{"id":37264,"date":"2019-07-25T11:57:17","date_gmt":"2019-07-25T09:57:17","guid":{"rendered":"https:\/\/cryomedpro.com\/articles\/cryomed-has-successfully-achieved-medical-certification\/"},"modified":"2019-10-26T10:06:52","modified_gmt":"2019-10-26T08:06:52","slug":"cryomed-has-successfully-achieved-medical-certification","status":"publish","type":"post","link":"https:\/\/cryomedpro.com\/zh-hans\/articles\/cryomed-has-successfully-achieved-medical-certification\/","title":{"rendered":"Cryomed \u5df2\u6210\u529f\u83b7\u5f97\u533b\u7597\u8ba4\u8bc1"},"content":{"rendered":"

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Cryomed \u5f88\u81ea\u8c6a\u5730\u5206\u4eab\u6211\u4eec\u7684\u6700\u65b0\u6d88\u606f – \u6211\u4eec\u5df2\u6210\u4e3a\u4e16\u754c\u4e0a\u552f\u4e00\u7b26\u5408 EN ISO 13485:2016 \u6807\u51c6\u7684\u51b7\u51bb\u6cbb\u7597\u8bbe\u5907\u5236\u9020\u5546\u3002\u6b64\u5916\uff0c\u6211\u4eec\u8fd8\u83b7\u5f97\u4e86\u7b26\u5408 EC \u6307\u4ee4 93\/42\/EEC Annex II \u89c4\u5b9a\u7684\u8bc1\u4e66\u3002\u800c\u4e14\uff0c\u53d1\u884c\u673a\u6784\u662f\u8be5\u5730\u533a\u6700\u6709\u58f0\u8a89\u7684\u673a\u6784\u4e4b\u4e00 – T\u00dcV Rheinland \u3002<\/p>\n

\"Cryomed

Cryomed \u7b26\u5408 EN ISO 13485:2016 \u8981\u6c42\u7684\u8bc1\u4e66<\/p><\/div>\n

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\"Cryomed

Cryomed \u7b26\u5408 EC \u6307\u4ee4 93\/42\/EEC Annex II \u89c4\u5b9a\u7684\u8bc1\u4e66<\/p><\/div>\n

\u5728\u6211\u4eec\u7684\u5de5\u5382\uff0c\u6211\u4eec\u5efa\u7acb\u5e76\u5b9e\u65bd\u4e86\u4e00\u5957\u5b8c\u6574\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u6db5\u76d6\u4e86\u533b\u7597\u51b7\u51bb\u6cbb\u7597\u8bbe\u5907\u7684\u5236\u9020\u3001\u5206\u9500\u3001\u5b89\u88c5\u548c\u670d\u52a1\u3002<\/p>\n

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\u4f9b\u60a8\u53c2\u8003\uff1a<\/strong><\/p>\n

ISO 13485:2016 \u89c4\u5b9a\u4e86\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u8981\u6c42\uff0c\u5373\u7ec4\u7ec7\u9700\u8981\u8bc1\u660e\u5176\u6709\u80fd\u529b\u63d0\u4f9b\u59cb\u7ec8\u6ee1\u8db3\u5ba2\u6237\u548c\u9002\u7528\u6cd5\u89c4\u8981\u6c42\u7684\u533b\u7597\u8bbe\u5907\u548c\u76f8\u5173\u670d\u52a1\u3002<\/p>\n

Annex II\uff1a\u5168\u9762\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb – \u6b64\u7b26\u5408\u6027\u8bc4\u4f30\u5305\u62ec\u5bf9\u5236\u9020\u5546\u7684\u6574\u4e2a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u5ba1\u67e5\uff0c\u5305\u62ec\u8bbe\u8ba1\u3001\u5236\u9020\u548c\u6700\u7ec8\u68c0\u9a8c\u3002<\/p>\n

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