\n\u6cd5\u89c4\u7b26\u5408\u6027<\/td>\n | \u90e8\u5206\u4e0d\u7b26\u5408\u65b0\u6807\u51c6<\/td>\n | \u6613\u8fbeISO 10993\u53caFDA\u8981\u6c42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u663e\u7136\uff0c\u6c34\u6027\u6d82\u6599\u5728\u73af\u4fdd\u4e0e\u5b89\u5168\u65b9\u9762\u5177\u6709\u538b\u5012\u6027\u4f18\u52bf\uff0c\u800c\u8fd9\u6b63\u662f\u6717\u76db\u6c34\u6027USC\u4ea7\u54c1\u5927\u5c55\u62f3\u811a\u7684\u821e\u53f0\u3002<\/p>\n \n\u7b2c\u4e8c\u7ae0\uff1a\u6717\u76db\u6c34\u6027USC\u4ea7\u54c1\u7684\u6838\u5fc3\u4f18\u52bf \ud83d\udd0d<\/h2>\n2.1 USC\u7cfb\u5217\u7b80\u4ecb\uff1a\u6765\u81ea\u5fb7\u56fd\u7684\u201c\u6e29\u67d4\u5b88\u62a4\u8005\u201d<\/h3>\nUSC<\/strong>\uff08Urethane Suspension Coating\uff09\uff0c\u5373\u805a\u6c28\u916f\u60ac\u6d6e\u6d82\u6599\uff0c\u662f\u6717\u76db\u4e13\u4e3a\u9ad8\u8981\u6c42\u5de5\u4e1a\u9886\u57df\u5f00\u53d1\u7684\u4e00\u7c7b\u9ad8\u6027\u80fd\u6c34\u6027\u6d82\u6599\u7cfb\u7edf\u3002\u5176\u7279\u70b9\u5728\u4e8e\uff1a<\/p>\n\n- \u57fa\u4e8e\u6c34\u5206\u6563\u4f53\u7cfb<\/li>\n
- \u62e5\u6709\u4f18\u5f02\u7684\u673a\u68b0\u6027\u80fd<\/li>\n
- \u53ef\u8c03\u7c98\u5ea6\u548c\u5149\u6cfd\u5ea6<\/li>\n
- \u6781\u4f73\u7684\u9644\u7740\u529b<\/li>\n
- \u7b26\u5408\u591a\u9879\u56fd\u9645\u533b\u7597\u7ea7\u5b89\u5168\u6807\u51c6<\/li>\n<\/ul>\n
2.2 \u4ea7\u54c1\u53c2\u6570\u4e00\u89c8\u8868 \ud83d\udcca<\/h3>\n\n\n\n\u53c2\u6570<\/th>\n | USC 710<\/th>\n | USC 750<\/th>\n | USC 800<\/th>\n<\/tr>\n<\/thead>\n | \n\n\u56fa\u542b\u91cf\uff08%\uff09<\/td>\n | 35<\/td>\n | 40<\/td>\n | 45<\/td>\n<\/tr>\n | \npH\u503c<\/td>\n | 7.0 – 8.5<\/td>\n | 7.0 – 8.5<\/td>\n | 7.0 – 8.5<\/td>\n<\/tr>\n | \n\u7c98\u5ea6\uff08mPa\u00b7s\uff09<\/td>\n | 100 – 200<\/td>\n | 150 – 300<\/td>\n | 200 – 400<\/td>\n<\/tr>\n | \n\u63a8\u8350\u56fa\u5316\u6e29\u5ea6\uff08\u2103\uff09<\/td>\n | 120<\/td>\n | 130<\/td>\n | 140<\/td>\n<\/tr>\n | \n\u5e72\u71e5\u65f6\u95f4\uff08min\uff09<\/td>\n | 15 – 30<\/td>\n | 20 – 40<\/td>\n | 25 – 50<\/td>\n<\/tr>\n | \n\u8010\u5316\u5b66\u6027<\/td>\n | \u4e2d\u7b49<\/td>\n | \u9ad8<\/td>\n | \u6781\u9ad8<\/td>\n<\/tr>\n | \n\u751f\u7269\u76f8\u5bb9\u6027\u7b49\u7ea7<\/td>\n | ISO 10993 Class II<\/td>\n | ISO 10993 Class III<\/td>\n | ISO 10993 Class