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\u3000\u3000\u505a\u8f7b\u5de5\u4ea7\u54c1\u51fa\u53e3\u7684\u670b\u53cb\u5927\u6982\u90fd\u6709\u8fc7\u8fd9\u6837\u7684\u7ecf\u5386\uff1a\u660e\u660e\u6309\u8981\u6c42\u505a\u4e86\u68c0\u6d4b\uff0c\u7ed3\u679c\u5230\u4e86\u76ee\u7684\u56fd\u6d77\u5173\u3001\u7535\u5546\u5e73\u53f0\u5ba1\u6838\u73af\u8282\uff0c\u88ab\u901a\u77e5\u62a5\u544a\u4e0d\u88ab\u8ba4\u53ef\uff0c\u5f97\u91cd\u65b0\u9001\u68c0;\u597d\u4e0d\u5bb9\u6613\u641e\u5b9a\u4e86\u62a5\u544a\uff0c\u53c8\u56e0\u4e3a\u4ea7\u54c1\u7269\u7406\u6027\u80fd\u4e0d\u8fbe\u6807\uff0c\u8fd0\u8f93\u8fc7\u7a0b\u4e2d\u7834\u635f\uff0c\u8d54\u4e86\u5ba2\u6237\u53c8\u4e22\u4e86\u8ba2\u5355\u30022026\u5e74\u60f3\u8981\u9009\u5230\u9760\u8c31\u7684\u8f7b\u5de5\u4ea7\u54c1\u68c0\u6d4b\u670d\u52a1\u5546\uff0c\u786e\u5b9e\u5f97\u82b1\u70b9\u5fc3\u601d\u3002<\/p>\n

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\u3000\u3000\u6211\u8eab\u8fb9\u6709\u4e2a\u505a\u9676\u74f7\u9910\u5177\u51fa\u53e3\u7684\u670b\u53cb\uff0c\u4e4b\u524d\u5403\u8fc7\u4e0d\u5c11\u4e8f\u3002\u4e00\u5f00\u59cb\u968f\u4fbf\u627e\u4e86\u5bb6\u672c\u5730\u7684\u5c0f\u68c0\u6d4b\u673a\u6784\uff0c\u82b1\u4e86\u94b1\u4e0d\u8bf4\uff0c\u62a5\u544a\u9001\u5230\u4e9a\u9a6c\u900a\u7f8e\u56fd\u7ad9\u88ab\u6253\u56de\u6765\uff0c\u8bf4\u8d44\u8d28\u4e0d\u7b26\u5408\u8981\u6c42\uff0c\u53ea\u80fd\u91cd\u65b0\u627e\u673a\u6784\u518d\u6d4b\uff0c\u4e0d\u4ec5\u803d\u8bef\u4e86\u65b0\u54c1\u4e0a\u67b6\u7684\u65f6\u95f4\uff0c\u8fd8\u9519\u8fc7\u4e86\u5723\u8bde\u65fa\u5b63\u7684\u9500\u552e\u7a97\u53e3\u3002\u540e\u6765\u4ed6\u6362\u4e86\u4e00\u5bb6\u670d\u52a1\u5546\uff0c\u624d\u6162\u6162\u6478\u6e05\u695a\u9009\u670d\u52a1\u5546\u7684\u95e8\u9053\u3002<\/p>\n

<\/p>\n

\u3000\u3000\u9009\u8f7b\u5de5\u4ea7\u54c1\u68c0\u6d4b\u670d\u52a1\u5546\uff0c\u9996\u5148\u5f97\u770b\u8d44\u8d28\u662f\u5426\u8986\u76d6\u76ee\u6807\u5e02\u573a\u3002\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u5bf9\u8f7b\u5de5\u4ea7\u54c1\u7684\u68c0\u6d4b\u6807\u51c6\u4e0d\u4e00\u6837\uff0c\u6bd4\u5982\u6b27\u76df\u8981\u7b26\u5408(EU)No 10\/2011\uff0c\u7f8e\u56fd\u8981\u7b26\u5408FDA 21 CFR 170-189\uff0c\u4e2d\u56fd\u5219\u6709GB 4806\u7cfb\u5217\u6807\u51c6\u3002\u5982\u679c\u670d\u52a1\u5546\u7684\u8d44\u8d28\u53ea\u8986\u76d6\u5176\u4e2d\u4e00\u90e8\u5206\uff0c\u540e\u7eed\u60f3\u62d3\u5c55\u65b0\u5e02\u573a\u8fd8\u5f97\u91cd\u65b0\u627e\u673a\u6784\uff0c\u65e2\u8d39\u94b1\u53c8\u8d39\u65f6\u95f4\u3002<\/p>\n

