1、 60601-2-43 2013 2-43 IEC 60601-2-43:2010 Medical electrical equipment Part 2-43: Particular requirements for basic safety and essential performance of the X-ray equipment for interventional procedures (IDT) 2014 60601-2-432013 II 1 - ( ) , 4 2 411 , 3 - 08 2013 . 1487-. 4 60601-2-43:2010 . 2-43. -
2、(IEC 60601-2-43:2010 Medical electrical equipment Part 2-43: Particular requirements for basic safety and essential performance of the X-ray equipment for interventional procedures) - , - 5 60601-2-432013 III 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 -, - 60601-2-432013 IV 201.1 , . 1 201.2
3、 3 201.3 3 201.4 . 4 201.5 . 5 201.6 . 5 201.7 , . 5 201.8 , 9 201.9 , . 9 201.10 10 201.11 . 10 201.12 . 12 201.13 . 14 201.14 (S) . 14 201.15 14 201.16 15 201.17 () . 15 202 : . 15 203 15 () 25 BB () . 31 () () 60601-2-43 34 () . 37 . 38 39 60601-2-432013 V - . - . , . . , . : ; ; . - . - , . 6060
4、1-2-432013 1 2-43 Medical electrical equipment Part 2-43: Particular requirements for basic safety and essential performance of the X-ray equipment for interventional procedures 20150101 201.1 , 1 1), : 201.1.1 * : , , -, - , - . : - ; - ; - , -; - ; - . 1 , - , - , . 2 - , . -. 3 - ( ) . 2. 1 60601
5、-1:2005 . 1. 60601-2-432013 2 , , , , , . - , . . 4.2 . 201.1.2 : : , - 201.3.203; , . 201.1.3 : , 2 201.2 . 60601-1-2 60601-1-3 , 202 203 - . 60601-1-8 60601-1-10 - . 60601-1 . 201.1.4 : 60601 , , - - . -. 60601-1 -. . - 201 (, 201.1 1 ). 20, (, 202.4 - 4 60601-1-2, 203.4 4 60601-1-3 .). -: - , - ;
6、 - , ; - , , , . , , , , 201.101. , 3.1 3.139 60601-2-432013 3 201.3.201. , ., ), bb) . , , , , , 20x, x (, 202 60601-1-2, 203 60601-1-3 .). , - . , - -, , ; - - , , , - . 201.2 2 , : . : 60601-1-2:2007 . 1-2. - . . - . (IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements
7、 for basic safety and essential performance Collateral standard: Electro-magnetic compatibility Requirements and tests) 60601-1-3:2008 . 1-3. - . . (IEC 60601-1-3:2008, Medical electrical equip-ment Part 1-3: General requirements for basic safety and essential performance Collateral standard: Radiat
8、ion protection in diagnostic X-ray equipment) : 60580 . (IEC 60580, Medical electrical equipment Dose area product meters) 60601-2-54:2009 . 2-54. - (IEC 60601-2-54:2009, Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment
9、 for radiography and radios-copy) / 60788:2004 . (IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms) 62220-1:2003 . . 1. (IEC 62220-1:2003, Medical electrical equipment Part 1: Determination of the detective quantum efficiency) 201.3 60601-1, : 1 , , -. 2 , , - . 201.3.201 * (IMAGE DISPLAY DE-LAY):
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