IV<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u4ece\u53c2\u6570\u53ef\u89c1\uff0cUCS\u7cfb\u5217\u4ea7\u54c1\u968f\u7740\u578b\u53f7\u5347\u7ea7\uff0c\u5176\u529f\u80fd\u6027\u4e5f\u5728\u9010\u6b65\u589e\u5f3a\uff0c\u80fd\u591f\u6ee1\u8db3\u4ece\u666e\u901a\u533b\u7597\u5668\u68b0\u5230\u9ad8\u7aef\u53ef\u690d\u5165\u8bbe\u5907\u7684\u4e0d\u540c\u9700\u6c42\u3002<\/p>\n \n\u7b2c\u4e09\u7ae0\uff1a\u5e94\u7528\u573a\u666f\u4e0e\u6027\u80fd\u8868\u73b0 \u2728<\/h2>\n3.1 \u5178\u578b\u533b\u7597\u5668\u68b0\u5e94\u7528\u573a\u666f<\/h3>\n\n\n\n\u5e94\u7528\u7c7b\u578b<\/th>\n | \u4f7f\u7528\u79d1\u5ba4\/\u573a\u666f<\/th>\n | \u5bf9\u6d82\u6599\u7684\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n | \n\n\u5bfc\u7ba1\u7c7b\uff08\u5982\u5bfc\u5c3f\u7ba1\u3001\u8840\u7ba1\u5bfc\u7ba1\uff09<\/td>\n | ICU\u3001\u624b\u672f\u5ba4<\/td>\n | \u6297\u83cc\u3001\u6da6\u6ed1\u3001\u67d4\u6027<\/td>\n<\/tr>\n | \n\u5916\u79d1\u5668\u68b0\uff08\u5982\u526a\u5200\u3001\u94b3\u5b50\uff09<\/td>\n | \u624b\u672f\u5ba4\u3001\u6d88\u6bd2\u4e2d\u5fc3<\/td>\n | \u8010\u9ad8\u6e29\u9ad8\u538b\u3001\u6297\u8150\u8680<\/td>\n<\/tr>\n | \n\u5185\u7aa5\u955c\u5916\u58f3<\/td>\n | \u6d88\u5316\u79d1\u3001\u547c\u5438\u79d1<\/td>\n | \u9632\u5212\u4f24\u3001\u6613\u6e05\u6d01<\/td>\n<\/tr>\n | \n\u4eba\u5de5\u5173\u8282\u3001\u9aa8\u9489\u7b49\u690d\u5165\u5668\u68b0<\/td>\n | \u9aa8\u79d1\u3001\u5916\u79d1<\/td>\n | \u751f\u7269\u76f8\u5bb9\u6027\u9ad8\u3001\u65e0\u6bd2<\/td>\n<\/tr>\n | \n\u6025\u6551\u8bbe\u5907\u5916\u58f3<\/td>\n | \u6025\u8bca\u79d1\u3001ICU<\/td>\n | \u8010\u649e\u51fb\u3001\u9632\u6ed1\u3001\u9632\u9759\u7535<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n3.2 \u6027\u80fd\u5bf9\u6bd4\u5206\u6790<\/h3>\n\n\n\n\u6027\u80fd\u6307\u6807<\/th>\n | USC\u4ea7\u54c1<\/th>\n | \u4f20\u7edf\u6eb6\u5242\u578b\u6d82\u6599<\/th>\n | \u666e\u901a\u6c34\u6027\u6d82\u6599<\/th>\n<\/tr>\n<\/thead>\n | \n\n\u8010\u78e8\u6027<\/td>\n | \u2605\u2605\u2605\u2605\u2605<\/td>\n | \u2605\u2605\u2605\u2606\u2606<\/td>\n | \u2605\u2605\u2606\u2606\u2606<\/td>\n<\/tr>\n | \n\u751f\u7269\u76f8\u5bb9\u6027<\/td>\n | \u2605\u2605\u2605\u2605\u2605<\/td>\n | \u2605\u2605\u2606\u2606\u2606<\/td>\n | \u2605\u2605\u2605\u2606\u2606<\/td>\n<\/tr>\n | \n\u706d\u83cc\u517c\u5bb9\u6027<\/td>\n | \u2605\u2605\u2605\u2605\u2605<\/td>\n | \u2605\u2605\u2606\u2606\u2606<\/td>\n | \u2605\u2605\u2605\u2606\u2606<\/td>\n<\/tr>\n | \n\u73af\u4fdd\u7b49\u7ea7<\/td>\n | \u2605\u2605\u2605\u2605\u2605<\/td>\n | \u2605\u2606\u2606\u2606\u2606<\/td>\n | \u2605\u2605\u2605\u2605\u2606<\/td>\n<\/tr>\n | \n\u6210\u672c<\/td>\n | \u2605\u2605\u2605\u2606\u2606<\/td>\n | \u2605\u2605\u2606\u2606\u2606<\/td>\n | \u2605\u2605\u2605\u2605\u2606<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\u5c0f\u8d34\u58eb\ud83d\udca1\uff1aUSC\u7cfb\u5217\u4e0d\u4ec5\u5728\u6027\u80fd\u4e0a\u78be\u538b\uff0c\u8fd8\u80fd\u914d\u5408\u591a\u79cd\u706d\u83cc\u65b9\u5f0f\uff0c\u5982\u73af\u6c27\u4e59\u70f7\u3001\u03b3\u5c04\u7ebf\u3001\u84b8\u6c7d\u706d\u83cc\u7b49\uff0c\u9002\u7528\u8303\u56f4\u6781\u5e7f\uff01\n<\/p>\n<\/blockquote>\n \n\u7b2c\u56db\u7ae0\uff1a\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u4e0e\u6cd5\u89c4\u6807\u51c6 \ud83e\uddec\ud83d\udcdc<\/h2>\n4.1 \u6807\u51c6\u4f53\u7cfb\u6982\u89c8<\/h3>\n\u533b\u7597\u5668\u68b0\u6d82\u6599\u5fc5\u987b\u901a\u8fc7\u4e25\u82db\u7684\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\uff0c\u4e3b\u8981\u4f9d\u636e\u5982\u4e0b\u6807\u51c6\uff1a<\/p>\n \n- ISO 10993\u7cfb\u5217<\/strong>\uff1a\u533b\u7597\u5668\u68b0\u751f\u7269\u5b66\u8bc4\u4f30\u6807\u51c6<\/li>\n
- FDA 21 CFR Part 175<\/strong>\uff1a\u98df\u54c1\u63a5\u89e6\u6750\u6599\u76f8\u5173\u8981\u6c42\uff08\u90e8\u5206\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\uff09<\/li>\n
- REACH & RoHS\u6307\u4ee4<\/strong>\uff1a\u5316\u5b66\u54c1\u7ba1\u7406\u4e0e\u9650\u5236<\/li>\n<\/ul>\n
4.2 USC\u7cfb\u5217\u7684\u8ba4\u8bc1\u60c5\u51b5<\/h3>\n\n\n\n\u8ba4\u8bc1\u9879\u76ee<\/th>\n | USC\u7cfb\u5217\u662f\u5426\u901a\u8fc7\uff1f<\/th>\n | \u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n | \n\nISO 10993-10\uff1a\u523a\u6fc0\u4e0e\u81f4\u654f\u6027\u6d4b\u8bd5<\/td>\n | \u2714<\/td>\n | \u65e0\u523a\u6fc0\u3001\u65e0\u81f4\u654f<\/td>\n<\/tr>\n | \nISO 10993-5\uff1a\u7ec6\u80de\u6bd2\u6027\u6d4b\u8bd5<\/td>\n | \u2714<\/td>\n | \u7ec6\u80de\u5b58\u6d3b\u7387 >90%<\/td>\n<\/tr>\n | \nISO 10993-1\uff1a\u5168\u9762\u8bc4\u4f30\u8ba1\u5212<\/td>\n | \u2714<\/td>\n | \u5df2\u7eb3\u5165\u5168\u5957\u8bc4\u4f30\u6d41\u7a0b<\/td>\n<\/tr>\n | \nFDA\u6ce8\u518c<\/td>\n | \u2714<\/td>\n | \u5728\u7f8e\u56fd\u5e02\u573a\u53ef\u76f4\u63a5\u4f7f\u7528<\/td>\n<\/tr>\n | \nREACH SVHC\u6e05\u5355\u7b5b\u67e5<\/td>\n | \u2714<\/td>\n | \u65e0\u9ad8\u5ea6\u5173\u6ce8\u7269\u8d28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u53ef\u4ee5\u8bf4\uff0cUSC\u7cfb\u5217\u5df2\u7ad9\u5728\u56fd\u9645\u5408\u89c4\u7684\u7b2c\u4e00\u68af\u961f\uff0c\u662f\u5168\u7403\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u503c\u5f97\u4fe1\u8d56\u7684\u4f19\u4f34\u3002<\/p>\n \n\u7b2c\u4e94\u7ae0\uff1a\u5b9e\u9645\u6848\u4f8b\u5206\u4eab \ud83e\uddea\ud83d\udcd8<\/h2>\n5.1 \u6848\u4f8b\u4e00\uff1a\u67d0\u8de8\u56fd\u4f01\u4e1a\u5bfc\u7ba1\u6d82\u5c42\u9879\u76ee<\/h3>\n\n- \u5ba2\u6237\u80cc\u666f<\/strong>\uff1a\u6b27\u6d32\u5934\u90e8\u533b\u7597\u5668\u68b0\u5236\u9020\u5546 <\/li>\n
- \u6311\u6218<\/strong>\uff1a\u9700\u8981\u4e00\u6b3e\u517c\u5177\u6da6\u6ed1\u6027\u3001\u6297\u83cc\u6027\u548c\u751f\u7269\u76f8\u5bb9\u6027\u7684\u6d82\u5c42 <\/li>\n
- \u89e3\u51b3\u65b9\u6848<\/strong>\uff1a\u91c7\u7528USC 750+\u7eb3\u7c73\u6297\u83cc\u52a9\u5242 <\/li>\n
- \u6210\u679c<\/strong>\uff1a\u6210\u529f\u901a\u8fc7EN ISO 14971\u98ce\u9669\u7ba1\u7406\u8ba4\u8bc1\uff0c\u5bfc\u7ba1\u6469\u64e6\u7cfb\u6570\u964d\u4f4e40%\uff0c\u4e34\u5e8a\u53cd\u9988\u826f\u597d <\/li>\n<\/ul>\n
5.2 \u6848\u4f8b\u4e8c\uff1a\u56fd\u4ea7\u4eba\u5de5\u5173\u8282\u6d82\u5c42\u7814\u53d1\u5408\u4f5c<\/h3>\n\n- \u5ba2\u6237\u80cc\u666f<\/strong>\uff1a\u4e2d\u56fd\u67d0\u4e09\u7532\u533b\u9662\u5408\u4f5c\u7814\u53d1\u673a\u6784 <\/li>\n
- \u6311\u6218<\/strong>\uff1a\u6ee1\u8db3GB\/T 16886\u7cfb\u5217\u56fd\u5bb6\u6807\u51c6\u7684\u540c\u65f6\u964d\u4f4e\u6210\u672c <\/li>\n
- \u89e3\u51b3\u65b9\u6848<\/strong>\uff1a\u9009\u7528USC 800\u4f5c\u4e3a\u57fa\u7840\u6d82\u5c42\uff0c\u5e76\u4f18\u5316\u6d82\u5e03\u5de5\u827a <\/li>\n
- \u6210\u679c<\/strong>\uff1a\u6d82\u5c42\u539a\u5ea6\u63a7\u5236\u7cbe\u5ea6\u63d0\u5347\u81f3\u00b12\u03bcm\uff0c\u6210\u672c\u4e0b\u964d15%\uff0c\u540c\u65f6\u8fbe\u5230Class IV\u751f\u7269\u76f8\u5bb9\u6027\u6807\u51c6 <\/li>\n<\/ul>\n
