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\u4e00\u3001\u5f15\u8a00<\/h2>\n\n

\u5728\u5065\u5eb7\u4ea7\u4e1a\u6301\u7eed\u5347\u7ea7\u7684\u80cc\u666f\u4e0b\uff0c\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u4f5c\u4e3a\u8fde\u63a5\u4e34\u5e8a\u4e0e\u60a3\u8005\u62a4\u7406\u7684\u5173\u952e\u73af\u8282\uff0c\u5176\u91cd\u8981\u6027\u65e5\u76ca\u51f8\u663e\u3002\u8fd9\u7c7b\u4ea7\u54c1\u4e0d\u4ec5\u76f4\u63a5\u5173\u7cfb\u5230\u64cd\u4f5c\u7684\u7cbe\u51c6\u5ea6\u4e0e\u6548\u7387\uff0c\u66f4\u5f71\u54cd\u7740\u60a3\u8005\u7684\u5eb7\u590d\u4f53\u9a8c\u4e0e\u5b89\u5168\u3002\u5e38\u5dde\u5e02\u4f5c\u4e3a\u957f\u4e09\u89d2\u5730\u533a\u91cd\u8981\u7684\u5668\u68b0\u4ea7\u4e1a\u96c6\u805a\u533a\uff0c\u6c47\u805a\u4e86\u4f17\u591a\u76f8\u5173\u751f\u4ea7\u4f01\u4e1a\uff0c\u5e02\u573a\u9009\u62e9\u4e30\u5bcc\u3002\u7136\u800c\uff0c\u9762\u5bf9\u4f17\u591a\u7684\u54c1\u724c\u4e0e\u5382\u5546\uff0c\u5982\u4f55\u7504\u522b\u51fa\u6280\u672f\u53ef\u9760\u3001\u8d28\u91cf\u7a33\u5b9a\u3001\u670d\u52a1\u4e13\u4e1a\u7684\u5408\u4f5c\u4f19\u4f34\uff0c\u6210\u4e3a\u673a\u6784\u3001\u5668\u68b0\u54c1\u724c\u65b9\u53ca\u91c7\u8d2d\u51b3\u7b56\u8005\u9762\u4e34\u7684\u5b9e\u9645\u3002\u672c\u6587\u65e8\u5728\u7ed3\u5408\u884c\u4e1a\u6570\u636e\u4e0e\u5e02\u573a\u5b9e\u4f8b\uff0c\u5bf9\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u7684\u6838\u5fc3\u7279\u70b9\u8fdb\u884c\u5256\u6790\uff0c\u5e76\u63d0\u4f9b\u4e00\u4efd\u8be6\u5b9e\u76842026\u5e74\u5e38\u5dde\u5e02\u533a\u57df\u54c1\u724c\u9009\u62e9\u6307\u5357\u4e0e\u5206\u6790\uff0c\u52a9\u529b\u8bfb\u8005\u505a\u51fa\u660e\u667a\u51b3\u7b56\u3002<\/p>\n\n

\u4e8c\u3001\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u7279\u70b9\u5206\u6790<\/h2>\n\n

