{"id":4465,"date":"2018-11-22T14:50:43","date_gmt":"2018-11-22T06:50:43","guid":{"rendered":"https:\/\/www.eamar.com.cn\/?p=4465"},"modified":"2018-11-22T14:50:43","modified_gmt":"2018-11-22T06:50:43","slug":"%e6%ac%a7%e7%9b%9f%e5%8f%91%e5%b8%83%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%95%e8%a7%84-mdr%ef%bc%8c%e4%bc%9f%e8%bf%aa%e6%8d%b7%e5%96%b7%e7%a0%81%e6%9c%ba%e7%8e%87%e5%85%88%e5%93%8d%e5%ba%94","status":"publish","type":"post","link":"https:\/\/www.eamar.com.cn\/archives\/4465","title":{"rendered":"\u6b27\u76df\u53d1\u5e03\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (MDR)\uff0c\u4f1f\u8fea\u6377\u55b7\u7801\u673a\u7387\u5148\u54cd\u5e94"},"content":{"rendered":"

\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4 2017\/745 \u5373\u5c06\u751f\u6548\uff0c\u8be5\u6cd5\u89c4\u5c06\u8981\u6c42\u5236\u9020\u5546\uff0c\u5728\u6b27\u76df\u5883\u5185\u5206\u9500\u7684\u533b\u7597\u5668\u68b0\u6807\u8bc6\u540d\u4e3a\u552f\u4e00\u5668\u68b0\u6807\u8bc6 (UDI)\u7279\u5b9a\u4ee3\u7801\u3002\uff082017\/745\u662f\u6b27\u76df\u7684\u6cd5\u89c4\u540d\u79f0\uff0c\u4e0d\u662f\u65e5\u671f\u54e6\uff09\u3002\u5bf9\u4e8e\u51fa\u53e3\u533b\u7597\u8bbe\u5907\u7684\u670b\u53cb\u4eec\u4e00\u5b9a\u8981\u4e86\u89e3UDI \u662f\u4ec0\u4e48\uff1f\u4e0d\u7136\uff0c\u4f1a\u5f71\u54cd\u60a8\u4e1a\u52a1\u53d1\u5c55\uff0c\u53ef\u80fd\u4e00\u4e0d\u5c0f\u5fc3\u5c31\u9519\u8fc7\u51e0\u4e2a\u4ebf.<\/p>\n

\u552f\u4e00\u533b\u7597\u5668\u68b0\u6807\u8bc6 (UDI) \u662f\u4e00\u5957\u7531\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u521b\u5efa\u548c\u7ba1\u7406\u7684\u552f\u4e00\u533b\u7597\u5668\u68b0\u6807\u8bc6\u7cfb\u7edf\u3002\u8be5\u7cfb\u7edf\u7684\u8bbe\u8ba1\u610f\u56fe\u662f\u5145\u5206\u8bc6\u522b\u5904\u4e8e\u5206\u9500\u548c\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u7684\u533b\u7597\u5668\u68b0\u3002\u5982\u8981\u5b8c\u5168\u5b9e\u73b0\u4e0a\u8ff0\u76ee\u7684\uff0c\u5927\u591a\u6570\u533b\u7597\u5668\u68b0\u4e0a\u9700\u5305\u542b\u4e00\u4e2a\u4eba\u5de5\u53ef\u8bfb\u548c\u673a\u5668\u53ef\u8bfb\u7684\u552f\u4e00\u533b\u7597\u5668\u68b0\u6807\u8bc6\u7b26\u3002\u5982\u679c\u9700\u8981\uff0c\u4e0d\u53ea\u5e94\u5728\u5176\u6807\u7b7e\u548c\u5305\u88c5\u4e0a\uff0c\u8fd8\u5e94\u5728\u5668\u68b0\u672c\u4f53\u4e0a\u6807\u8bc6\u8fd9\u4e9b\u6807\u8bc6\u7b26\u3002<\/p>\n

\u63a5\u4e0b\u6765\u4f60\u53ef\u80fd\u4f1a\u95ee\uff0c\u4ec0\u4e48\u662f\u533b\u7597\u5668\u68b0\uff0c\u4e0d\u540c\u7684\u533b\u7597\u5668\u68b0\u7c7b\u578b\u5904\u4e8e\u4f55\u79cd\u7b49\u7ea7\uff1f<\/p>\n