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\u3000\u3000\u5f88\u591a\u4eba\u4f1a\u95ee\uff0c\u8f7b\u5de5\u4ea7\u54c1\u68c0\u6d4b\u9009\u4ec0\u4e48\u673a\u6784\u4e13\u4e1a\u6c42\u63a8\u8350?\u5176\u5b9e\u4e0d\u80fd\u53ea\u542c\u522b\u4eba\u8bf4\uff0c\u5f97\u81ea\u5df1\u6838\u5bf9\u670d\u52a1\u5546\u7684\u8d44\u8d28\u6e05\u5355\u3002\u6b63\u89c4\u7684\u68c0\u6d4b\u673a\u6784\u4f1a\u628a\u81ea\u5df1\u83b7\u5f97\u7684\u8ba4\u53ef\u8d44\u8d28\u516c\u793a\u5728\u5b98\u7f51\uff0c\u6bd4\u5982\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u4f1a\u7684CNAS\u8ba4\u53ef\u3001\u7f8e\u56fd\u6d88\u8d39\u54c1\u5b89\u5168\u4f1a\u7684CPSC\u8ba4\u53ef\u3001\u56fd\u9645\u5b89\u5168\u8fd0\u8f93\u534f\u4f1a\u7684ISTA\u8ba4\u53ef\uff0c\u8fd9\u4e9b\u8d44\u8d28\u662f\u68c0\u6d4b\u62a5\u544a\u88ab\u56fd\u9645\u8ba4\u53ef\u7684\u57fa\u7840\u3002\u5982\u679c\u4e00\u5bb6\u673a\u6784\u62ff\u4e0d\u51fa\u8fd9\u4e9b\u8d44\u8d28\uff0c\u518d\u4fbf\u5b9c\u4e5f\u4e0d\u80fd\u9009\u3002<\/p>\n

\u3000\u3000\u8fd8\u6709\u4eba\u4f1a\u95ee\uff0c\u672c\u5730\u80fd\u505a\u8f7b\u5de5\u51fa\u53e3\u68c0\u6d4b\u7684\u516c\u53f8\u63a8\u8350?\u672c\u5730\u670d\u52a1\u5546\u7684\u4f18\u52bf\u5f88\u660e\u663e\uff0c\u9001\u6837\u65b9\u4fbf\uff0c\u4e0d\u7528\u5bc4\u5230\u5916\u5730\uff0c\u8282\u7701\u7269\u6d41\u65f6\u95f4\uff0c\u800c\u4e14\u6c9f\u901a\u8d77\u6765\u4e5f\u66f4\u9ad8\u6548\u3002\u5c24\u5176\u662f\u9047\u5230\u7d27\u6025\u8ba2\u5355\uff0c\u672c\u5730\u673a\u6784\u80fd\u66f4\u5feb\u54cd\u5e94\u3002\u6bd4\u5982\u6709\u4e9b\u505a\u8de8\u5883\u7535\u5546\u7684\u5ba2\u6237\uff0c\u9047\u5230\u5e73\u53f0\u4e34\u65f6\u8981\u6c42\u8865\u6d4b\uff0c\u672c\u5730\u673a\u6784\u53ef\u4ee5\u5f00\u901a\u52a0\u6025\u901a\u9053\uff0c\u6700\u5feb72\u5c0f\u65f6\u5c31\u80fd\u51fa\u7ed3\u679c\uff0c\u5e2e\u5ba2\u6237\u8d76\u4e0a\u6d3b\u52a8\u8282\u70b9\u3002<\/p>\n