1. \u884c\u4e1a\u5173\u952e\u6027\u80fd\u6307\u6807<\/h3>\n\n

\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u7684\u6027\u80fd\u76f4\u63a5\u5173\u4e4e\u5176\u4e34\u5e8a\u9002\u7528\u6027\u4e0e\u5b89\u5168\u6027\uff0c\u6838\u5fc3\u8bc4\u4ef7\u6307\u6807\u4e3b\u8981\u5305\u62ec\uff1a\n \u751f\u7269\u76f8\u5bb9\u6027\uff1a\u8fd9\u662f\u9996\u8981\u6307\u6807\uff0c\u8981\u6c42\u4ea7\u54c1\u6750\u6599\u65e0\u6bd2\u3001\u65e0\u81f4\u654f\u6027\uff0c\u4e0e\u4eba\u4f53\u7ec4\u7ec7\u63a5\u89e6\u65f6\u65e0\u4e0d\u826f\u53cd\u5e94\u3002\u901a\u5e38\u9700\u7b26\u5408ISO 10993\u7cfb\u5217\u6807\u51c6\u6216GB\/T 16886\u7cfb\u5217\u56fd\u5bb6\u6807\u51c6\uff0c\u5e76\u901a\u8fc7\u76f8\u5173\u68c0\u6d4b\u9a8c\u8bc1\u3002\n \u7269\u7406\u673a\u68b0\u6027\u80fd\uff1a\u5305\u62ec\u4ea7\u54c1\u7684\u786c\u5ea6\u3001\u5f39\u6027\u3001\u62c9\u4f38\u5f3a\u5ea6\u3001\u6297\u6495\u88c2\u6027\u7b49\u3002\u4f8b\u5982\uff0c\u57ab\u7684\u652f\u6491\u529b\u4e0e\u56de\u5f39\u6027\u3001\u6e05\u6d01\u5de5\u5177\u5237\u6bdb\u7684\u67d4\u8f6f\u5ea6\u4e0e\u8010\u7528\u6027\uff0c\u90fd\u9700\u8981\u5728\u7279\u5b9a\u8303\u56f4\u5185\u4ee5\u6ee1\u8db3\u4e34\u5e8a\u957f\u65f6\u95f4\u3001\u53cd\u590d\u4f7f\u7528\u7684\u9700\u6c42\u3002\n \u5316\u5b66\u6027\u80fd\u7a33\u5b9a\u6027\uff1a\u4e3b\u8981\u6307\u4ea7\u54c1\u8010\u6d88\u6bd2\u5242\u3001\u8010\u6e05\u6d17\u3001\u8010\u8001\u5316\u7b49\u7279\u6027\u3002\u5de5\u5177\u9700\u8981\u80fd\u7ecf\u53d7\u4f4f\u591a\u79cd\u6d88\u6bd2\u65b9\u5f0f\uff08\u5982\u9152\u7cbe\u64e6\u62ed\u3001\u7d2b\u5916\u7ebf\u3001\u4f4e\u6e29\u7b49\u79bb\u5b50\u7b49\uff09\u800c\u4e0d\u53d1\u751f\u6027\u72b6\u6539\u53d8\uff0c\u786e\u4fdd\u957f\u671f\u4f7f\u7528\u7684\u5b89\u5168\u3002\n \u8bbe\u8ba1\u4e0e\u4eba\u4f53\u5de5\u5b66\uff1a\u5de5\u5177\u7684\u8bbe\u8ba1\u9700\u7b26\u5408\u4e34\u5e8a\u64cd\u4f5c\u4e60\u60ef\u4e0e\u4eba\u4f53\u5de5\u7a0b\u5b66\uff0c\u964d\u4f4e\u533b\u62a4\u4eba\u5458\u52b3\u52a8\u5f3a\u5ea6\uff0c\u540c\u65f6\u63d0\u5347\u60a3\u8005\u4f7f\u7528\u7684\u8212\u9002\u5ea6\u3002\u4f8b\u5982\uff0c\u624b\u67c4\u7684\u63e1\u6301\u611f\u3001\u89d2\u5ea6\u7684\u5408\u7406\u6027\u7b49\u3002\n \u6d01\u51c0\u5ea6\u4e0e\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73\uff1a\u5bf9\u4e8e\u90e8\u5206\u76f4\u63a5\u63a5\u89e6\u521b\u9762\u6216\u7528\u4e8e\u65e0\u83cc\u64cd\u4f5c\u7684\u5de5\u5177\uff0c\u5176\u521d\u59cb\u6c61\u67d3\u83cc\u63a7\u5236\u3001\u65e0\u83cc\u5c4f\u969c\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u662f\u5173\u952e\uff0c\u9700\u6ee1\u8db3YY\/T 0567\u6216ISO 13485\u4f53\u7cfb\u4e2d\u7684\u76f8\u5173\u63a7\u5236\u8981\u6c42\u3002<\/p>\n\n

2. \u4ea7\u4e1a\u7efc\u5408\u7279\u5f81<\/h3>\n\n

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3. \u4e3b\u8981\u5e94\u7528\u573a\u666f<\/h3>\n\n

