c42\u662f\u4ec0\u9ebc\uff1f"},"content":{"rendered":"<p>\u91ab\u7642\u624b\u5957\u7684\u8a8d\u8b49\u8981\u6c42\u662f\u4ec0\u9ebc\uff1f\u5982\u679c\u4f60\u554f\u9019\u500b\u554f\u984c\uff0c\u4f60\u6709\u53ef\u80fd\u662f\u5728\u5c0b\u627e\u4e00\u500b\u5408\u683c\u7684\u4f9b\u61c9\u93c8\uff0c\u751f\u7522\u7d93\u904e\u8a8d\u8b49\u7684<a 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href=\"https:\/\/fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health\" target=\"_blank\" rel=\"noopener\">\u6587\u4ef6<\/a>\uff0c\u63d0\u4f9b\u4e86\u4e00\u9805\u653f\u7b56\uff0c\u4ee5\u5e6b\u52a9\u64f4\u5927\u5728COVID-19\u5927\u6d41\u884c\u671f\u9593\u70ba\u91ab\u8b77\u4eba\u54e1\u63d0\u4f9b\u7684\u624b\u8853\u670d\uff0c\u5305\u62ec\u9577\u888d\uff08togas\uff09\u3001\u982d\u7f69\u548c\u5916\u79d1\u91ab\u751f\u53ca\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u3002\u8a72\u653f\u7b56\u50c5\u5728\u885b\u751f\u8207\u516c\u773e\u670d\u52d9\u90e8\uff08HHS\uff09\u5ba3\u5e03\u7684\u8207COVID-19\u6709\u95dc\u7684\u516c\u5171\u885b\u751f\u7dca\u6025\u60c5\u6cc1\u671f\u9593\u6709\u6548\uff0c\u5305\u62ecHHS\u90e8\u9577\u505a\u51fa\u7684\u4efb\u4f55\u5ef6\u9577\u3002\u4e00\u822c\u4f86\u8aaa\uff0cFDA\u7684\u6307\u5c0e\u6587\u4ef6\u4e26\u4e0d\u69cb\u6210\u6cd5\u5f8b\u4e0a\u53ef\u57f7\u884c\u7684\u8cac\u4efb\uff0c\u800c\u53ea\u662f\u63cf\u8ff0\u8a72\u6a5f\u69cb\u76ee\u524d\u5c0d\u67d0\u4e00\u4e3b\u984c\u7684\u60f3\u6cd5\uff0c\u4e26\u61c9\u50c5\u88ab\u8996\u70ba\u5efa\u8b70\uff0c\u9664\u975e\u5f15\u7528\u5177\u9ad4\u7684\u76e3\u7ba1\u6216\u6cd5\u5b9a\u8981\u6c42\u3002<\/p>\n<p>\u6839\u64da\u8a72\u6307\u5c0e\u6587\u4ef6\uff0cFDA\u5c0d\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u548c\u5916\u79d1\u91ab\u751f\u624b\u5957\u63d0\u51fa\u4e86\u5177\u9ad4\u5efa\u8b70\u3002\u7e3d\u7684\u4f86\u8aaa\uff0cFDA\u5efa\u8b70\u91ab\u7642\u6a5f\u69cb\u9075\u5faa\u7f8e\u570b\u75be\u75c5\u63a7\u5236\u548c\u9810\u9632\u4e2d\u5fc3\uff08CDC\uff09\u767c\u5e03\u7684\u6709\u95dcCOVID-19\u75ab\u60c5\u671f\u9593\u61c9\u4f7f\u7528\u7684\u500b\u4eba\u9632\u8b77\u8a2d\u5099\uff08PPE\uff09\u7684\u73fe\u884c\u6307\u5357\u3002\u91ab\u7642\u4fdd\u5065\u96c7\u4e3b\u4e5f\u5fc5\u9808\u9075\u5b88\u8077\u696d\u5b89\u5168\u8207\u5065\u5eb7\u7ba1\u7406\u5c40\uff08OSHA\uff09\u7684\u6a19\u6e96\uff0c\u9019\u4e9b\u6a19\u6e96\u8981\u6c42\u4f7f\u7528\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u4f86\u4fdd\u8b77\u5de5\u4eba\uff0c\u4e26\u9069\u7528\u65bc\u50b3\u67d3\u75c5\u5371\u5bb3\u3002<\/p>\n<p>\u70ba\u4e86\u89e3\u6c7a\u5927\u6d41\u884c\u671f\u9593\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u548c\u5916\u79d1\u91ab\u751f\u624b\u5957\u7684\u77ed\u7f3a\u554f\u984c\uff0cFDA\u4e0d\u6253\u7b97\u53cd\u5c0d\u5206\u767c\u548c\u4f7f\u7528\u4e0d\u7b26\u5408\u5404\u81ea\u76e3\u7ba1\u8981\u6c42\u7684\u9019\u5169\u985e\u624b\u5957\uff0c\u53ea\u8981\u9019\u4e9b\u624b\u5957\u5728\u516c\u5171\u885b\u751f\u7dca\u6025\u60c5\u6cc1\u4e0b\u4e0d\u9020\u6210\u904e\u5ea6\u7684\u98a8\u96aa\u3002<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\">\u88681. FDA\u5c0d\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u548c\u5916\u79d1\u91ab\u751f\u624b\u5957\u7684\u76e3\u7ba1\u8981\u6c42<\/p>\n<table>\n<tbody>\n<tr>\n<td>\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>\u5916\u79d1\u91ab\u751f\u7684\u624b\u5957<\/td>\n<\/tr>\n<tr>\n<td>\u6839\u64daFD&amp;C\u6cd5\u6848\u7b2c510(k)\u689d\u548c21 CFR 807.81\uff0c\u4e8b\u5148\u63d0\u4ea4\u4e0a\u5e02\u524d\u901a\u77e5\u66f8<\/td>\n<td>\u6839\u64daFD&amp;C\u6cd5\u6848\u7b2c510(k)\u689d\u548c21 CFR 807.81\uff0c\u4e8b\u5148\u63d0\u4ea4\u4e0a\u5e02\u524d\u901a\u77e5\u66f8<\/td>\n<\/tr>\n<tr>\n<td>21 CFR 807\u4e2d\u7684\u8a3b\u518a\u548c\u4e0a\u5e02\u8981\u6c42<\/td>\n<td>21 CFR 807\u4e2d\u7684\u8a3b\u518a\u548c\u4e0a\u5e02\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>21 CFR 820\u4e2d\u7684\u8cea\u91cf\u9ad4\u7cfb\u689d\u4f8b\u8981\u6c42<\/td>\n<td>21 CFR\u7b2c830\u90e8\u5206\u548c21 CFR\u7b2c801.20\u90e8\u5206\u7684\u552f\u4e00\u8a2d\u5099\u8b58\u5225\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>21 CFR\u7b2c806\u90e8\u5206\u4e2d\u7684\u66f4\u6b63\u548c\u522a\u9664\u7684\u5831\u544a<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>21 CFR\u7b2c830\u90e8\u5206\u548c21 CFR\u7b2c801.20\u90e8\u5206\u7684\u552f\u4e00\u8a2d\u5099\u8b58\u5225\u8981\u6c42<\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\">\u88682. FDA\u76ee\u524d\u8a8d\u70ba\uff0c\u7576\u6eff\u8db3\u4ee5\u4e0b\u8981\u6c42\u6642\uff0c\u4e0d\u6703\u5c0d\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u548c\u5916\u79d1\u91ab\u751f\u624b\u5957\u9020\u6210\u4e0d\u7576\u7684\u98a8\u96aa\uff1a<\/p>\n<table>\n<tbody>\n<tr>\n<td>\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>\u5916\u79d1\u91ab\u751f\u7684\u624b\u5957<\/td>\n<\/tr>\n<tr>\n<td>\u8a72\u7522\u54c1\u5305\u62ec\u7684\u6a19\u7c64\u6e96\u78ba\u5730\u63cf\u8ff0\u4e86\u8a72\u7522\u54c1\u70ba &#8220;\u7121\u7c89\u624b\u5957&#8221;\uff08\u76f8\u5c0d\u65bc\u5916\u79d1\u91ab\u751f\u6216\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u800c\u8a00\uff09\uff0c\u6e96\u78ba\u5730\u63cf\u8ff0\u4e86\u5176\u7368\u7acb\u5305\u88dd\u6642\u7684\u7121\u83cc\u72c0\u614b\uff08\u975e\u7121\u83cc\uff09\uff0c\u6c92\u6709\u8072\u7a31\u8a72\u7522\u54c1\u4e0d\u542b\u67d0\u7a2e\u7279\u5b9a\u6750\u6599\uff08\u5982\u7121\u4e73\u81a0\uff09\uff0c\u4e26\u5305\u62ec\u4e00\u4efd\u8207\u8eab\u9ad4\u63a5\u89f8\u7684\u6750\u6599\u6e05\u55ae\u3002<\/td>\n<td>\u8a72\u7522\u54c1\u7b26\u5408\u8207\u5171\u8b58\u6a19\u6e96ASTM D3577\u4e00\u81f4\u7684\u6a19\u6e96\u898f\u683c\uff1a \u6a61\u81a0\u5916\u79d1\u624b\u5957\u7684\u6a19\u6e96\u898f\u7bc4\u3002<\/td>\n<\/tr>\n<tr>\n<td>\u8a72\u7522\u54c1\u5305\u62ec\u5e36\u6709\u4e00\u822c\u8072\u660e\u7684\u6a19\u7c64\uff0c\u4e26\u63d0\u51fa\u5efa\u8b70\uff0c\u4ee5\u5145\u5206\u964d\u4f4e\u4f7f\u7528\u98a8\u96aa\uff0c\u4f8b\u5982\uff0c\u95dc\u65bc\u672a\u7d93FDA\u6279\u51c6\u7684\u8a2d\u5099\u7684\u4e00\u822c\u8072\u660e\uff0c\u4e26\u5efa\u8b70\u4e0d\u8981\u4f7f\u7528\uff1a\u7576\u6709FDA\u6279\u51c6\u7684\u624b\u5957\u6642\uff0c\u5728\u624b\u8853\u74b0\u5883\u6216\u53ef\u80fd\u5927\u91cf\u63a5\u89f8\u6db2\u9ad4\u8eab\u9ad4\u6216\u5176\u4ed6\u5371\u96aa\u6db2\u9ad4\u7684\u5730\u65b9\uff0c\u4ee5\u53ca\u5728\u611f\u67d3\u98a8\u96aa\u6c34\u5e73\u9ad8\u7684\u81e8\u5e8a\u74b0\u5883\u3002<\/td>\n<td>\u8a72\u7522\u54c1\u5305\u62ec\u7684\u6a19\u7c64\u6e96\u78ba\u5730\u63cf\u8ff0\u4e86\u8a72\u7522\u54c1\u70ba\u975e\u7c89\u672b\u72c0\uff0c\u6e96\u78ba\u5730\u63cf\u8ff0\u4e86\u5176\u7121\u83cc\u72c0\u614b\uff08\u7121\u83cc\uff09\u548c\u6240\u4f7f\u7528\u7684\u6ec5\u83cc\u65b9\u6cd5\uff0c\u6c92\u6709\u8072\u7a31\u8a72\u7522\u54c1\u4e0d\u542b\u67d0\u7a2e\u7279\u5b9a\u6750\u6599\uff08\u4f8b\u5982\uff0c\u4e0d\u542b\u4e73\u81a0\uff09\uff0c\u4e26\u5305\u62ec\u4e00\u4efd\u8207\u8eab\u9ad4\u63a5\u89f8\u7684\u6750\u6599\u6e05\u55ae\u3002<\/td>\n<\/tr>\n<tr>\n<td>\u9451\u65bc\u516c\u5171\u885b\u751f\u7dca\u6025\u60c5\u6cc1\uff0c\u8a72\u7522\u54c1\u4e0d\u7528\u65bc\u4efb\u4f55\u6703\u9020\u6210\u904e\u5ea6\u98a8\u96aa\u7684\u7528\u9014\uff0c\u4f8b\u5982\uff0c\u6a19\u7c64\u4e0d\u5305\u62ec\u8207\u5316\u7642\u85e5\u7269\u3001\u82ac\u592a\u5c3c\u548c\u5176\u4ed6\u963f\u7247\u985e\u85e5\u7269\u7684\u7528\u9014\uff0c\u9810\u9632\u904e\u654f\u6216\u76ae\u708e\u7684\u7528\u9014\uff0c\u6297\u83cc\u6216\u6297\u75c5\u6bd2\u4fdd\u8b77\u7684\u7528\u9014\uff0c\u6216\u9810\u9632\u6216\u6e1b\u5c11\u611f\u67d3\u7684\u7528\u9014\u3002<\/td>\n<td>\u8a72\u7522\u54c1\u5305\u62ec\u5e36\u6709\u4e00\u822c\u8072\u660e\u7684\u6a19\u7c64\uff0c\u4e26\u63d0\u51fa\u5efa\u8b70\uff0c\u4ee5\u5145\u5206\u964d\u4f4e\u4f7f\u7528\u98a8\u96aa\uff0c\u4f8b\u5982\uff0c\u95dc\u65bc\u672a\u7d93FDA\u6279\u51c6\u7684\u8a2d\u5099\u7684\u4e00\u822c\u8072\u660e\uff0c\u4ee5\u53ca\u5efa\u8b70\u5728\u6709FDA\u6279\u51c6\u7684\u5916\u79d1\u91ab\u751f\u624b\u5957\u6642\u4e0d\u8981\u4f7f\u7528\u3002<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>\u9451\u65bc\u516c\u5171\u885b\u751f\u7dca\u6025\u60c5\u6cc1\uff0c\u8a72\u7522\u54c1\u4e0d\u7528\u65bc\u4efb\u4f55\u6703\u9020\u6210\u904e\u5ea6\u98a8\u96aa\u7684\u7528\u9014\uff0c\u4f8b\u5982\uff0c\u6a19\u7c64\u4e0d\u5305\u62ec\u8207\u5316\u7642\u85e5\u7269\u3001\u82ac\u592a\u5c3c\u548c\u5176\u4ed6\u963f\u7247\u985e\u85e5\u7269\u7684\u7528\u9014\uff0c\u9810\u9632\u904e\u654f\u6216\u76ae\u708e\u7684\u7528\u9014\uff0c\u6297\u83cc\u6216\u6297\u75c5\u6bd2\u4fdd\u8b77\u7684\u7528\u9014\uff0c\u6216\u9810\u9632\u6216\u6e1b\u5c11\u611f\u67d3\u7684\u7528\u9014\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>\u6700\u5f8c\uff0cFDA\u610f\u8b58\u5230\uff0c\u7576\u6c92\u6709\u8af8\u5982FDA\u6279\u51c6\u7684\u624b\u8853\u670d\u3001\u5176\u4ed6\u624b\u8853\u670d\u88dd\u548c\/\u6216\u624b\u5957\u7684\u66ff\u4ee3\u54c1\u6642\uff0c\u500b\u4eba\uff0c\u5305\u62ec\u91ab\u7642\u4fdd\u5065\u5c08\u696d\u4eba\u58eb\uff0c\u53ef\u80fd\u6703\u5373\u8208\u88fd\u4f5c\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u3002\u7576\u6c92\u6709\u66ff\u4ee3\u7269\uff0c\u5982FDA\u6279\u51c6\u7684\u624b\u8853\u8863\u3001\u5176\u4ed6\u624b\u8853\u670d\u548c\/\u6216\u624b\u5957\u6642\uff0cFDA\u4e0d\u6253\u7b97\u53cd\u5c0d\u500b\u4eba\u5206\u767c\u548c\u4f7f\u7528\u7c21\u6613\u7684\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