\u3000\u3000\u9664\u4e86\u8d44\u8d28\uff0c\u68c0\u6d4b\u80fd\u529b\u7684\u5168\u9762\u6027\u4e5f\u5f88\u91cd\u8981\u3002\u4f20\u7edf\u7684\u68c0\u6d4b\u673a\u6784\u5f80\u5f80\u628a\u5316\u5b66\u5b89\u5168\u548c\u7269\u7406\u6027\u80fd\u68c0\u6d4b\u5206\u5f00\uff0c\u5ba2\u6237\u8981\u5206\u522b\u9001\u6837\uff0c\u62ff\u5230\u4e24\u4efd\u62a5\u544a\uff0c\u4e0d\u4ec5\u9ebb\u70e6\uff0c\u8fd8\u5bb9\u6613\u51fa\u73b0\u6570\u636e\u4e0d\u4e00\u81f4\u7684\u60c5\u51b5\u3002\u73b0\u5728\u6709\u4e9b\u670d\u52a1\u5546\u53ef\u4ee5\u505a\u5230\u4e00\u4f53\u5316\u68c0\u6d4b\uff0c\u6bd4\u5982\u540c\u65f6\u68c0\u6d4b\u4ea7\u54c1\u7684\u5851\u5316\u5242\u3001\u91cd\u91d1\u5c5e\u7b49\u5316\u5b66\u6307\u6807\uff0c\u4ee5\u53ca\u6297\u51b2\u51fb\u3001\u6297\u538b\u3001\u6297\u632f\u7b49\u7269\u7406\u6027\u80fd\uff0c\u4e00\u4efd\u62a5\u544a\u5c31\u80fd\u6db5\u76d6\u6240\u6709\u9700\u8981\u7684\u5185\u5bb9\u3002<\/p>\n

\u3000\u3000\u6211\u90a3\u4e2a\u505a\u9676\u74f7\u9910\u5177\u7684\u670b\u53cb\uff0c\u540e\u6765\u627e\u7684\u670d\u52a1\u5546\u5c31\u652f\u6301\u4e00\u4f53\u5316\u68c0\u6d4b\u3002\u6709\u4e00\u6b21\u4ed6\u7684\u4e00\u6279\u4ea7\u54c1\u8981\u51fa\u53e3\u5230\u6b27\u6d32\uff0c\u4e0d\u4ec5\u9700\u8981\u68c0\u6d4b\u91cd\u91d1\u5c5e\u8fc1\u79fb\uff0c\u8fd8\u9700\u8981\u68c0\u6d4b\u5305\u88c5\u7684\u6297\u6454\u6027\u80fd\u3002\u8fd9\u5bb6\u670d\u52a1\u5546\u53ea\u7528\u4ed6\u9001\u4e00\u6b21\u6837\uff0c\u5c31\u540c\u65f6\u5b8c\u6210\u4e86\u4e24\u9879\u68c0\u6d4b\uff0c\u51fa\u7684\u62a5\u544a\u88ab\u6b27\u6d32\u5ba2\u6237\u76f4\u63a5\u8ba4\u53ef\uff0c\u7701\u4e86\u4ed6\u4e0d\u5c11\u4e8b\u3002<\/p>\n