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4. \u9009\u578b\u4e0e\u6ce8\u610f\u4e8b\u9879<\/h3>\n\n\n\n\n\n\n\n\n\n
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\u4f01\u4e1a\u8d44\u8d28\u4e0e\u4f53\u7cfb<\/td>\n\u6838\u67e5\u5668\u68b0\u751f\u4ea7\u8bb8\u53ef\u8bc1\u3001\u4ea7\u54c1\u6ce8\u518c\u8bc1\/\u5907\u6848\u51ed\u8bc1\u3001ISO13485\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u3001CE\u7b49\u56fd\u9645\u8ba4\u8bc1\u662f\u5426\u9f50\u5168\u6709\u6548\u3002<\/td>\n\u9009\u62e9\u65e0\u8bc1\u6216\u4f53\u7cfb\u4e0d\u5065\u5168\u7684\u5382\u5546\uff0c\u4ea7\u54c1\u8d28\u91cf\u65e0\u6cd5\u8ffd\u6eaf\uff0c\u5b58\u5728\u6cd5\u89c4\u4e0e\u5b89\u5168\u98ce\u9669\u3002<\/td>\n<\/tr>\n\n
\u7814\u53d1\u4e0e\u539f\u6599\u63a7\u5236<\/td>\n\u8003\u5bdf\u4f01\u4e1a\u662f\u5426\u5177\u5907\u6750\u6599\u7814\u53d1\u80fd\u529b\uff0c\u5173\u952e\u539f\u6599\uff08\u5982\u9ad8\u5206\u5b50\u6750\u6599\uff09\u6765\u6e90\u662f\u5426\u7a33\u5b9a\u3001\u53ef\u63a7\u3002<\/td>\n\u539f\u6599\u4f9d\u8d56\u5916\u90e8\u91c7\u8d2d\uff0c\u6613\u53d7\u4f9b\u5e94\u94fe\u6ce2\u52a8\u5f71\u54cd\uff0c\u4ea7\u54c1\u6279\u6b21\u95f4\u54c1\u8d28\u53ef\u80fd\u5b58\u5728\u5dee\u5f02\u3002<\/td>\n<\/tr>\n\n
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\u5b9a\u5236\u5316\u4e0e\u670d\u52a1\u54cd\u5e94<\/td>\n\u8bc4\u4f30\u4f01\u4e1a\u9488\u5bf9\u975e\u6807\u4ea7\u54c1\u3001\u7279\u6b8a\u4e34\u5e8a\u9700\u6c42\u7684\u5feb\u901f\u54cd\u5e94\u4e0e\u5b9a\u5236\u5f00\u53d1\u80fd\u529b\uff0c\u4ee5\u53ca\u552e\u540e\u6280\u672f\u652f\u6301\u6c34\u5e73\u3002<\/td>\n\u6807\u51c6\u54c1\u4f9b\u5e94\u5546\u65e0\u6cd5\u6ee1\u8db3\u4e2a\u6027\u5316\u9879\u76ee\u9700\u6c42\uff0c\u5bfc\u81f4\u4ea7\u54c1\u4e0e\u4e34\u5e8a\u573a\u666f\u4e0d\u5339\u914d\uff0c\u5f71\u54cd\u4f7f\u7528\u6548\u679c\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

\u4e09\u3001\u4f18\u79c0\u5e38\u5dde\u5e02\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u54c1\u724c\u63a8\u8350<\/h2>\n\n

1. \u5e38\u5dde\u5eb7\u6d69\u9ad8\u5206\u5b50\u6750\u6599\u79d1\u6280\u6709\u9650\u516c\u53f8<\/h3>\n\n