>FDA\u7684\u653f\u7b56\u9069\u7528\u65bc\u54ea\u4e9b\u985e\u578b\u7684\u624b\u5957\uff1f<\/h2>\n<p>\u7576\u624b\u5957\u7b26\u5408\u300a\u806f\u90a6\u85e5\u54c1\u548c\u72af\u7f6a\u6cd5\u300b\u7b2c201(h)\u689d\u898f\u5b9a\u7684\u8a2d\u5099\u5b9a\u7fa9\u6642\uff0c\u5b83\u5011\u5c31\u662f\u8a2d\u5099\u3002\u6839\u64daFD&amp;C\u6cd5\u6848\u7b2c201(h)\u689d\uff0c\u7576\u9019\u4e9b\u7522\u54c1\u7528\u65bc\u8a3a\u65b7\u75be\u75c5\u6216\u5176\u4ed6\u60c5\u6cc1\uff0c\u6216\u7528\u65bc\u6cbb\u6108\u3001\u6e1b\u8f15\u3001\u6cbb\u7642\u6216\u9810\u9632\u75be\u75c5\u6642\uff0c\u5b83\u5011\u5c31\u662f\u8a2d\u5099\u3002\u6b64\u985e\u8a2d\u5099\u9700\u8981\u9075\u5faaFDA\u7684\u71df\u92b7\u6388\u6b0a\u548cFD&amp;C\u6cd5\u6848\u7684\u5176\u4ed6\u8981\u6c42\u3002\u5728\u8a55\u4f30\u624b\u5957\u7522\u54c1\u662f\u5426\u7528\u65bc\u91ab\u7642\u76ee\u7684\u6642\uff0cFDA\u5c07\u8003\u616e\uff0c\u9664\u5176\u4ed6\u56e0\u7d20\u5916\uff0c\u662f\u5426\uff1a<\/p>\n<ol>\n<li aria-level=\"1\">\u88ab\u6a19\u660e\u6216\u4ee5\u5176\u4ed6\u65b9\u5f0f\u6253\u7b97\u7531\u4fdd\u5065\u5c08\u696d\u4eba\u54e1\u4f7f\u7528<\/li>\n<li aria-level=\"1\">\u88ab\u8cbc\u4e0a\u6a19\u7c64\u6216\u4ee5\u5176\u4ed6\u65b9\u5f0f\u7528\u65bc\u885b\u751f\u4fdd\u5065\u8a2d\u65bd\u6216\u74b0\u5883\u4e2d<\/li>\n<li aria-level=\"1\">\u5305\u62ec\u4efb\u4f55\u85e5\u7269\u3001\u751f\u7269\u88fd\u5291\u6216\u6297\u5fae\u751f\u7269\/\u6297\u75c5\u6bd2\u88fd\u5291<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>\u5177\u9ad4\u4f86\u8aaa\uff0cFDA\u7684\u653f\u7b56\u9069\u7528\u65bc\u4ee5\u4e0b\u985e\u578b\u7684\u624b\u5957\uff1a<\/p>\n<table>\n<tbody>\n<tr>\n<td><b>\u624b\u5957\u985e\u578b<\/b><\/td>\n<td><b>\u7522\u54c1\u4ee3\u78bc<\/b><\/td>\n<\/tr>\n<tr>\n<td>\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>FMC<\/td>\n<\/tr>\n<tr>\n<td>\u4e73\u81a0\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>LYY<\/td>\n<\/tr>\n<tr>\n<td>\u805a\u5408\u7269\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>LZA<\/td>\n<\/tr>\n<tr>\n<td>\u624b\u6307\u5957<\/td>\n<td>LZB<\/td>\n<\/tr>\n<tr>\n<td>PVC\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>LYZ<\/td>\n<\/tr>\n<tr>\n<td>\u7121\u7c89\u9280\u81a0\u7c89\u6a61\u81a0\u6aa2\u67e5\u624b\u5957<\/td>\n<td>OIG<\/td>\n<\/tr>\n<tr>\n<td>\u7121\u7c89\u805a\u6c2f\u4e01\u70ef\u60a3\u8005\u6aa2\u67e5\u624b\u5957<\/td>\n<td>OPC<\/td>\n<\/tr>\n<tr>\n<td>\u9632\u8f3b\u5c04\u91ab\u7528\u624b\u5957<\/td>\n<td>OPH<\/td>\n<\/tr>\n<tr>\n<td>\u7279\u7a2e\u75c5\u4eba\u6aa2\u67e5\u624b\u5957<\/td>\n<td>LZC<\/td>\n<\/tr>\n<tr>\n<td>\u5916\u79d1\u91ab\u751f\u624b\u5957<\/td>\n<td>KGO<\/td>\n<\/tr>\n<tr>\n<td>\u7121\u7c89\u975e\u5929\u7136\u6a61\u81a0\u4e73\u81a0\u5916\u79d1\u91ab\u751f\u624b\u5957<\/td>\n<td>OPA<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>FDA\u7684\u653f\u7b56\u4e0d\u9069\u7528\u65bc\u7c89\u672b\u72c0\u5916\u79d1\u91ab\u751f\u624b\u5957\u3001\u7c89\u672b\u72c0\u75c5\u4eba\u6aa2\u67e5\u624b\u5957\u548c\u7528\u65bc\u6f64\u6ed1\u5916\u79d1\u91ab\u751f\u624b\u5957\u7684\u53ef\u5438\u6536\u7c89\u672b\u3002\u6839\u64da21 CFR 895.102\u548c895.103\uff0c\u9019\u4e9b\u7522\u54c1\u662f\u88ab\u7981\u6b62\u7684\u8a2d\u5099\uff0c\u6c92\u6709\u8cc7\u683c\u5728\u7f8e\u570b\u92b7\u552e\u3002<\/p>\n<p><b>\u00a0<\/b><\/p>\n<h2>\u54ea\u4e9b\u91ab\u7528\u624b\u5957\u662f\u901a\u904eFDA\u8a8d\u8b49\u7684\uff1f<\/h2>\n<p>\u91ab\u7528\u624b\u5957\u88abFDA\u5217\u70ba\u7b2c\u4e00\u985e\u4fdd\u7559\u91ab\u7642\u5668\u68b0\uff0c\u9700\u8981<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\" target=\"_blank\" rel=\"noopener\">510\uff08K\uff09<\/a>\u4e0a\u5e02\u524d\u901a\u77e5\u3002 510(K)\u662f\u5411FDA\u63d0\u4ea4\u7684\u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u4ee5\u8b49\u660e\u5c07\u8981\u4e0a\u5e02\u7684\u8a2d\u5099\u8207\u7121\u9700\u4e0a\u5e02\u524d\u6279\u51c6\u7684\u5408\u6cd5\u4e0a\u5e02\u8a2d\u5099\u4e00\u6a23\u5b89\u5168\u548c\u6709\u6548\u3002 FDA\u5be9\u67e5\u9019\u4e9b\u8a2d\u5099\u4ee5\u78ba\u4fdd\u7b26\u5408\u6027\u80fd\u6a19\u6e96\uff0c\u5982\u9632\u6f0f\u3001\u6297\u6495\u88c2\u548c\u751f\u7269\u76f8\u5bb9\u6027\u3002\u8981\u78ba\u5b9aFDA\u6279\u51c6\u7684\u91ab\u7528\u624b\u5957\uff0c\u8acb\u4f7f\u7528\u4e0a\u8868\u4e2d\u5217\u51fa\u7684\u91ab\u7528\u624b\u5957\u7684\u7522\u54c1\u4ee3\u78bc\u641c\u7d22510\uff08k\uff09\u4e0a\u5e02\u524d\u901a\u77e5\u6578\u64da\u5eab\u3002<\/p>\n<p><b>\u00a0<\/b><\/p>\n<h2>\u624b\u5957\u7684CE\u8a8d\u8b49<\/h2>\n<p>CE\u8a8d\u8b49\u6216CE\u6a19\u8a8c\u662f\u7531\u5b57\u6bcd &#8220;CE &#8220;\u7d44\u6210\u7684\u5408\u683c\u6a19\u8a8c\uff0c\u5b83\u662f &#8220;conformit\u00e9 