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\u901a\u8fc7ISO13485\uff1a2016\u8ba4\u8bc1\uff0c\u4e0d\u4ec5\u8bc1\u660e\u5728\u6709\u8d28\u91cf\u4fdd\u8bc1\u7684\u4f53\u7cfb\u4e0b\uff0c\u62d3\u666e\u8054\u79d1\u80fd\u591f\u6301\u7eed\u63d0\u4f9b\u9ad8\u54c1\u8d28\u3001\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u5ba2\u6237\u9700\u6c42\u7684\u4ea7\u54c1\uff0c\u66f4\u8bf4\u660e\u6211\u4eec\u516c\u53f8\u7684\u5bf9\u4ea7\u54c1\u54c1\u8d28\u6807\u51c6\u7684\u66f4\u9ad8\u8981\u6c42\u3002\u672c\u6b21ISO13485\uff1a2016\u8ba4\u8bc1\u7684\u987a\u5229\u901a\u8fc7\uff0c\u8ba9\u516c\u53f8\u5728\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6cd5\u89c4\u65b9\u9762\u66f4\u52a0\u5145\u6ee1\u4fe1\u5fc3\u3002<\/p>\n
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2020\u5e7412\u6708\uff0c\u62d3\u666e\u8054\u79d1\u901a\u8fc7ISO13485:2016\u201c\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u201d\u8ba4\u8bc1\uff0c\u5e76\u5df2\u53d6\u5f97\u76f8\u5173\u8bc1\u4e66\u3002\u901a\u8fc7ISO13485\uff1a2016\u8ba4\u8bc1\uff0c\u6807\u81f4\u7740\u62d3\u666e\u8054\u79d1\u80fd\u591f\u6301\u7eed\u63d0\u4f9b\u9ad8\u54c1\u8d28\u3001\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u5ba2\u6237\u9700\u6c42\u7684\u4ea7\u54c1\u3002<\/p>\n","protected":false},"author":2,"featured_media":1379,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"iawp_total_views":0,"footnotes":""},"categories":[3],"tags":[274,275,73],"class_list":["post-1378","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-iso134852016","tag-yiliaoqixiezhi","tag-tuopulianke"],"acf":[],"yoast_head":"
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\nISO 13485\u6807\u51c6\u662f\u300a\u533b\u7597\u5668\u68b0 \u2013 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb \u2013 \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u300b(Medical devices \u2013 Quality management systems \u2013Requirements for regulatory purposes)\uff0c\u5b83\u5df2\u6210\u4e3a\u4ece\u4e8b\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u7684\u5168\u7403\u6807\u51c6\u3002ISO 13485 \u4e2d\u6587\u53eb\u201c\u533b\u7597\u5668\u68b0 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u201d \u7531\u4e8e\u533b\u7597\u5668\u68b0\u662f\u6551\u6b7b\u6276\u4f24\u3001\u9632\u75c5\u6cbb\u75c5\u7684\u7279\u6b8a\u4ea7\u54c1\uff0c\u4ec5\u6309ISO9000\u6807\u51c6\u7684\u901a\u7528\u8981\u6c42\u6765\u89c4\u8303\u662f\u4e0d\u591f\u7684\uff0c\u4e3a\u6b64ISO\u7ec4\u7ec7\u9881\u5e03\u4e86ISO13485\uff1a1996\u7248\u6807\u51c6(YY\/T0287 \u548cYY\/T0288)\uff0c\u5bf9\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u63d0\u51fa\u4e86\u4e13\u7528\u8981\u6c42\uff0c\u4e3a\u533b\u7597\u5668\u68b0\u7684\u8d28\u91cf\u8fbe\u5230\u5b89\u5168\u6709\u6548\u8d77\u5230\u4e86\u5f88\u597d\u7684\u4fc3\u8fdb\u4f5c\u7528\u3002\u76ee\u524d\u6267\u884c\u7248\u672c\u662fISO13485:2016\u300a\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u300b\u3002\n<\/div>\n","protected":false},"excerpt":{"rendered":"