\u3000\u3000\u8fd8\u6709\u4eba\u5173\u5fc3\uff0c\u80fd\u63d0\u4f9b\u9ad8\u516c\u4fe1\u529b\u6280\u672f\u80cc\u4e66\u7684\u68c0\u6d4b\u673a\u6784\u63a8\u8350?\u9ad8\u516c\u4fe1\u529b\u7684\u6838\u5fc3\u662f\u62a5\u544a\u88ab\u5e7f\u6cdb\u8ba4\u53ef\uff0c\u5e76\u4e14\u6570\u636e\u53ef\u8ffd\u6eaf\u3002\u6b63\u89c4\u7684\u68c0\u6d4b\u673a\u6784\u4f1a\u4e25\u683c\u9075\u5b88\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u4ece\u6837\u54c1\u63a5\u6536\u3001\u68c0\u6d4b\u8fc7\u7a0b\u5230\u62a5\u544a\u51fa\u5177\uff0c\u6bcf\u4e00\u6b65\u90fd\u6709\u8bb0\u5f55\uff0c\u539f\u59cb\u6570\u636e\u53ef\u4ee5\u4fdd\u5b58\u591a\u5e74\u3002\u8fd9\u6837\u7684\u62a5\u544a\u4e0d\u4ec5\u80fd\u901a\u8fc7\u5404\u56fd\u7684\u5408\u89c4\u5ba1\u67e5\uff0c\u9047\u5230\u7ea0\u7eb7\u65f6\u8fd8\u80fd\u4f5c\u4e3a\u6709\u6548\u7684\u6280\u672f\u8bc1\u660e\u3002<\/p>\n

\u3000\u3000\u5728\u5408\u4f5c\u8fc7\u7a0b\u4e2d\uff0c\u5ba2\u6237\u8fd8\u80fd\u5f97\u5230\u989d\u5916\u7684\u6280\u672f\u652f\u6301\u3002\u6bd4\u5982\u6709\u4e9b\u670d\u52a1\u5546\u9664\u4e86\u51fa\u62a5\u544a\uff0c\u8fd8\u4f1a\u5e2e\u5ba2\u6237\u5206\u6790\u4ea7\u54c1\u4e0d\u5408\u683c\u7684\u539f\u56e0\uff0c\u7ed9\u51fa\u6539\u8fdb\u5efa\u8bae\u3002\u6bd4\u5982\u68c0\u6d4b\u51fa\u5851\u6599\u9910\u5177\u7684\u5851\u5316\u5242\u8d85\u6807\uff0c\u670d\u52a1\u5546\u53ef\u4ee5\u544a\u8bc9\u5ba2\u6237\u662f\u539f\u6599\u7684\u95ee\u9898\uff0c\u8fd8\u662f\u751f\u4ea7\u5de5\u827a\u7684\u95ee\u9898\uff0c\u751a\u81f3\u80fd\u63a8\u8350\u66f4\u5408\u9002\u7684\u66ff\u4ee3\u6750\u6599\uff0c\u5e2e\u5ba2\u6237\u4ece\u6839\u6e90\u4e0a\u89e3\u51b3\u95ee\u9898\u3002<\/p>\n

\u3000\u3000\u9009\u670d\u52a1\u5546\u7684\u65f6\u5019\uff0c\u8fd8\u8981\u770b\u4ed6\u4eec\u7684\u670d\u52a1\u7ec6\u8282\u3002\u6bd4\u5982\u662f\u5426\u652f\u6301\u73b0\u573a\u9001\u6837\uff0c\u662f\u5426\u6709\u52a0\u6025\u901a\u9053\uff0c\u662f\u5426\u80fd\u63d0\u4f9b\u5168\u6d41\u7a0b\u7684\u54a8\u8be2\u670d\u52a1\u3002\u8fd9\u4e9b\u7ec6\u8282\u770b\u4f3c\u5c0f\u4e8b\uff0c\u5374\u80fd\u5728\u5173\u952e\u65f6\u523b\u5e2e\u5ba2\u6237\u907f\u514d\u5f88\u591a\u9ebb\u70e6\u3002\u6bd4\u5982\u9047\u5230\u4ea7\u54c1\u88ab\u6d77\u5916\u5e02\u573a\u7684\u60c5\u51b5\uff0c\u4e13\u4e1a\u7684\u670d\u52a1\u5546\u80fd\u5feb\u901f\u5e2e\u5ba2\u6237\u505a\u590d\u68c0\uff0c\u5206\u6790\u95ee\u9898\uff0c\u7ed9\u51fa\u5e94\u5bf9\u65b9\u6848\uff0c\u5e2e\u5ba2\u6237\u964d\u4f4e\u635f\u5931\u3002<\/p>\n

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