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\u5e72\u70ed\u706d\u83cc\u5219\u9700\u8981\u7279\u522b\u5173\u6ce8\u5347\u6e29\u901f\u7387\u548c\u51b7\u5374\u66f2\u7ebf\u7684\u63a7\u5236\u3002\u6839\u636e\u7f8e\u56fdFDA\u53d1\u5e03\u7684\u6307\u5bfc\u539f\u5219\uff0c\u5efa\u8bae\u5c06\u5347\u6e29\u901f\u7387\u63a7\u5236\u5728\u6bcf\u5206\u949f\u4e0d\u8d85\u8fc75\u2103\uff0c\u4ee5\u907f\u514d\u6750\u6599\u56e0\u9aa4\u7136\u5347\u6e29\u548c\u964d\u6e29\u800c\u4ea7\u751f\u5e94\u529b\u88c2\u7eb9\u3002\u540c\u65f6\uff0c\u706d\u83cc\u8154\u5ba4\u5185\u5e94\u4fdd\u6301\u9002\u5f53\u7684\u7a7a\u6c14\u6d41\u901f\uff08\u901a\u5e38\u4e3a0.5-1.0\u7c73\/\u79d2\uff09\uff0c\u4ee5\u786e\u4fdd\u70ed\u91cf\u5747\u5300\u5206\u5e03\u3002\u4e3a\u4e86\u76d1\u6d4b\u706d\u83cc\u6548\u679c\uff0c\u53ef\u4ee5\u4f7f\u7528\u751f\u7269\u6307\u793a\u5242\uff08\u5982\u55dc\u70ed\u8102\u80aa\u82bd\u5b62\u6746\u83cc\u5b62\u5b50\uff09\u8fdb\u884c\u9a8c\u8bc1\u5b9e\u9a8c\u3002<\/p>\n

\u8f90\u5c04\u706d\u83cc\u7684\u64cd\u4f5c\u91cd\u70b9\u5728\u4e8e\u5242\u91cf\u5206\u5e03\u7684\u5747\u5300\u6027\u63a7\u5236\u3002\u6839\u636eISO 11137\u6807\u51c6\uff0c\u63a8\u8350\u7684\u03b3\u5c04\u7ebf\u8f90\u5c04\u5242\u91cf\u8303\u56f4\u4e3a25kGy\u81f350kGy\u3002\u5b9e\u9645\u64cd\u4f5c\u4e2d\u9700\u8981\u901a\u8fc7\u5242\u91cf\u8ba1\u6d4b\u91cf\u4e0d\u540c\u4f4d\u7f6e\u7684\u8f90\u5c04\u5242\u91cf\uff0c\u5e76\u7ed8\u5236\u5242\u91cf\u5206\u5e03\u56fe\u4ee5\u786e\u8ba4\u5747\u5300\u6027\u3002\u540c\u65f6\uff0c\u5e94\u6ce8\u610f\u5c4f\u853d\u9632\u62a4\u63aa\u65bd\uff0c\u786e\u4fdd\u64cd\u4f5c\u4eba\u5458\u7684\u5b89\u5168\u3002\u5bf9\u4e8e\u7535\u5b50\u675f\u706d\u83cc\uff0c\u8fd8\u9700\u8003\u8651\u7535\u5b50\u675f\u80fd\u91cf\uff08\u901a\u5e38\u4e3a5MeV\u81f310MeV\uff09\u5bf9\u6750\u6599\u6027\u80fd\u7684\u5f71\u54cd\u3002<\/p>\n

\u5316\u5b66\u706d\u83cc\u65b9\u6cd5\u4e2d\uff0c\u73af\u6c27\u4e59\u70f7\u706d\u83cc\u9700\u8981\u5efa\u7acb\u5b8c\u5584\u7684\u6c14\u4f53\u6d53\u5ea6\u76d1\u63a7\u7cfb\u7edf\u3002\u6839\u636eASTM E1151\u6807\u51c6\uff0c\u706d\u83cc\u73af\u5883\u4e2d\u7684\u73af\u6c27\u4e59\u70f7\u6d53\u5ea6\u5e94\u7ef4\u6301\u5728600mg\/L\u81f31200mg\/L\u4e4b\u95f4\uff0c\u76f8\u5bf9\u6e7f\u5ea6\u63a7\u5236\u572860%\u81f380%\uff0c\u6e29\u5ea6\u4fdd\u6301\u572850\u2103\u81f360\u2103\u3002\u706d\u83cc\u5b8c\u6210\u540e\uff0c\u5fc5\u987b\u8fdb\u884c\u5145\u5206\u7684\u901a\u98ce\u6392\u6c14\uff0c\u5e76\u901a\u8fc7\u6c14\u76f8\u8272\u8c31\u6cd5\u68c0\u6d4b\u6b8b\u7559\u91cf\uff0c\u786e\u4fdd\u4f4e\u4e8e10ppm\u7684\u5b89\u5168\u9650\u503c\u3002<\/p>\n