\u793a\u4f8b\u5982\u4e0b\uff1a<\/p>\n

\"\"\"\"
\u6bcf\u53f0\u533b\u7597\u5668\u68b0\u4e0a\uff0c\u6807\u7b7e\u548c\u5305\u88c5\u5fc5\u987b\u7b26\u5408\u6cd5\u5f8b\u89c4\u5b9a\uff0c\u5668\u68b0\u4e0a\u5fc5\u987b\u6709\u4eba\u5de5\u53ef\u8bfb\uff08\u7eaf\u6587\u672c\uff09\u7684 UDI\u7801\uff0c\u8fd8\u5fc5\u987b\u4f7f\u7528\u81ea\u52a8\u8bc6\u522b\u4e0e\u6570\u636e\u91c7\u96c6 (AIDC) \u6280\u672f\u4f7f\u673a\u5668\u53ef\u8bfb\u3002<\/p>\n

\u76ee\u524dUDI \u7f16\u7801\u53ea\u5f71\u54cd\u533b\u7597\u5668\u68b0\u7c7b\u8fdb\u51fa\u53e3\u884c\u4e1a\uff0c\u672a\u6765\u5728\u4e2d\u56fd\u662f\u5426\u4f1a\u5f71\u54cd\u6240\u6709\u533b\u7597\u5668\u68b0\u884c\u4e1a\uff0c\u6211\u56fd\u4e5f\u5728\u5236\u4f5c \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u7cfb\u7edf\u89c4\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f \uff09\u5728\u4e0d\u8fdc\u7684\u672a\u6765\uff0c\u4e5f\u662f\u4e00\u5927\u8d8b\u52bf\u3002<\/p>\n

\"\"
Videojet \u63d0\u4f9b\u4e00\u7cfb\u5217\u7b26\u5408 UDI \u6cd5\u6848\u7684\u89e3\u51b3\u65b9\u6848\u3002Videojet Wolke \u7cfb\u5217\u55b7\u58a8\u55b7\u7801\u673a<\/a><\/span>\u5728\u8fc7\u53bb\u5341\u591a\u5e74\u4e00\u76f4\u662f\u5728\u533b\u7597\u5668\u68b0\u5305\u88c5\u4e0a\u63d0\u4f9b\u4f18\u8d28\u7f16\u7801\u55b7\u5370\u7684\u6807\u51c6\u89e3\u51b3\u65b9\u6848\u3002\u6b64\u5916\uff0cVideojet \u7684\u70ed\u53d1\u6ce1\u55b7\u58a8 (TIJ) \u55b7\u7801\u673a\u5728\u5236\u836f\u884c\u4e1a\u62e5\u6709\u5168\u7403\u5f88\u5927\u7684\u88c5\u673a\u91cf\u3002Videojet TIJ \u55b7\u7801\u673a\u53ef\u5728\u533b\u7597\u5668\u68b0\u5305\u88c5\u4e0a\u55b7\u5370\u7b26\u5408 GS1 \u6807\u51c6\u4ee5\u53ca UDI \u6cd5\u89c4\u7684\u6761\u7801\u3002<\/p>\n

\u96c6\u6210\u5230\u70ed\u6210\u578b\u673a<\/p>\n

Videojet TIJ \u5728\u8bbe\u8ba1\u65f6\u878d\u5165\u4e86\u96c6\u6210\u7406\u5ff5\uff0c\u8fd9\u5df2\u4ece\u5927\u91cf\u7ecf\u8fc7\u6d4b\u8bd5\u7684\u70ed\u6210\u578b\u5305\u88c5\u8bbe\u5907\u96c6\u6210\u4e2d\u5f97\u5230\u8bc1\u660e\u3002\u7406\u60f3\u7684\u60c5\u51b5\u4e0b\uff0c\u55b7\u7801\u673a\u5e94\u7f6e\u4e8e\u5c01\u76d6\u5377\u7b52\u7eb8\u88ab\u70ed\u5bc6\u5c01\u4e4b\u524d\u7684\u4f4d\u7f6e\u3002\u4f1f\u8fea\u6377\u55b7\u7801\u673a<\/a><\/span>\u7684\u7d27\u51d1\u8bbe\u8ba1\u4f7f\u4e4b\u53ef\u4ee5\u653e\u7f6e\u5728\u5927\u591a\u6570\u5305\u88c5\u8bbe\u5907\u901a\u5e38\u7559\u51fa\u7684\u72ed\u5c0f\u7a7a\u95f4\u4e2d\u3002\u4e00\u79cd\u5e38\u89c1\u7684\u65b9\u6cd5\u662f\u8ba9\u55b7\u5934\u6cbf\u5377\u7b52\u7eb8\u6a2a\u5411\u79fb\u52a8\uff0c\u8fd9\u6837\u5728\u9a7b\u7559\u671f\u95f4\uff08\u5377\u7b52\u7eb8\u5728\u673a\u5668\u79fb\u52a8\u95f4\u9699\u5904\u4e8e\u9759\u6b62\u72b6\u6001\uff09\u53ef\u4ee5\u5355\u7a0b\u4e3a\u591a\u4e2a\u4ea7\u54c1\u55b7\u7801\u3002\u8be5\u89e3\u51b3\u65b9\u6848\u53ef\u9a71\u52a8\u591a\u8fbe\u56db\u4e2a\u72ec\u7acb\u7684\u9ad8\u901f\u55b7\u5934\uff0c\u5bf9\u5404\u6392\u4ea7\u54c1\u8fdb\u884c\u5747\u5300\u6392\u5217\u55b7\u7801\uff0c\u53ef\u6ee1\u8db3\u79fb\u52a8\u901f\u7387\u8981\u6c42\uff0c\u800c\u4e0d\u4f1a\u964d\u4f4e\u751f\u4ea7\u7387\u3002<\/p>\n

