Transcription of 식품의약품안전처, IEC 60601-1 3.1판 도입
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식품의약품안전처, IEC 60601-1 3.1판 도입
, IEC 60601 -1 . (IEC 60601 -1) 3 . ' . 2015 12 31 . ( : 2015 12 31 , 2 : 2016 1 1. / 1 : 2016 7 1 ). IEC 60601 -1 3 .. 1. IEC 60601 -1 3 . A.. 38 . ( : 126 88 ). B.. (Body-Worn) (8 ) (3 ). C.. 2.. A.. , (2017 12 31 ) 3 .. * : , (' ), (' ), (' ). B. 3 ( ) 2 .. IEC 60601 -1 3 .. , 3 . 2017 12 31 3 .. [ ]. - / . - . - / . - (GMP ). - (CRO). - .. 1. IEC 60601 -1 : 2.
식품의약품안전처, iec 60601-1 3.1판 도입 전자의료기기에 대한 전기·기계적 안전에 관한 국제규격(iec 60601-1)이 3판에서 3.1판으로 개정됨에 따라
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IEC 60601, 1 Risk Management, 1 Risk Management Guidance, New standard for medical beds - EN 60601, 60601, IEC 60601-1: Changes from 2nd, Intertek, Major IEC 60601-1 3rd Ed changes, Major IEC 60601-1 3rd Ed. changes, 12 INTERNATIONAL STANDARD NORME INTERNATIONALE, 02 INTERNATIONAL STANDARD NORME INTERNATIONALE, IEC 62353: Standards for the Safety and