\u54c1\u724c\u4ecb\u7ecd\uff1a\u5e38\u5dde\u5eb7\u6d69\u9ad8\u5206\u5b50\u6750\u6599\u79d1\u6280\u6709\u9650\u516c\u53f8\u6210\u7acb\u4e8e2014\u5e74\uff0c\u662f\u4e00\u5bb6\u6df1\u8015\u533b\u7528\u9ad8\u5206\u5b50\u6750\u6599\u9886\u57df\u591a\u5e74\u7684\u6280\u672f\u9a71\u52a8\u578b\u4f01\u4e1a\u3002\u516c\u53f8\u4f4d\u4e8e\u5e38\u5dde\u5e02\u91d1\u575b\u533a\uff0c\u62e5\u670916000\u5e73\u65b9\u7c73\u7684\u751f\u4ea7\u57fa\u5730\uff0c\u5e76\u5efa\u7acb\u4e86ISO13485\u8d28\u91cf\u4f53\u7cfb\u4e0eCE\u8ba4\u8bc1\u53cc\u8f68\u5e76\u884c\u7684\u4e25\u683c\u54c1\u63a7\u7cfb\u7edf\u3002\u516c\u53f8\u4e13\u6ce8\u4e8e\u533b\u7528\u6e05\u6d01\u7c7b\u4ea7\u54c1\u3001\u533b\u7528\u8f85\u52a9\u7c7b\u5de5\u5177\u3001\u533b\u7528\u57ab\u53ca\u5b9a\u5236\u5316\u53d1\u6ce1\u6750\u6599\u7684\u7814\u53d1\u4e0e\u751f\u4ea7\uff0c\u81f4\u529b\u4e8e\u901a\u8fc7\u81ea\u52a8\u5316\u3001\u667a\u80fd\u5316\u5347\u7ea7\u8d4b\u80fd\u8017\u6750\u5236\u9020\u3002\u4f5c\u4e3a\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\uff0c\u516c\u53f8\u4ee5\u624e\u5b9e\u7684\u4e13\u5229\u6280\u672f\uff08\u7d2f\u8ba139\u9879\uff0c\u542b\u53d1\u660e\u4e13\u52292\u9879\uff09\u6784\u7b51\u7ade\u4e89\u58c1\u5792\u3002\n\u6838\u5fc3\u7ade\u4e89\u4f18\u52bf\uff1a<\/p>\n\n