\u4f1f\u8fea\u6377\u55b7\u7801\u673a\u89e3\u51b3\u65b9\u6848\u7684\u4f18\u70b9<\/p>\n

Wolke TIJ \u6280\u672f\u6781\u4e3a\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\uff08\u5982\u533b\u7597\u7ea7\u900f\u6790\u7eb8\u6216DuPontTM 1059B\u548c1073B Tyvek\u00ae\uff09\u7684\u5e38\u7528\u5c01\u76d6\u57fa\u6750\u3002\u6b64\u5916\uff0cWolke\u7528\u6237\u754c\u9762\u63d0\u4f9b\u4f17\u591a\u8fde\u63a5\u9009\u9879\uff0c\u652f\u6301\u6765\u81ea\u5916\u90e8\u6570\u636e\u5e93\u4ee5\u53ca\u624b\u6301\u6761\u7801\u626b\u63cf\u4eea\u7684\u4f5c\u4e1a\u4fe1\u606f\u3002TIJ \u55b7\u7801\u673a\u80fd\u591f\u9ad8\u901f\u55b7\u7801\uff0c\u65e0\u9700\u727a\u7272\u55b7\u7801\u5206\u8fa8\u7387\u3002\u8be5\u6b3e\u55b7\u7801\u673a\u53ef\u4ee5\u5728\u4e0d\u523015 \u79d2\u949f\u7684\u65f6\u95f4\u5185\u5feb\u901f\u8f7b\u677e\u66f4\u6362\u58a8\u76d2\uff0c\u5e76\u4e14\u53ea\u9700\u7b80\u5355\u64e6\u62ed\u58a8\u76d2\u55b7\u5370\u9635\u5217\u548c\u55b7\u5934\u5373\u53ef\u5b9e\u73b0\u7ef4\u62a4\u8981\u6c42\uff0c\u4ece\u800c\u53ef\u63d0\u4f9b\u65e0\u53ef\u4f26\u6bd4\u7684\u7b80\u6613\u6027\u3002\u6bcf\u6b21\u66f4\u6362\u58a8\u76d2\u540e\uff0c\u55b7\u5370\u9635\u5217\u90fd\u4f1a\u7115\u7136\u4e00\u65b0\uff0c\u8fd9\u6709\u52a9\u4e8e\u786e\u4fdd\u6700\u4f73\u6027\u80fd\uff0c\u4ece\u800c\u6700\u5927\u9650\u5ea6\u5730\u5ef6\u957f\u6b63\u5e38\u8fd0\u884c\u65f6\u95f4\u3002\u65e0\u9700\u66f4\u6362\u6613\u635f\u4ef6\u6216\u7ef4\u62a4\u8017\u6750\uff0c\u4e5f\u65e0\u9700\u6821\u51c6\u7a0b\u5e8f\uff0c\u8fd9\u6709\u52a9\u4e8e\u51cf\u5c11\u8bbe\u7f6e\u4ee5\u53ca\u7ef4\u62a4\u65f6\u95f4\u3002<\/p>\n

\"\"<\/p>\n

\u9488\u5bf9\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u4f1f\u8fea\u6377\u55b7\u7801\u673a\u4e0a\u7ebf\u4e00\u6b3e\u533b\u836fAPP<\/p>\n