\u8fc7\u6c27\u5316\u6c22\u7b49\u79bb\u5b50\u4f53\u706d\u83cc\u5219\u9700\u8981\u7cbe\u786e\u63a7\u5236\u8fc7\u6c27\u5316\u6c22\u84b8\u6c7d\u6d53\u5ea6\u548c\u7b49\u79bb\u5b50\u4f53\u6fc0\u53d1\u529f\u7387\u3002\u6839\u636eEN ISO 14937\u6807\u51c6\uff0c\u63a8\u8350\u7684\u8fc7\u6c27\u5316\u6c22\u6d53\u5ea6\u8303\u56f4\u4e3a6mg\/L\u81f310mg\/L\uff0c\u7b49\u79bb\u5b50\u4f53\u6fc0\u53d1\u529f\u7387\u4e3a100W\u81f3300W\u3002\u706d\u83cc\u8154\u5ba4\u5185\u7684\u76f8\u5bf9\u6e7f\u5ea6\u5e94\u63a7\u5236\u572830%\u81f350%\uff0c\u4ee5\u4fdd\u8bc1\u7b49\u79bb\u5b50\u4f53\u7684\u7a33\u5b9a\u751f\u6210\u3002\u540c\u65f6\uff0c\u9700\u8981\u914d\u5907\u4e13\u4e1a\u7684\u751f\u7269\u8d1f\u8f7d\u68c0\u6d4b\u7cfb\u7edf\uff0c\u5b9a\u671f\u9a8c\u8bc1\u706d\u83cc\u6548\u679c\u3002<\/p>\n

\u4e0b\u8868\u5217\u51fa\u4e86\u5404\u706d\u83cc\u65b9\u6cd5\u7684\u5173\u952e\u53c2\u6570\u63a7\u5236\u8303\u56f4\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n
\u706d\u83cc\u65b9\u6cd5<\/th>\n\u5173\u952e\u53c2\u6570<\/th>\n\u63a7\u5236\u8303\u56f4<\/th>\n\u76d1\u6d4b\u9891\u7387<\/th>\n<\/tr>\n<\/thead>\n
\u6e7f\u70ed\u706d\u83cc<\/td>\n\u6e29\u5ea6<\/td>\n121-134\u2103<\/td>\n\u6bcf\u6b21\u706d\u83cc\u524d<\/td>\n<\/tr>\n
\u5e72\u70ed\u706d\u83cc<\/td>\n\u5347\u6e29\u901f\u7387<\/td>\n\u22645\u2103\/min<\/td>\n\u6bcf\u5468\u4e00\u6b21<\/td>\n<\/tr>\n
\u8f90\u5c04\u706d\u83cc<\/td>\n\u5242\u91cf<\/td>\n25-50kGy<\/td>\n\u6bcf\u6279\u6b21<\/td>\n<\/tr>\n
\u73af\u6c27\u4e59\u70f7\u706d\u83cc<\/td>\n\u6d53\u5ea6<\/td>\n600-1200mg\/L<\/td>\n\u6bcf\u6279\u6b21<\/td>\n<\/tr>\n
\u8fc7\u6c27\u5316\u6c22\u7b49\u79bb\u5b50\u4f53\u706d\u83cc<\/td>\n\u6d53\u5ea6<\/td>\n6-10mg\/L<\/td>\n\u6bcf\u5929\u4e00\u6b21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u706d\u83cc\u65b9\u6cd5\u5bf9\u56ca\u5f0f\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u5f71\u54cd\u5206\u6790<\/h2>\n

