GOST R IEC 62274-2013 Medical electrical equipment Safety of radiotherapy record and verify systems《医疗电气设备 放射线透视记录和验证系统安全》.pdf

1、 62274 2013 IEC 62274:2005 Medical electrical equipment Safety of radiotherapy record and verify systems (IDT) 2014 622742013 II 1 - ( ) , 4 2 TK 411 , 3 08 2013 . 1437-. 4 62274:2005 - . (IEC 62274:2005 Medical electrical equipment Safety of radiotherapy record and verify systems). - , - 5 1.02012

2、( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 , - 622742013 III () ( ) , , , - . - -, . . - , - . 622742013 1 Medical electrical equipment Safety of radiotherapy record and verify systems 2015 01 01 1 , 1.1 , - () . , : ), ; , - ; b) ; c) ; d) : 1) , ; 2) , ; 3) , - . . . , . 1.2 . ; . . - (. 1.3.1 -).

3、 , . , - , . 1.3 1.3.1 - - , - , , -. - , . 622742013 2 1.3.2 60601-1-4 (. 4.1). 60601-1-4 , - , - . 60691-1-6 . 1.3.3 61217 , 61217, . 1.3.4 . . , . , , . , , , - , . 2 . . - ( ). 60601-1 . 1. (IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential per

4、formance) 60601-1-2 . 1-2. -. . (IEC 60601-1-2, Medical elec-trical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compati-bility Requirements and tests) 60601-1-4:1996 . 1. -. 4. (IEC 60601-1-4:1996 Medical electrical equipment Part 1-4: General requirement

5、s for safety Collateral standard: Programmable electrical medical systems) 60601-2-29 . 2-29. - (IEC 60601-2-29, Medical electrical equipment Part 2-29: Particular requirements for the safety of radiotherapy simulators) / 60788 . (IECTR60788, Medical electrical equipment Glossary of defined terms) 6

6、0950-1 . . 1. (IEC 60950-1, Information technology equipment Safety Part 1: General require-ments) 61000 ( ) (IEC 61000 (all parts) electromagnetic compatibility (EMC) 61217 . , (IEC 61217, Radiotherapy equipment Coordinates, movements and scales) - , 1 , - , , . -, , - (). -, , , , , . , , , , - .

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8、) 18 12 b) 19 20 12 d) 21 13 22 A.1.4 23 A.3 . 622742013 4 6 6.1 . . (, : ), , , . -. 6.2 , , . : 03 2005, 03/04/2005 (/), 2005/04/03 (/). : 03/04/05, 03/04/2005, 03 05. , 24- , , 12- , , - (a.m p.m.). , , . , , . . - c: 2,05 ; 1 33; 1:43:15 (:). , , , , . -. 6.3 - 61217. , . - , . . , - . 6.4 . , , . . -