1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) IEC 61010-2-101 2013 - 2-101 (IVD) (IEC 610102101:2002, IDT) IEC 61010-2-1012013 II , 1.092 . 1.2 2009 . , . , , , 1 - ( ) 2 3 , ( 14 2013 . 44-2013) : ( 3166) 004 97 ( 3166) 004 97 BY RU UZ 4 02 2014 . 300- IEC 61010-2-
2、1012013 01 2015 . 5 IEC 61010-2-101: 2002 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment - . 2-101. (IVD). (en). (IDT). , 6 , . () . , , 2014 , IEC 61010-2-1012013 III 1) ()
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6、.1 , : : , IEC 61010-2-1012013 2 , , , (. ). : : h) ; i) . 1.2.2 , : : g) () . , , . 2 IEC 61010-1 : : ISO 14971:2000, Medical devices-Application of risk management to medical devices ( ). 3 IEC 61010-1, : 3.1 : 3.101 (HARM): , , . ISO/IEC 51:1999, 3.3 3.102 (RISK): . ISO/IEC 51:1999, 3.2 3.103 (TO
7、LERABLE RISK): , . ISO/IEC 51:1999, 3.7 : 1 , , , , , , , , . 2 ISO 14971 , . 3.104 (REASONABLY FORESEEABLE MISUSE): , , , . ISO/IEC 51:1999, 3.14 3.105 (PERMANENTLY AFFIXED): , , , , , . 3.106 (MARKING): , , . IEC 61010-2-1012013 3 4 IEC 61010-1, : 4.4.1 : a) : a) , , . : . : : 4.4.2.101 , , , . 5 IEC 61010-1, : 5.1.1 : : IEC 60027. , 1. , , . 101 (. 1).