\u901a\u8fc7Videojet Pharma Line App\uff0c\u60a8\u53ef\u4ee5\u4e86\u89e3\u5230\u5404\u7c7b\u7528\u4e8e\u5178\u578b\u836f\u54c1\u5305\u88c5\u7684\u6807\u7b7e\u89e3\u51b3\u65b9\u6848\uff0c\u4ee5\u53ca\u7279\u5b9a\u5e94\u7528\u7a0b\u5e8f\u7684\u4fe1\u606f\uff0c\u5982\u6848\u4f8b\u7814\u7a76\u3001\u767d\u76ae\u4e66\u3001\u5c0f\u518c\u5b50\u548c\u89c6\u9891\u3002(\u8bf7\u5728iPhone app store \u641c\u7d22 videojet pharma line\uff0c\u76ee\u524d\u53ea\u652f\u6301 iphone\u4e0b\u8f7d)<\/p>\n

\"\"<\/p>\n

\u7ed3\u8bba<\/p>\n

\u51c6\u5907\u597d\u751f\u4ea7\u7ebf\u548c\u8bbe\u5907\u8fdb\u884c UDI \u55b7\u7801\u9700\u8981\u7f1c\u5bc6\u7684\u89c4\u5212\uff0c\u4f1f\u8fea\u6377\u53ef\u4ee5\u5e2e\u52a9\u60a8\u786e\u5b9a\u60a8\u7684\u751f\u4ea7\u7ebf\u9002\u7528\u7684\u7406\u60f3\u89e3\u51b3\u65b9\u6848\u3002\u4f1f\u8fea\u6377\u55b7\u7801\u673a\u4e0e\u591a\u5bb6\u91cd\u8981 OEM \u5bc6\u5207\u5408\u4f5c\uff0c\u6709\u52a9\u4e8e\u786e\u4fdd\u6211\u4eec\u7684\u6253\u7801\u673a\u65e0\u7f1d\u96c6\u6210\u5230\u60a8\u73b0\u6709\u7684\u5305\u88c5\u7ebf\uff0c\u5e76\u786e\u4fdd\u60a8\u7684 UDI \u55b7\u7801\u6d41\u7a0b\u5b8c\u7f8e\u5339\u914d\u60a8\u7684\u4e1a\u52a1\u9700\u6c42\u3002<\/p>\n

\"\"<\/p>\n

Videojet Technologies \u670d\u52a1\u4e8e\u5168\u7403\u4ea7\u54c1\u6807\u8bc6\u5e02\u573a\uff0c\u63d0\u4f9b\u5728\u7ebf\u55b7\u5370\u3001\u6253\u5370\u7b49\u4ea7\u54c1\u6807\u8bc6\u65b9\u6848\u3001\u4e0d\u540c\u5e94\u7528\u7684\u58a8\u6c34\/\u6eb6\u5242\u4ee5\u53ca\u4ea7\u54c1 LifeCycle Advantage TM\u884c\u7ef4\u62a4\u670d\u52a1\u3002\u6211\u4eec\u7684\u76ee\u6807\u662f\uff1a\u4e0e\u6d88\u8d39\u54c1\u5305\u88c5\u3001\u5236\u836f\u548c\u5de5\u4e1a\u4ea7\u54c1\u7b49\u884c\u4e1a\u7684\u5ba2\u6237\u5408\u4f5c\uff0c\u63d0\u9ad8\u751f\u4ea7\u7387\u3001\u4fdd\u62a4\u5e76\u4fc3\u8fdb\u5ba2\u6237\u54c1\u724c\u53d1\u5c55\uff0c\u8ba9\u5ba2\u6237\u59cb\u7ec8\u7ad9\u5728\u884c\u4e1a\u8d8b\u52bf\u548c\u6cd5\u89c4\u7684\u524d\u6cbf\u3002\u4f1f\u8fea\u6377\u5728\u5c0f\u5b57\u7b26\u55b7\u7801 (CIJ)\u3001\u70ed\u53d1\u6ce1\u55b7\u7801 (TIJ)\u3001\u6fc0\u5149\u6807\u8bc6\u3001\u70ed\u8f6c\u5370\u6253\u5370 (TTO)\u3001\u8d27\u7bb1\u6253\u5370\u8d34\u6807\u4ee5\u53ca\u5bbd\u9635\u5217\u6253\u5370\u7b49\u9886\u57df\uff0c\u62e5\u6709\u4f17\u591a\u5ba2\u6237\u5e94\u7528\u4e13\u5bb6\u548c\u591a\u9879\u6807\u8bc6\u6280\u672f\u3002\u622a\u6b62\u76ee\u524d\uff0c\u4f1f\u8fea\u6377\u5728\u5168\u7403\u7684\u88c5\u673a\u91cf\u5df2\u8d85\u8fc7 34.5 \u4e07\u53f0\u3002<\/p>\n

\"\"<\/p>\n

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