\n\u7b2c\u516d\u7ae0\uff1a\u672a\u6765\u5c55\u671b\u2014\u2014\u533b\u7597\u5668\u68b0\u6d82\u6599\u7684\u201c\u7eff\u8272\u667a\u6167\u201d\u4e4b\u8def \ud83d\ude80\ud83c\udf31<\/h2>\n\u968f\u7740\u5168\u7403\u5bf9\u53ef\u6301\u7eed\u53d1\u5c55\u7684\u9ad8\u5ea6\u91cd\u89c6\uff0c\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4e5f\u5728\u79ef\u6781\u62e5\u62b1\u201c\u7eff\u8272\u5236\u9020\u201d\u3002\u6717\u76db\u6c34\u6027USC\u7cfb\u5217\u51ed\u501f\u5176\u73af\u4fdd\u3001\u9ad8\u6548\u3001\u53ef\u9760<\/strong>\u7684\u7279\u70b9\uff0c\u6b63\u6210\u4e3a\u65b0\u4e00\u4ee3\u533b\u7597\u5668\u68b0\u6d82\u5c42\u7684\u6807\u51c6\u9009\u62e9\u3002<\/p>\n\u672a\u6765\u7684\u53d1\u5c55\u65b9\u5411\u53ef\u80fd\u5305\u62ec\uff1a<\/p>\n \n- \u667a\u80fd\u5316\u6d82\u5c42<\/strong>\uff1a\u5177\u5907\u4f20\u611f\u3001\u81ea\u4fee\u590d\u7b49\u529f\u80fd<\/li>\n
- \u591a\u529f\u80fd\u96c6\u6210\u6d82\u5c42<\/strong>\uff1a\u96c6\u6da6\u6ed1\u3001\u6297\u83cc\u3001\u6297\u8840\u6813\u4e8e\u4e00\u4f53<\/li>\n
- AI\u8f85\u52a9\u914d\u65b9\u4f18\u5316<\/strong>\uff1a\u66f4\u5feb\u54cd\u5e94\u5e02\u573a\u9700\u6c42<\/li>\n
- \u78b3\u8db3\u8ff9\u8ffd\u8e2a\u7cfb\u7edf<\/strong>\uff1a\u8fdb\u4e00\u6b65\u63d0\u5347\u73af\u4fdd\u900f\u660e\u5ea6<\/li>\n<\/ul>\n
\u6b63\u5982\u4e00\u53e5\u53e4\u8bed\u6240\u8bf4\uff1a\u201c\u533b\u8005\u4ec1\u5fc3\uff0c\u5320\u8005\u5de7\u624b\u3002\u201d\u5728\u533b\u7597\u79d1\u6280\u4e0d\u65ad\u8fdb\u6b65\u7684\u4eca\u5929\uff0c\u6211\u4eec\u4e0d\u4ec5\u8981\u6cbb\u6108\u75be\u75c5\uff0c\u66f4\u8981\u5475\u62a4\u5730\u7403\u5bb6\u56ed\u3002\ud83c\udf0d\u2764\ufe0f<\/p>\n <\/p>\n
\n- \u667a\u80fd\u5316\u6d82\u5c42<\/strong>\uff1a\u5177\u5907\u4f20\u611f\u3001\u81ea\u4fee\u590d\u7b49\u529f\u80fd<\/li>\n
- \u591a\u529f\u80fd\u96c6\u6210\u6d82\u5c42<\/strong>\uff1a\u96c6\u6da6\u6ed1\u3001\u6297\u83cc\u3001\u6297\u8840\u6813\u4e8e\u4e00\u4f53<\/li>\n
- AI\u8f85\u52a9\u914d\u65b9\u4f18\u5316<\/strong>\uff1a\u66f4\u5feb\u54cd\u5e94\u5e02\u573a\u9700\u6c42<\/li>\n
- \u78b3\u8db3\u8ff9\u8ffd\u8e2a\u7cfb\u7edf<\/strong>\uff1a\u8fdb\u4e00\u6b65\u63d0\u5347\u73af\u4fdd\u900f\u660e\u5ea6<\/li>\n<\/ul>\n
\u6b63\u5982\u4e00\u53e5\u53e4\u8bed\u6240\u8bf4\uff1a\u201c\u533b\u8005\u4ec1\u5fc3\uff0c\u5320\u8005\u5de7\u624b\u3002\u201d\u5728\u533b\u7597\u79d1\u6280\u4e0d\u65ad\u8fdb\u6b65\u7684\u4eca\u5929\uff0c\u6211\u4eec\u4e0d\u4ec5\u8981\u6cbb\u6108\u75be\u75c5\uff0c\u66f4\u8981\u5475\u62a4\u5730\u7403\u5bb6\u56ed\u3002\ud83c\udf0d\u2764\ufe0f<\/p>\n \n | | | | |