\u4e0d\u540c\u706d\u83cc\u65b9\u6cd5\u5bf9\u56ca\u5f0f\u8fc7\u6ee4\u5668\u7684\u7269\u7406\u548c\u5316\u5b66\u6027\u80fd\u4f1a\u4ea7\u751f\u663e\u8457\u5f71\u54cd\u3002\u6e7f\u70ed\u706d\u83cc\u867d\u7136\u80fd\u63d0\u4f9b\u53ef\u9760\u7684\u706d\u83cc\u6548\u679c\uff0c\u4f46\u5176\u9ad8\u6e29\u9ad8\u538b\u6761\u4ef6\u53ef\u80fd\u5f15\u8d77\u8fc7\u6ee4\u819c\u6750\u6599\u7684\u70ed\u964d\u89e3\u3002\u7814\u7a76\u8868\u660e\uff0cPES\u6750\u8d28\u5728\u7ecf\u8fc7\u591a\u6b21134\u2103\u6e7f\u70ed\u706d\u83cc\u5faa\u73af\u540e\uff0c\u5176\u62c9\u4f38\u5f3a\u5ea6\u4f1a\u4e0b\u964d\u7ea615%-20%\uff0c\u5b54\u5f84\u5206\u5e03\u4e5f\u53ef\u80fd\u53d1\u751f\u8f7b\u5fae\u53d8\u5316\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0cPVDF\u6750\u8d28\u8868\u73b0\u51fa\u66f4\u597d\u7684\u70ed\u7a33\u5b9a\u6027\uff0c\u5373\u4f7f\u7ecf\u8fc720\u6b21\u4ee5\u4e0a\u7684\u6e7f\u70ed\u706d\u83cc\u5faa\u73af\uff0c\u5176\u673a\u68b0\u6027\u80fd\u4ecd\u80fd\u4fdd\u6301\u5728\u521d\u59cb\u503c\u768490%\u4ee5\u4e0a\u3002<\/p>\n

\u5e72\u70ed\u706d\u83cc\u5bf9\u8fc7\u6ee4\u5668\u6750\u6599\u7684\u5f71\u54cd\u4e3b\u8981\u4f53\u73b0\u5728\u6c27\u5316\u8001\u5316\u65b9\u9762\u3002\u957f\u671f\u66b4\u9732\u5728\u9ad8\u6e29\u7a7a\u6c14\u4e2d\u4f1a\u5bfc\u81f4\u805a\u5408\u7269\u5206\u5b50\u94fe\u7684\u6c27\u5316\u65ad\u88c2\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u542b\u4e0d\u9971\u548c\u952e\u7684\u6750\u6599\u5982\u5c3c\u9f9966\u3002\u6839\u636e\u4e00\u9879\u53d1\u8868\u5728Journal of Membrane Science\u7684\u7814\u7a76\u663e\u793a\uff0c\u5c3c\u9f99\u6750\u8d28\u8fc7\u6ee4\u5668\u5728\u7ecf\u53865\u6b21180\u2103\u5e72\u70ed\u706d\u83cc\u540e\uff0c\u5176\u8868\u9762\u63a5\u89e6\u89d2\u7531\u521d\u768472\u00b0\u964d\u81f365\u00b0\uff0c\u8868\u660e\u758f\u6c34\u6027\u80fd\u6709\u6240\u4e0b\u964d\u3002\u7136\u800c\uff0c\u8fd9\u79cd\u53d8\u5316\u901a\u5e38\u4e0d\u4f1a\u663e\u8457\u5f71\u54cd\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u529f\u80fd\u3002<\/p>\n

\u8f90\u5c04\u706d\u83cc\u5bf9\u6750\u6599\u6027\u80fd\u7684\u5f71\u54cd\u53d6\u51b3\u4e8e\u8f90\u5c04\u5242\u91cf\u548c\u6750\u6599\u7c7b\u578b\u3002\u9002\u5ea6\u7684\u8f90\u5c04\u5242\u91cf\uff08<30kGy\uff09\u901a\u5e38\u4e0d\u4f1a\u5bf9\u8fc7\u6ee4\u5668\u6027\u80fd\u9020\u6210\u660e\u663e\u635f\u5bb3\uff0c\u4f46\u8fc7\u9ad8\u7684\u5242\u91cf\u53ef\u80fd\u5bfc\u81f4\u5206\u5b50\u94fe\u65ad\u88c2\u548c\u4ea4\u8054\u53cd\u5e94\u3002\u4e00\u9879\u7531European Journal of Pharmaceutics and Biopharmaceutics\u53d1\u8868\u7684\u7814\u7a76\u6307\u51fa\uff0c\u5f53\u8f90\u5c04\u5242\u91cf\u8d85\u8fc750kGy\u65f6\uff0cPVDF\u6750\u8d28\u7684\u62c9\u4f38\u6a21\u91cf\u4f1a\u964d\u4f4e\u7ea625%\uff0c\u540c\u65f6\u8868\u9762\u7c97\u7cd9\u5ea6\u589e\u52a0\uff0c\u53ef\u80fd\u5f71\u54cd\u8fc7\u6ee4\u6548\u7387\u3002<\/p>\n