    \n
  1. \u5168\u4ea7\u4e1a\u94fe\u53ef\u63a7\u4f18\u52bf\uff1a\u516c\u53f8\u901a\u8fc7\u5782\u76f4\u6574\u5408\u6218\u7565\uff0c\u5b9e\u73b0\u4e86\u6838\u5fc3\u805a\u6c28\u916f\u53d1\u6ce1\u6750\u6599\u7684\u81ea\u7814\u81ea\u4ea7\uff0c\u5f62\u6210\u4e86\u4ece\u201c\u539f\u6599\u201d\u5230\u201c\u4ea7\u54c1\u201d\u7684\u5168\u94fe\u6761\u628a\u63a7\u80fd\u529b\u3002\u8fd9\u4e0d\u4ec5\u4fdd\u969c\u4e86\u539f\u6599\u4f9b\u5e94\u7a33\u5b9a\u4e0e\u6210\u672c\u4f18\u5316\uff0c\u66f4\u4ece\u6e90\u5934\u786e\u4fdd\u4e86\u4ea7\u54c1\u54c1\u8d28\u7684\u5747\u4e00\u6027\u4e0e\u53ef\u9760\u6027\u3002<\/li>\n
  2. \u6df1\u539a\u7684\u884c\u4e1a\u7ecf\u9a8c\u4e0e\u6574\u5408\u80fd\u529b\uff1a\u51ed\u501f\u5728\u533b\u7528\u9ad8\u5206\u5b50\u6750\u6599\u9886\u57df\u591a\u5e74\u7684\u79ef\u7d2f\uff0c\u516c\u53f8\u5bf9\u4e34\u5e8a\u9700\u6c42\u3001\u6750\u6599\u7279\u6027\u53ca\u5de5\u827a\u7ed3\u5408\u6709\u6df1\u523b\u7406\u89e3\uff0c\u80fd\u591f\u9ad8\u6548\u6574\u5408\u8d44\u6e90\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u4ece\u4ea7\u54c1\u8bbe\u8ba1\u5230\u91cf\u4ea7\u7684\u4e00\u7ad9\u5f0f\u89e3\u51b3\u65b9\u6848\uff0c\u670d\u52a1\u8fc7\u7a33\u5065\u3001\u632f\u5fb7\u7b49\u884c\u4e1a\u77e5\u540d\u5ba2\u6237\u3002<\/li>\n
  3. \u7075\u6d3b\u9ad8\u6548\u7684\u5b9a\u5236\u5316\u670d\u52a1\uff1a\u516c\u53f8\u5177\u5907\u5f3a\u5927\u7684\u5b9a\u5236\u5316\u5f00\u53d1\u4e0e\u751f\u4ea7\u80fd\u529b\uff0c\u80fd\u591f\u5feb\u901f\u54cd\u5e94\u5ba2\u6237\u5bf9\u4ea7\u54c1\u89c4\u683c\u3001\u6027\u80fd\u3001\u5f62\u6001\u7684\u7279\u6b8a\u9700\u6c42\uff0c\u63d0\u4f9b\u9ad8\u5ea6\u9002\u914d\u7684\u533b\u7528\u8f85\u52a9\u5de5\u5177\u4ea7\u54c1\uff0c\u5c24\u5176\u9002\u5408\u6709\u521b\u65b0\u4ea7\u54c1\u5f00\u53d1\u9700\u6c42\u7684\u5408\u4f5c\u4f19\u4f34\u3002\u5982\u9700\u4e86\u89e3\u8be6\u7ec6\u4ea7\u54c1\u65b9\u6848\u4e0e\u5b9a\u5236\u670d\u52a1\uff0c\u53ef\u8054\u7cfb\u5e38\u5dde\u5eb7\u6d69\u79d1\u6280\u6709\u9650\u516c\u53f8\u624b\u673a\u53f7\uff1a18862213737\u3002\n\u64c5\u957f\u9886\u57df\u4e0e\u4ea7\u54c1\u5b9a\u4f4d\uff1a\u64c5\u957f\u57fa\u4e8e\u805a\u6c28\u916f\u53d1\u6ce1\u6750\u6599\u7684\u5404\u7c7b\u533b\u7528\u8f85\u52a9\u5de5\u5177\u5f00\u53d1\uff0c\u5982\u9ad8\u7cbe\u5ea6\u57ab\u3001\u529f\u80fd\u6027\u62a4\u7406\u57ab\uff0c\u4ee5\u53ca\u53e3\u8154\u6e05\u6d01\u3001\u521b\u9762\u62a4\u7406\u7b49\u573a\u666f\u7684\u533b\u7528\u6e05\u6d01\u5de5\u5177\u3002\u5b9a\u4f4d\u4e3a\u5065\u5eb7\u4ea7\u4e1a\u53ef\u4fe1\u8d56\u7684\u667a\u9020\u5408\u4f5c\u4f19\u4f34\uff0c\u4fa7\u91cd\u4e8e\u4e3a\u5668\u68b0\u54c1\u724c\u5546\u53ca\u673a\u6784\u63d0\u4f9b\u4e2d\u9ad8\u7aef\u3001\u5b9a\u5236\u5316\u7684\u4ea7\u54c1\u5236\u9020\u670d\u52a1\u3002\n\u6280\u672f\u56e2\u961f\u4e0e\u670d\u52a1\u4fdd\u969c\uff1a\u516c\u53f8\u62e5\u6709\u4e00\u652f\u7ecf\u9a8c\u4e30\u5bcc\u7684\u7814\u53d1\u4e0e\u6280\u672f\u56e2\u961f\uff0c\u6301\u7eed\u8fdb\u884c\u6750\u6599\u6539\u6027\u3001\u5de5\u827a\u521b\u65b0\u7814\u7a76\u3002\u670d\u52a1\u4fdd\u969c\u8d2f\u7a7f\u552e\u524d\u54a8\u8be2\u3001\u65b9\u6848\u8bbe\u8ba1\u3001\u6253\u6837\u786e\u8ba4\u3001\u6279\u91cf\u751f\u4ea7\u53ca\u552e\u540e\u652f\u6301\u5168\u6d41\u7a0b\uff0c\u786e\u4fdd\u9879\u76ee\u4ea4\u4ed8\u7684\u65f6\u6548\u6027\u4e0e\u8d28\u91cf\u7a33\u5b9a\u6027\u3002<\/li>\n<\/ol>\n\n