europ\u00e9enne&#8221;\uff08\u6cd5\u8a9e\uff0c\u5373\u6b50\u6d32\u5408\u683c\uff09\u7684\u7e2e\u5beb\u3002\u901a\u904e\u8cbc\u4e0aCE\u6a19\u8a8c\uff0c\u88fd\u9020\u5546\u8072\u660e\u5176\u7522\u54c1\u7b26\u5408\u6b50\u76df\uff08EU\uff09\u95dc\u65bc\u5065\u5eb7\u3001\u5b89\u5168\u548c\u74b0\u5883\u4fdd\u8b77\u7684\u6240\u6709\u6cd5\u5f8b\u8981\u6c42\u3002 CE\u6a19\u8b58\u5c0d\u67d0\u4e9b\u985e\u5225\u7684\u7522\u54c1\u662f\u5f37\u5236\u6027\u7684\uff0c\u5982\u91ab\u7642\u8a2d\u5099\u548c\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u3002<\/p>\n<p>\u5728\u5e02\u5834\u4e0a\u92b7\u552e\u4e4b\u524d\uff0c\u88fd\u9020\u5546\u6709\u8cac\u4efb\u6838\u5be6\u5176\u7522\u54c1\u662f\u5426\u7b26\u5408\u76f8\u95dc\u8981\u6c42\u3002\u5728\u67d0\u4e9b\u60c5\u6cc1\u4e0b\uff0c\u9700\u8981\u7531\u6307\u5b9a\u7684\u7b2c\u4e09\u65b9\u5408\u683c\u8a55\u4f30\u6a5f\u69cb\u5c0d\u7522\u54c1\u9032\u884c\u6aa2\u67e5\u3002<\/p>\n<p>CE\u6a19\u8a8c\u7acb\u6cd5\u7d71\u4e00\u4e86\u6574\u500b\u6b50\u6d32\u7684\u7522\u54c1\u8981\u6c42\u3002\u4e00\u65e6\u88fd\u9020\u5546\u7372\u5f97\u52a0\u8cbcCE\u6a19\u8a8c\u7684\u6b0a\u5229\uff0c\u5176\u7522\u54c1\u5c31\u53ef\u4ee5\u5728\u6240\u6709\u6b50\u76df\u570b\u5bb6\u81ea\u7531\u9032\u5165\u548c\u6d41\u901a\uff0c\u800c\u7121\u9700\u984d\u5916\u7684\u8981\u6c42\u6216\u8a8d\u8b49\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>EN\u6a19\u6e96<\/h2>\n<p>EN\u662f &#8220;Europ\u00e4ische Norm&#8221;\uff08\u5fb7\u8a9e &#8220;\u6b50\u6d32\u898f\u7bc4&#8221;\uff09\u7684\u7e2e\u5beb\uff0c\u5373\u6b50\u6d32\u6a19\u6e96\uff0c\u5b83\u662f\u7531\u4e09\u500b\u6b50\u6d32\u6a19\u6e96\u7d44\u7e54\uff08\u6b50\u6d32\u6a19\u6e96\u5316\u59d4\u54e1\u6703\uff08CEN\uff09\u3001\u6b50\u6d32\u96fb\u5de5\u6a19\u6e96\u5316\u59d4\u54e1\u6703\uff08CENELEC\uff09\u6216\u6b50\u6d32\u96fb\u4fe1\u6a19\u6e96\u5354\u6703\uff08ETSI\uff09\uff09\u4e4b\u4e00\u6279\u51c6\u7684\u4e00\u7cfb\u5217\u4e0d\u540c\u7684\u7522\u54c1\u3001\u751f\u7522\u904e\u7a0b\u3001\u670d\u52d9\u6216\u6e2c\u8a66\u65b9\u6cd5\u7684\u6280\u8853\u6a19\u6e96\u3002<\/p>\n<p>\u4ee5\u4e0b\u662f\u624b\u5957\u7684\u4e00\u4e9bEN\u6a19\u6e96\uff1a<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 420:2003 \u9632\u8b77\u624b\u5957 &#8211; \u4e00\u822c\u8981\u6c42\u548c\u6e2c\u8a66\u65b9\u6cd5\u7bc4\u570d<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9069\u7528\u65bc\u6240\u6709\u9632\u8b77\u624b\u5957\u7684\u624b\u5957\u8a2d\u8a08\u548c\u7d50\u69cb\u3001\u624b\u5957\u6750\u6599\u7684\u6297\u6c34\u7a7f\u900f\u6027\u3001\u7121\u5bb3\u6027\u3001\u8212\u9069\u6027\u548c\u6548\u7387\u3001\u6a19\u8b58\u548c\u88fd\u9020\u5546\u63d0\u4f9b\u7684\u8a0a\u606f\u7684\u4e00\u822c\u8981\u6c42\u548c\u76f8\u95dc\u6e2c\u8a66\u7a0b\u5e8f\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u4fdd\u8b77\u6027\u624b\u5957\uff0c\u5b83\u4e5f\u53ef\u4ee5\u9069\u7528\u65bc\u624b\u81c2\u4fdd\u8b77\u5668\u548c\u6c38\u4e45\u7d0d\u5165\u5b89\u5168\u6bbc\u7684\u624b\u5957\u3002<\/p>\n<p>*\u8a72\u6a19\u6e96\u65bc2009\u5e7411\u670811\u65e5\u88ab\u64a4\u92b7\uff0c\u5f8c\u4f86\u88ab<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:40942&amp;cs=1C21E26549F149E67BF8109D7E773052E\" target=\"_blank\" rel=\"noopener\">EN ISO 21420:2020<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 374-1:2003 \u9632\u79a6\u5316\u5b78\u54c1\u548c\u5fae\u751f\u7269\u7684\u9632\u8b77\u624b\u5957 &#8211; \u7b2c1\u90e8\u5206\uff1a\u8853\u8a9e\u548c\u6027\u80fd\u8981\u6c42<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u4fdd\u8b77\u4f7f\u7528\u8005\u514d\u53d7\u5316\u5b78\u54c1\u548c\/\u6216\u5fae\u751f\u7269\u5f71\u97ff\u7684\u624b\u5957\u7684\u8981\u6c42\uff0c\u4e26\u5b9a\u7fa9\u4e86\u4f7f\u7528\u7684\u8853\u8a9e\u3002\u672c\u6a19\u6e96\u61c9\u8207EN 420\u4e00\u8d77\u4f7f\u7528\uff0c\u4e0d\u898f\u5b9a\u5c0d\u4efb\u4f55\u6a5f\u68b0\u5371\u96aa\u7684\u4fdd\u8b77\u8981\u6c42\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u65e8\u5728\u4fdd\u8b77\u4f7f\u7528\u8005\u514d\u53d7\u5316\u5b78\u54c1\u98db\u6ffa\u5371\u5bb3\u7684\u624b\u5957\u3002\u5316\u5b78\u54c1\u98db\u6ffa\u4ecd\u7136\u53ef\u80fd\u6ef2\u900f\u5230\u624b\u5957\u4e2d\uff0c\u5c0d\u4f7f\u7528\u8005\u9020\u6210\u50b7\u5bb3\uff0c\u56e0\u6b64\u6700\u597d\u53ea\u4f7f\u7528\u88fd\u9020\u5546\u80fd\u63d0\u4f9b\u5316\u5b78\u54c1\u6ef2\u900f\u6578\u64da\u7684\u624b\u5957\u3002<\/p>\n<p>*\u672c\u6a19\u6e96\u5df2\u65bc2016\u5e7411\u670823\u65e5\u64a4\u92b7\uff0c\u88ab<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:37611&amp;cs=101646DABFD9FDA4D6F9DAD3D4916FC78\" target=\"_blank\" rel=\"noopener\">EN ISO 374-1:2016<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 374-2:2003 \u9632\u79a6\u5316\u5b78\u54c1\u548c\u5fae\u751f\u7269\u7684\u9632\u8b77\u624b\u5957 &#8211; \u7b2c2\u90e8\u5206\uff1a\u6297\u7a7f\u900f\u6027\u7684\u6e2c\u5b9a<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u8b77\u5316\u5b78\u54c1\u548c\/\u6216\u5fae\u751f\u7269\u7684\u624b\u5957\u7684\u6297\u7a7f\u900f\u6027\u7684\u6e2c\u8a66\u65b9\u6cd5\u3002\u76ee\u524d\uff0c\u4eba\u5011\u8a8d\u70ba\uff0c\u6309\u7167EN374\u6a19\u51c6\u9032\u884c\u6e2c\u8a66\u6642\uff0c\u6297\u7a7f\u900f\u6027\u5f37\u7684\u624b\u5957\u5c07\u5f62\u6210\u5c0d\u5fae\u751f\u7269\u5371\u5bb3\u7684\u6709\u6548\u5c4f\u969c\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u6b62\u5316\u5b78\u54c1\u548c\u5fae\u751f\u7269\u7684\u4fdd\u8b77\u6027\u624b\u5957\u3002<\/p>\n<p>*\u8a72\u6a19\u6e96\u5df2\u65bc2014\u5e7412\u670817\u65e5\u64a4\u92b7\uff0c\u96a8\u5f8c\u88ab<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:65845&amp;cs=1E705338C0648D96ED537DC60C8A0CE55\" target=\"_blank\" rel=\"noopener\">EN ISO 374-2:2019<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 374-3:2003 \u9632\u79a6\u5316\u5b78\u54c1\u548c\u5fae\u751f\u7269\u7684\u9632\u8b77\u624b\u5957 &#8211; \u7b2c3\u90e8\u5206\uff1a\u8010\u5316\u5b78\u54c1\u6ef2\u900f\u6027\u7684\u6e2c\u5b9a<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u8b77\u624b\u5957\u6750\u6599\u5728\u9023\u7e8c\u63a5\u89f8\u689d\u4ef6\u4e0b\u5c0d\u6f5b\u5728\u5371\u96aa\u7684\u975e\u6c23\u614b\u5316\u5b78\u54c1\u6ef2\u900f\u7684\u62b5\u6297\u529b\u3002\u672c\u6a19\u6e96\u5f37\u8abf\uff0c\u8a72\u8a66\u9a57\u4e26\u4e0d\u4ee3\u8868\u4f7f\u7528\u4e2d\u53ef\u80fd\u51fa\u73fe\u7684\u689d\u4ef6\uff0c\u8a66\u9a57\u6578\u64da\u7684\u4f7f\u7528\u61c9\u9650\u65bc\u5728\u76f8\u5c0d\u57fa\u790e\u4e0a\u5c0d\u6750\u6599\u7684\u7a81\u7834\u6642\u9593\u9032\u884c\u6bd4\u8f03\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u79a6\u523a\u6fc0\u6027\u5316\u5b78\u54c1\u7684\u4fdd\u8b77\u6027\u624b\u5957\uff08\u6d78\u6ce1\u4fdd\u8b77\uff09\u3002<\/p>\n<p>*\u8a72\u6a19\u6e96\u5df2\u65bc2015\u5e742\u670818\u65e5\u64a4\u92b7\uff0c\u96a8\u5f8c\u88ab<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:67114&amp;cs=12111366893D822A8C42FADA2EB30992C\" target=\"_blank\" rel=\"noopener\">EN 16523-1:2015<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 421:2010 \u9632\u6b62\u96fb\u96e2\u8f3b\u5c04\u548c\u653e\u5c04\u6027\u6c61\u67d3\u7684\u9632\u8b77\u624b\u5957<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u6b62\u96fb\u96e2\u8f3b\u5c04\u548c\u653e\u5c04\u6027\u6c61\u67d3\u7684\u624b\u5957\u7684\u8981\u6c42\u548c\u8a66\u9a57\u65b9\u6cd5\u3002\u8a72\u6a19\u6e96\u9069\u7528\u65bc\u70ba\u624b\u548c\u624b\u81c2\u53ca\u80a9\u90e8\u5404\u90e8\u4f4d\u63d0\u4f9b\u4fdd\u8b77\u7684\u624b\u5957\u3002\u5b83\u4e5f\u9069\u7528\u65bc\u5b89\u88dd\u5728\u6c38\u4e45\u9632\u8b77\u7f69\u5167\u7684\u624b\u5957\u3002\u672c\u6b50\u6d32\u6a19\u6e96\u4e5f\u9069\u7528\u65bc\u5728\u624b\u5957\u548c\u6c38\u4e45\u9632\u8b77\u7f69\u4e4b\u9593\u4f7f\u7528\u7684\u4e2d\u9593\u5957\u7b52\u3002\u672c\u6b50\u6d32\u6a19\u6e96\u7684\u8981\u6c42\u4e0d\u9069\u7528\u65bc\u9632\u6b62X\u5c04\u7dda\u8f3b\u5c04\u7684\u9632\u8b77\u624b\u5957\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u6b62\u653e\u5c04\u6027\u7c92\u5b50\u6c61\u67d3\u7684\u9632\u8b77\u624b\u5957\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 1149-5 \u9632\u8b77\u670d &#8211; \u975c\u96fb\u7279\u6027 &#8211; \u7b2c5\u90e8\u5206\uff1a\u6750\u6599\u6027\u80fd\u548c\u8a2d\u8a08\u8981\u6c42<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u975c\u96fb\u8017\u6563\u9632\u8b77\u670d\uff08\u5305\u62ec\u982d\u7f69\u548c\u5e3d\u5b50\uff09\u7684\u6750\u6599\u548c\u8a2d\u8a08\u8981\u6c42\uff0c\u4f5c\u70ba\u6574\u9ad4\u63a5\u5730\u7cfb\u7d71\u7684\u4e00\u90e8\u5206\u4f7f\u7528\uff0c\u4ee5\u907f\u514d\u5728\u7206\u70b8\u6027\u74b0\u5883\u7684\u6700\u5c0f\u9ede\u706b\u80fd\u91cf\u4e0d\u4f4e\u65bc0.016mJ\u7684\u60c5\u6cc1\u4e0b\u767c\u751f\u71c3\u71d2\u6027\u653e\u96fb\u3002\u6750\u6599\u548c\u8a2d\u8a08\u8981\u6c42\u4e26\u4e0d\u5047\u5b9a\u7a7f\u6234\u6216\u651c\u5e36\u7684\u8207\u8863\u670d\u63a5\u89f8\u7684\u984d\u5916\u8a2d\u5099\uff0c\u5982\u547c\u5438\u5668\u7b49\u6709\u8db3\u5920\u7684\u63a5\u5730\u3002\u5982\u679c\u9019\u4e9b\u9644\u52a0\u8a2d\u5099\u9700\u8981\u63a5\u5730\uff0c\u53ef\u80fd\u9700\u8981\u672c\u6b50\u6d32\u6a19\u6e96\u7bc4\u570d\u4ee5\u5916\u7684\u5176\u4ed6\u8981\u6c42\u3002\u672c\u6a19\u6e96\u7684\u7bc4\u570d\u4e0d\u5305\u62ec\u55ae\u7368\u7684\u800c\u4e0d\u662f\u670d\u88dd\u7684\u7d44\u6210\u90e8\u5206\u7684\u975c\u96fb\u6d88\u6563\u4fdd\u8b77\u624b\u5957\u6216\u978b\u985e\u3002\u672c\u6a19\u6e96\u4e0d\u9069\u7528\u65bc\u5c0d\u96fb\u6e90\u96fb\u58d3\u7684\u4fdd\u8b77\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u5982\u679cPPE\u7b2c\u4e09\u985e\u4e00\u6b21\u6027\u624b\u5957\u7d93\u904eEN1149-1:2006\u6216EN1149-3:2004\u7684\u6e2c\u8a66\uff0c\u4e26\u6eff\u8db3\u81f3\u5c11\u4e00\u500b\u8981\u6c42\u7684\u6c34\u5e73\uff0c\u5c31\u53ef\u4ee5\u9032\u884c\u6297\u975c\u96fb\u8072\u660e\uff1a\uff081\uff09\u8868\u9762\u96fb\u963b\uff08EN1149-1:2006\uff09\u5fc5\u9808\u5c0f\u65bc5\u00d71010\u6b50\u59c6\uff1b\uff082\uff09\u611f\u61c9\u5145\u96fb\/\u975c\u96fb\u8870\u6e1b\uff08EN1149-3:2004\uff09\u534a\u8870\u671f&lt;4\u79d2\u6216\u5c4f\u853d\u4fc2\u6578&gt;0.2\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 