\u5316\u5b66\u706d\u83cc\u65b9\u6cd5\u5bf9\u6750\u6599\u6027\u80fd\u7684\u5f71\u54cd\u76f8\u5bf9\u590d\u6742\u3002\u73af\u6c27\u4e59\u70f7\u706d\u83cc\u53ef\u80fd\u4f1a\u5bfc\u81f4\u6750\u6599\u8868\u9762\u53d1\u751f\u8f7b\u5fae\u7684\u5316\u5b66\u4fee\u9970\uff0c\u6539\u53d8\u5176\u4eb2\u758f\u6c34\u7279\u6027\u3002\u7814\u7a76\u53d1\u73b0\uff0c\u7ecf\u8fc7\u73af\u6c27\u4e59\u70f7\u706d\u83cc\u5904\u7406\u540e\uff0cPES\u6750\u8d28\u7684\u8868\u9762\u80fd\u589e\u52a0\u4e86\u7ea610%-15%\uff0c\u8fd9\u53ef\u80fd\u4f1a\u7565\u5fae\u6539\u5584\u8fc7\u6ee4\u5668\u7684\u6da6\u6e7f\u6027\u80fd\u3002\u7136\u800c\uff0c\u5982\u679c\u706d\u83cc\u540e\u672a\u8fdb\u884c\u5145\u5206\u7684\u6392\u6c14\u5904\u7406\uff0c\u6b8b\u7559\u5728\u6750\u6599\u4e2d\u7684\u73af\u6c27\u4e59\u70f7\u53ef\u80fd\u9010\u6e10\u91ca\u653e\u5e76\u5f71\u54cd\u8fc7\u6ee4\u5668\u7684\u957f\u671f\u7a33\u5b9a\u6027\u3002<\/p>\n

\u4e0b\u8868\u603b\u7ed3\u4e86\u4e0d\u540c\u706d\u83cc\u65b9\u6cd5\u5bf9\u56ca\u5f0f\u8fc7\u6ee4\u5668\u4e3b\u8981\u6027\u80fd\u6307\u6807\u7684\u5f71\u54cd\u7a0b\u5ea6\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u706d\u83cc\u65b9\u6cd5<\/th>\n\u529b\u5b66\u6027\u80fd\u5f71\u54cd<\/th>\n\u5b54\u5f84\u53d8\u5316<\/th>\n\u8868\u9762\u6027\u8d28\u6539\u53d8<\/th>\n\u4f7f\u7528\u5bff\u547d\u5f71\u54cd<\/th>\n<\/tr>\n<\/thead>\n
\u6e7f\u70ed\u706d\u83cc<\/td>\n\u4e2d\u7b49<\/td>\n\u8f7b\u5fae<\/td>\n\u8f7b\u5fae<\/td>\n\u4e2d\u7b49<\/td>\n<\/tr>\n
\u5e72\u70ed\u706d\u83cc<\/td>\n\u8f83\u5927<\/td>\n\u8f7b\u5fae<\/td>\n\u663e\u8457<\/td>\n\u8f83\u5927<\/td>\n<\/tr>\n
\u8f90\u5c04\u706d\u83cc<\/td>\n\u53d6\u51b3\u4e8e\u5242\u91cf<\/td>\n\u8f7b\u5fae<\/td>\n\u8f7b\u5fae<\/td>\n\u53d6\u51b3\u4e8e\u5242\u91cf<\/td>\n<\/tr>\n
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\u53c2\u8003\u6587\u732e\u6765\u6e90<\/h2>\n

[1] \u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u534f\u4f1a. (2022). \u533b\u836f\u751f\u4ea7\u8bbe\u5907\u6280\u672f\u624b\u518c[M]. \u5317\u4eac: \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e.<\/p>\n

[2] ASTM E1151. (2020). Standard Specification for Ethylene Oxide Sterilization of Medical Devices [S].<\/p>\n

[3] EN ISO 14937. (2019). Sterilization of health care products – Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices [S].<\/p>\n

[4] ISO 11137. (2015). Sterilization of health care products – Radiation – Requirements for development, validation and routine control of a sterilization process for medical devices [S].<\/p>\n

[5] Journal of Membrane Science. (2021). Effects of dry heat sterilization on nylon membrane filters [J].<\/p>\n

[6] European Journal of Pharmaceutics and Biopharmaceutics. (2020). Impact of gamma radiation on PVDF filter performance [J].<\/p>\n

[7] Fraunhofer Institute for Manufacturing Technology and Advanced Materials. (2022). Pulse UV Sterilization Technology Report [R].<\/p>\n

[8] Eastman Kodak Company. (2021). Smart Sterilization System Application Guide [R].<\/p>\n

[9] Tsinghua University & Shanghai Institute of Pharmaceutical Industry. (2022). Research Progress on Nano-composite Membrane Materials [R].<\/p>\n

[10] 3M Company. (2022). Composite Sterilization Process Technical Manual [R].<\/p>\n

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