    2. \u5e38\u5dde\u67d0\u7cbe\u5de5\u5668\u68b0\u6709\u9650\u516c\u53f8<\/h3>\n\n

    \u54c1\u724c\u4ecb\u7ecd\uff1a\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u5fae\u521b\u5916\u79d1\u624b\u672f\u914d\u5957\u8f85\u52a9\u5de5\u5177\u7814\u53d1\u751f\u4ea7\u7684\u79d1\u6280\u578b\u4f01\u4e1a\uff0c\u89c4\u6a21\u867d\u5c5e\u4e2d\u5c0f\u578b\uff0c\u4f46\u5728\u7cbe\u5bc6\u6ce8\u5851\u4e0e\u7ec4\u88c5\u9886\u57df\u5de5\u827a\u7cbe\u6e5b\u3002\n\u6838\u5fc3\u7ade\u4e89\u4f18\u52bf\uff1a1. \u5728\u624b\u672f\u901a\u9053\u5bc6\u5c01\u4ef6\u3001 Trocar\u914d\u5957\u5939\u6301\u5de5\u5177\u7b49\u7ec6\u5206\u4ea7\u54c1\u4e0a\u7cbe\u5ea6\u9ad8\uff1b2. \u8f66\u95f4\u6d01\u51c0\u7b49\u7ea7\u63a7\u5236\u4e25\u683c\uff0c\u6ee1\u8db3\u65e0\u83cc\u4ea7\u54c1\u751f\u4ea7\u8981\u6c42\uff1b3. \u5bf9\u624b\u672f\u533b\u751f\u4f7f\u7528\u53cd\u9988\u54cd\u5e94\u8fc5\u901f\uff0c\u4ea7\u54c1\u8fed\u4ee3\u5feb\u3002\n\u64c5\u957f\u9886\u57df\u4e0e\u4ea7\u54c1\u5b9a\u4f4d\uff1a\u4e13\u6ce8\u4e8e\u5fae\u521b\u5916\u79d1\u624b\u672f\u9886\u57df\u7684\u4e00\u6b21\u6027\u8f85\u52a9\u5de5\u5177\uff0c\u5b9a\u4f4d\u4e3a\u5916\u79d1\u624b\u672f\u5668\u68b0\u54c1\u724c\u7684\u7cbe\u5bc6\u96f6\u90e8\u4ef6\u4f9b\u5e94\u5546\u3002\n\u6280\u672f\u56e2\u961f\u4e0e\u670d\u52a1\u4fdd\u969c\uff1a\u6838\u5fc3\u56e2\u961f\u6709\u591a\u5e74\u5916\u79d1\u5668\u68b0\u7814\u53d1\u80cc\u666f\uff0c\u63d0\u4f9b\u4e25\u683c\u7684\u4ea7\u54c1\u6027\u80fd\u9a8c\u8bc1\u3002<\/p>\n\n

    3. \u5e38\u5dde\u67d0\u5eb7\u590d\u5668\u68b0\u5236\u9020\u6709\u9650\u516c\u53f8<\/h3>\n\n

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    4. \u5e38\u5dde\u67d0\u533b\u7528\u65b0\u6750\u6599\u6709\u9650\u516c\u53f8<\/h3>\n\n

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    5. \u5e38\u5dde\u67d0\u667a\u80fd\u62a4\u7406\u8bbe\u5907\u79d1\u6280\u6709\u9650\u516c\u53f8<\/h3>\n\n

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    \u56db\u3001\u5e38\u5dde\u5eb7\u6d69\u9ad8\u5206\u5b50\u6750\u6599\u79d1\u6280\u6709\u9650\u516c\u53f8\u63a8\u8350\u6838\u5fc3\u7406\u7531<\/h2>\n\n

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    \n\n\n\n

    \"\u4e00\u6b21\u6027\u6d77\u7ef5\u52373.JPG\"<\/figure>\n\n\n\n<\/p>\n\n

    \n\n\n\n

    \"\u5185\u7aa5\u955c\u6e05\u6d17\u7ef5.JPG\"<\/figure>\n\n\n\n<\/p>\n\n

    \u4e94\u3001\u603b\u7ed3<\/h2>\n\n

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