388:2003 \u9632\u79a6\u6a5f\u68b0\u98a8\u96aa\u7684\u9632\u8b77\u624b\u5957<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u8b77\u624b\u5957\u7684\u8981\u6c42\u3001\u6e2c\u8a66\u65b9\u6cd5\u3001\u6a19\u8b58\u548c\u63d0\u4f9b\u7684\u8a13\u606f\uff0c\u4ee5\u9632\u6b62\u78e8\u640d\u3001\u5200\u7247\u5207\u5272\u3001\u6495\u88c2\u548c\u523a\u7a7f\u7684\u6a5f\u68b0\u98a8\u96aa\u3002\u672c\u6a19\u6e96\u50c5\u8207EN 420\u4e00\u8d77\u9069\u7528\u3002\u672c\u6a19\u6e96\u5236\u5b9a\u7684\u6e2c\u8a66\u65b9\u6cd5\u4e5f\u53ef\u9069\u7528\u65bc\u8207\u624b\u5957\u6216\u670d\u88dd\u5206\u958b\u7684\u4fdd\u8b77\u88dd\u7f6e&#8211;\u624b\u81c2\u4fdd\u8b77\u5668\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u6b62\u6a5f\u68b0\u98a8\u96aa\u7684\u9632\u8b77\u624b\u5957\u3002<\/p>\n<p>*\u8a72\u6a19\u6e96\u65bc2016\u5e7411\u67082\u65e5\u88ab\u64a4\u92b7\uff0c\u96a8\u5f8c\u88ab<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:68298&amp;cs=193BC6D124D9738219FC8585E0B2298AA\" target=\"_blank\" rel=\"noopener\">EN 388:2016<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 407:2004 \u9632\u6b62\u71b1\u98a8\u96aa\uff08\u71b1\u548c\/\u6216\u706b\uff09\u7684\u9632\u8b77\u624b\u5957<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u71b1\u548c\/\u6216\u9632\u706b\u7684\u9632\u8b77\u624b\u5957\u7684\u6e2c\u8a66\u65b9\u6cd5\u3001\u4e00\u822c\u8981\u6c42\u3001\u71b1\u6027\u80fd\u7b49\u7d1a\u548c\u6a19\u8b58\u3002\u672c\u6a19\u6e96\u9069\u7528\u65bc\u6240\u6709\u4fdd\u8b77\u624b\u90e8\u514d\u53d7\u4ee5\u4e0b\u4e00\u7a2e\u6216\u591a\u7a2e\u5f62\u5f0f\u7684\u71b1\u548c\/\u6216\u706b\u7130\u5f71\u97ff\u7684\u624b\u5957\uff1a\u706b\u3001\u63a5\u89f8\u71b1\u3001\u5c0d\u6d41\u71b1\u3001\u8f3b\u5c04\u71b1\u3001\u5c0f\u7bc4\u570d\u98db\u6ffa\u6216\u5927\u91cf\u7194\u878d\u91d1\u5c6c\u3002\u9084\u6709\u4e00\u4e9b\u8207\u5177\u9ad4\u61c9\u7528\u76f8\u95dc\u7684\u6a19\u6e96\uff0c\u4f8b\u5982\u6d88\u9632\u6216\u710a\u63a5\u3002\u7522\u54c1\u6e2c\u8a66\u53ef\u80fd\u53ea\u7d66\u51fa\u6027\u80fd\u7b49\u7d1a\u800c\u4e0d\u662f\u4fdd\u8b77\u7b49\u7d1a\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u6b62\u71b1\u98a8\u96aa\uff08\u71b1\u548c\/\u6216\u706b\u707d\uff09\u7684\u9632\u8b77\u624b\u5957\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>*\u8a72\u6a19\u6e96\u5df2\u65bc2020\u5e744\u67088\u65e5\u64a4\u92b7\uff0c\u7531<a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT:68298&amp;cs=193BC6D124D9738219FC8585E0B2298AA\" target=\"_blank\" rel=\"noopener\">EN 407:2020<\/a>\u53d6\u4ee3\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>EN 511:2006 \u9632\u5bd2\u4fdd\u8b77\u624b\u5957<\/h3>\n<p>\u672c\u6a19\u6e96\u898f\u5b9a\u4e86\u9632\u8b77\u4f4e\u81f3-50\u2103\u7684\u5c0d\u6d41\u548c\u50b3\u5c0e\u6027\u5bd2\u51b7\u7684\u624b\u5957\u7684\u8981\u6c42\u548c\u6e2c\u8a66\u65b9\u6cd5\u3002\u9019\u7a2e\u5bd2\u51b7\u53ef\u80fd\u8207\u6c23\u5019\u689d\u4ef6\u6216\u5de5\u696d\u6d3b\u52d5\u6709\u95dc\u3002\u4e0d\u540c\u6027\u80fd\u7b49\u7d1a\u7684\u5177\u9ad4\u6578\u503c\u7531\u6bcf\u4e00\u985e\u98a8\u96aa\u7684\u7279\u6b8a\u8981\u6c42\u6216\u7279\u6b8a\u61c9\u7528\u9818\u57df\u6c7a\u5b9a\u3002\u7522\u54c1\u6e2c\u8a66\u53ef\u80fd\u53ea\u7d66\u51fa\u6027\u80fd\u7b49\u7d1a\u800c\u4e0d\u662f\u4fdd\u8b77\u7b49\u7d1a\u3002<\/p>\n<h3>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/h3>\n<p>\u9632\u5bd2\u9632\u8b77\u624b\u5957\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>EN 455 \u4e00\u6b21\u6027\u4f7f\u7528\u7684\u91ab\u7528\u624b\u5957<\/strong><\/h3>\n<p>\u8a72\u6a19\u6e96\u898f\u5b9a\u4e86\u4efb\u4f55\u7528\u65bc\u91ab\u7642\u76ee\u7684\u7684\u624b\u5957\u7684\u8981\u6c42\u548c\u6e2c\u8a66\u65b9\u6cd5\u3002\u5b83\u6709\u56db\u500b\u90e8\u5206\uff1a<\/p>\n<ul>\n<li aria-level=\"1\"><a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:67691,6186&amp;cs=17D89DEFF4F7421FD167D17FB9F138C78\" target=\"_blank\" rel=\"noopener\">EN 455-1<\/a>: \u7121\u5b54\u8981\u6c42\u548c\u6e2c\u8a66<\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:35266,6186&amp;cs=1783B590224FD05CFAE5E92829123397F\" target=\"_blank\" rel=\"noopener\">EN 455-2<\/a>: \u7269\u7406\u6027\u80fd\u8981\u6c42\u548c\u6e2c\u8a66<\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:37147,6186&amp;cs=1D96A506EB1F528793DF99D047800A953\" target=\"_blank\" rel=\"noopener\">EN 455-3<\/a>: \u751f\u7269\u5b78\u8a55\u50f9\u7684\u8981\u6c42\u548c\u6e2c\u8a66<\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/standards.cencenelec.eu\/dyn\/www\/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:26420,6186&amp;cs=19822CF5876BDDB1594CDF982A6442804\" target=\"_blank\" rel=\"noopener\">EN 455-4<\/a>: \u4fdd\u8cea\u671f\u6e2c\u5b9a\u7684\u8981\u6c42\u548c\u6e2c\u8a66<\/li>\n<\/ul>\n<p>\u9019\u4e9b\u884c\u696d\u6a19\u6e96\u7684\u5236\u5b9a\u662f\u70ba\u4e86\u78ba\u4fdd\u5728\u91ab\u7642\u6aa2\u67e5\u548c\u6cbb\u7642\u904e\u7a0b\u4e2d\u4f7f\u7528\u7684\u624b\u5957\u80fd\u5920\u9632\u6b62\u91ab\u8b77\u4eba\u54e1\u7684\u624b\u53d7\u5230\u6c61\u67d3\uff0c\u6e1b\u5c11\u75c5\u539f\u9ad4\u6216\u5176\u4ed6\u6709\u5bb3\u7269\u8cea\u7684\u50b3\u64ad\u3002<\/p>\n<p><strong>\u9700\u8981\u4ec0\u9ebc\u985e\u578b\u7684\u624b\u5957\uff1f<\/strong><\/p>\n<p>\u4efb\u4f55\u53ef\u7528\u65bc\u91ab\u7642\u4efb\u52d9\u7684\u624b\u5957\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>\u5fae\u751f\u7269\u98a8\u96aa\u8207\u91ab\u7528\u624b\u5957<\/h2>\n<p>\u4e00\u822c\u4f86\u8aaa\uff0c\u5fae\u751f\u7269\u8d8a\u5c0f\uff0c\u901a\u904e\u624b\u5957\u7f3a\u9677\u7a7f\u900f\u7684\u98a8\u96aa\u5c31\u8d8a\u5927\u3002\u70ba\u4e86\u8a55\u4f30\u5fae\u751f\u7269\u7a7f\u900f\u9632\u8b77\u624b\u5957\u7684\u98a8\u96aa\uff0c\u901a\u5e38\u63a1\u7528EN 374-2\u6a19\u6e96\u3002<\/p>\n<p>EN374-2:2003\u898f\u5b9a\u4e86\u9632\u8b77\u5316\u5b78\u54c1\u548c\/\u6216\u5fae\u751f\u7269\u7684\u624b\u5957\u7684\u6297\u7a7f\u900f\u6027\u7684\u6e2c\u8a66\u65b9\u6cd5\u3002\u5728\u8a72\u6a19\u6e96\u767c\u4f48\u6642\uff0c\u4eba\u5011\u8a8d\u70ba\uff0c\u6309\u7167EN374\u6a19\u6e96\u6e2c\u8a66\uff0c\u6297\u7a7f\u900f\u6027\u5f37\u7684\u624b\u5957\u5c07\u5f62\u6210\u5c0d\u5fae\u751f\u7269\u5371\u5bb3\u7684\u6709\u6548\u5c4f\u969c\u3002<\/p>\n<p>\u9664EN374-2\u6e2c\u8a66\u6a19\u6e96\u5916\uff0cISO 16604:2004\u548cASTM F1671-97b\uff08\u4ee5Phi-X174\u566c\u83cc\u9ad4\u6ef2\u900f\u70ba\u6e2c\u8a66\u7cfb\u7d71\u7684\u9632\u8b77\u670d\u6750\u6599\u62b5\u6297\u8840\u6e90\u6027\u75c5\u539f\u9ad4\u6ef2\u900f\u7684\u6a19\u6e96\u6e2c\u8a66\u65b9\u6cd5\uff09\u662f\u5168\u7403\u516c\u8a8d\u7684\u5c08\u9580\u7528\u65bc\u8a55\u4f30\u624b\u5957\u62b5\u6297\u75c5\u6bd2\u6ef2\u900f\u7684\u6e2c\u8a66\u6a19\u6e96\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>\u60a8\u6700\u9069\u5408\u8cfc\u8cb7\u54ea\u7a2e\u985e\u578b\u7684\u624b\u5957\uff1f<\/h2>\n<p>\u60a8\u9078\u64c7\u7684\u624b\u5957\u5c07\u53d6\u6c7a\u65bc\u8981\u57f7\u884c\u7684\u4efb\u52d9\u7684\u6027\u8cea\uff08\u662f\u5426\u6703\u6709\u5371\u96aa\u7269\u8cea\u548c\u9019\u4e9b\u7269\u8cea\u7684\u5316\u5b78\u7279\u6027\uff09\u3002\u9019\u4e5f\u5c07\u53d6\u6c7a\u65bc\u8207\u6709\u5bb3\u7269\u8cea\u63a5\u89f8\u7684\u6027\u8cea\uff08\u662f\u5426\u9577\u6642\u9593\u3001\u9593\u6b47\u6027\u3001\u5b8c\u5168\u6216\u90e8\u5206\u6d78\u5165\uff09\u3002\u6b64\u5916\uff0c\u9078\u64c7\u5177\u6709\u9069\u7576\u7d1a\u5225CE\u8a8d\u8b49\u7684\u624b\u5957\u4e5f\u5f88\u91cd\u8981\u3002<\/p>\n<p>\u9032\u4e00\u6b65\u95b1\u8b80\uff1a<a href=\"\/zh-hant\/?p=8636\">\u4e01\u8148\u624b\u5957\u3001\u4e73\u81a0\u624b\u5957\u3001PVC\u624b\u5957 \u2013 \u9019 3 \u7a2e\u624b\u5957\u985e\u578b\u6709\u4ec0\u9ebc\u5340\u5225\uff1f<\/a><\/p>\n<p>\u9078\u64c7\u6b63\u78ba\u624b\u5957\u7684\u5176\u4ed6\u8003\u616e\u56e0\u7d20\u5305\u62ec\uff1a<\/p>\n<ol>\n<li aria-level=\"1\">\u904e\u654f\u7684\u98a8\u96aa:\n<ol>\n<li aria-level=\"2\">\u8207\u4e73\u81a0\u76f8\u6bd4\uff0c\u4e01\u8148\u7b49\u5408\u6210\u6750\u6599\u5f15\u8d77\u7684\u904e\u654f\u53cd\u61c9\u8f03\u5c11<\/li>\n<li aria-level=\"2\">\u5316\u5b78\u4fc3\u9032\u5291\u5982\u567b\u5511\u3001\u79cb\u862d\u59c6\u548c\u4e8c\u786b\u4ee3\u6c28\u57fa\u7532\u9178\u9e7d\u662f\u5df2\u77e5\u7684\u53ef\u80fd\u5f15\u767c\u904e\u654f\u7684\u5316\u5b78\u8a66\u5291\uff1b \u56e0\u6b64\u4e0d\u542b\u4fc3\u9032\u5291\u7684\u7522\u54c1\u53ef\u80fd\u662f\u66f4\u597d\u7684\u9078\u64c7<\/li>\n<\/ol>\n<\/li>\n<li aria-level=\"1\">\u78ba\u4fdd\u8cfc\u8cb7\u5c3a\u5bf8\u6b63\u78ba\u3001\u5408\u8eab\u7684\u624b\u5957<\/li>\n<li aria-level=\"1\">\u6027\u80fd\u7279\u5fb5\uff0c\u4f8b\u5982\u6293\u5730\u529b\u3001\u9577\u5ea6\u3001\u9748\u6d3b\u6027\u3001\u8212\u9069\u5ea6\u548c\u7d55\u7de3\u6027<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h2>\u7d50\u8ad6<\/h2>\n<p>\u81ea COVID-19 \u5927\u6d41\u884c\u958b\u59cb\u4ee5\u4f86\uff0c\u6709\u5927\u91cf\u95dc\u65bc\u507d\u9020\u6216\u4e0d\u5408\u683c\u91ab\u7642\u7522\u54c1\uff08\u5305\u62ec\u91ab\u7528\u624b\u5957\uff09\u7684\u5831\u5c0e\u3002 \u7531\u65bc\u91ab\u7528\u624b\u5957\u662f\u91ab\u8b77\u4eba\u54e1\u7684\u624b\u8207\u60a3\u8005\u9ad4\u6db2\uff08\u4f8b\u5982\u8840\u6db2\u3001\u547c\u5438\u9053\u5206\u6ccc\u7269\u3001\u5614\u5410\u7269\u3001\u5c3f\u6db2\u6216\u7cde\u4fbf\uff09\u3001\u67d0\u4e9b\u5371\u96aa\u85e5\u7269\u6216\u67d0\u4e9b\u6f5b\u5728\u6c61\u67d3\u7269\u54c1\u4e4b\u9593\u7684\u7b2c\u4e00\u9053\u9632\u7dda\uff0c\u56e0\u6b64\u91ab\u7642\u624b\u5957\u7684\u8cea\u91cf \u624b\u5957\u7684\u91cd\u8981\u6027\u600e\u9ebc\u5f37\u8abf\u90fd\u4e0d\u70ba\u904e\u3002 \u5c0d\u6b64\uff0c\u53ea\u6709\u9ad8\u8cea\u91cf\u7684\u91ab\u7528\u624b\u5957\u624d\u80fd\u6709\u6548\u9632\u6b62\u91ab\u8b77\u4eba\u54e1\u96d9\u624b\u53d7\u5230\u6c61\u67d3\uff0c\u6e1b\u5c11\u75c5\u539f\u9ad4\u7684\u50b3\u64ad\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u70ba\u4e86\u7372\u5f97\u5408\u683c\u7684\u7522\u54c1\uff0c\u7e3d\u9ad4\u4e86\u89e3<a href=\"\/zh-hant\/oem-and-odm-service\/ppe\/\">\u91ab\u7528\u624b\u5957<\/a>\u7684\u8a8d\u8b49\u8981\u6c42\u975e\u5e38\u91cd\u8981\uff0c\u5305\u62ec\u4e0a\u9762\u8a0e\u8ad6\u7684FDA\u8981\u6c42\u3001CE\u6a19\u8a8c\u548cEN\u5de5\u696d\u6a19\u6e96\u3002<\/p>\n<p><i>\u00a0<\/i><\/p>\n<p>\u53c3\u8003\uff1a<\/p>\n<ol>\n<li>\u4e86\u89e3\u624b\u5957\u8a8d\u8b49\u3002 \uff08\u65e5\u671f\u4e0d\u8a73\uff09\u3002<a href=\"https:\/\/www.kcprofessional.com\/en-gb\" target=\"_blank\" rel=\"noopener\">Https:\/\/Www.Kcprofessional.Co.Uk\/.<\/a> <a href=\"https:\/\/www.kcprofessional.co.uk\/media\/54391844\/Glove%20Certification%20guide%20-%20from%20KIMTECH.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.kcprofessional.co.uk\/media\/54391844\/Glove%20Certification%20guide%20-%20from%20KIMTECH.pdf<\/a><\/li>\n<li><a href=\"https:\/\/www.scribbr.com\/taxonomy\/term\/814\" target=\"_blank\" rel=\"noopener\" hreflang=\"en\">Center for Devices and Radiological Health<\/a>. \uff08\u65e5\u671f\u4e0d\u8a73\uff09\u3002 COVID-19 \u91ab\u7528\u624b\u5957\u3002 \u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u7ba1\u7406\u5c40\u3002 \u6aa2\u7d22\u65bc 2021 \u5e74 9 \u6708 28 \u65e5\uff0c\u4f86\u81ea<a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/medical-gloves-covid-19\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/medical-gloves-covid-19<\/a><\/li>\n<li>CE \u6a19\u8a8c \u2013 \u7372\u5f97\u8b49\u66f8\u3001\u6b50\u76df\u8981\u6c42\u3002 \uff08\u65e5\u671f\u4e0d\u8a73\uff09\u3002 \u4f60\u7684\u6b50\u6d32\u3002 \u6aa2\u7d22\u65bc 2021 \u5e74 9 \u6708 28 \u65e5\uff0c\u4f86\u81ea <a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/labels-markings\/ce-marking\/index_en.htm\" target=\"_blank\" rel=\"noopener\">https:\/\/europa.eu\/youreurope\/business\/product-requirements\/labels-markings\/ce-marking\/index_en.htm<\/a><\/li>\n<li>\u624b\u5957\u4f7f\u7528\u8a0a\u606f\u55ae\u5f35\u3002 \uff08\u65e5\u671f\u4e0d\u8a73\uff09\u3002 WHO\u3002 <a href=\"https:\/\/www.who.int\/gpsc\/5may\/Glove_Use_Information_Leaflet.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.who.int\/gpsc\/5may\/Glove_Use_Information_Leaflet.pdf<\/a><\/li>\n<li>iTeh Standards \u2013 \u6a19\u6e96\u548c\u898f\u7bc4\u7684\u4f86\u6e90\u3002 \uff08\u65e5\u671f\u4e0d\u8a73\uff09\u3002 ITeh \u6a19\u6e96\u5546\u5e97\u3002 2021 \u5e74 9 \u6708 28 \u65e5\u6aa2\u7d22\u81ea <a href=\"https:\/\/standards.iteh.ai\/\" target=\"_blank\" rel=\"noopener\">https:\/\/standards.iteh.ai\/<\/a><\/li>\n<li><a href=\"https:\/\/www.scribbr.com\/taxonomy\/term\/814\" target=\"_blank\" rel=\"noopener\" hreflang=\"en\">Center for Devices and Radiological Health<\/a>. \uff082020 \u5e74 3 \u6708 30 \u65e5\uff09\u3002 \u51a0\u72c0\u75c5\u6bd2\u75c5 (COVID-19) \u7a81\u767c\u516c\u5171\u885b\u751f\u4e8b\u4ef6\u671f\u9593\u79ae\u670d\u3001\u5176\u4ed6\u670d\u88dd\u548c\u624b\u5957\u7684\u57f7\u884c\u653f\u7b56\u3002 \u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u7ba1\u7406\u5c40\u3002\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>\u91ab\u7528\u624b\u5957\u7684\u8a8d\u8b49\u8981\u6c42\u662f\u4ec0\u9ebc\uff1f FDA \u65bc 2020 \u5e74 3 \u6708\u767c\u5e03\u4e86\u6307\u5357\uff0c\u63d0\u4f9b\u4e86\u91ab\u7528\u624b\u5957\u7684\u8a73\u7d30\u653f\u7b56\u3002<\/p>\n","protected":false},"author":3,"featured_media":5732,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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