GOST R IEC 60601-1-3-2013 Medical electrical equipment Part 1-3 General requirements for basic safety and essential performance Collateral Standard Radiation protection in diagnost.pdf

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1、 60601-1-32013 1-3 . . IEC 60601-1-3:2008Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment(IDT) 1 - ( )2 411 , 3 8 2013 . 1531-4 60601-1-3:2008 . 1-3. - . . - (IEC 60601-1-3:2

2、008 Medical electrical equipment Part 1-3: General requirementsfor basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-rayequipment). - , - 5 1.02012 ( 8). ( 1 ) , -. () . , - - (gost.ru) , 2015 , - - II 60601-1-320131 , .11.1 .11.2 11.3 11.3.1 60601-1 11

3、.3.2 .22 23 24 .84.1 .84.2 .85 , 85.1 85.1.1 .95.1.2 95.2 .95.2.1 95.2.2 105.2.3 .105.2.4 .106 126.1 126.2 .126.2.1 126.2.2 126.3 126.3.1 .126.3.2 126.4 .136.4.1 136.4.2 .136.4.3 136.4.4 136.4.5 .136.5 .146.6 146.7 146.7.1 146.7.2 146.7.3 146.7.4 14III 60601-1-320137 .157.1 157.2 157.3 .157.4 , .167

4、.5 .167.6 168 178.1 178.2 178.3 178.4 178.5 .178.5.1 178.5.2 * 178.5.3 188.5.4 189 - 189.1 189.2 1810 , .1810.1 1810.2 1911 .1912 * .1912.1 1912.2 2012.3 .2012.4 2012.5 .2113 2113.1 2113.2 2113.3 .2113.4 * .2213.5 2213.6 * .22 () .25IV 60601-1-32013 B () Rc16210Rc16220497.26 () 2 60601-1-3 1 .27 ()

5、29 30 31V 60601-1-32013 , - - . , - . . - 60601-1 , , . . , . , , - . . , 60 (ICRP)171), 4. . , . . , - . - . , - . :- ;- , ;- , , ;- ;- , ;- - , . ICRP 33 15, 34 16, 60 17, 73 18, 8521, 87 22 93 23. 60601-1 ( 5) -, ., , , - , .1) .VI 60601-1-32013 1-3 . . Medical electrical equipment. Part 1-3. Gen

6、eral requirements for basic safety and essential performance. Collateralstandard. Radiation protection in diagnostic X-ray equipment 201502011 , 1.1 - , . , , .1.2 ,-,. , ,.- / , . - . , . , ,60601-1, .1.3 1.3.1 60601-160601-1. 60601-1 , , :- 60601-1;- 60601-1-3;- - .1 60601-1-32013 1.3.2 - .2 , - .

7、 . ( ). 60336 . (IEC 60336, Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristicsof focal sports) 60522:1999 . (IEC 60522:1999, Determination of the permanent filtration of X-ray tube assemblies) 60601-1:2005 . 1. - (IEC 60601-1:2005, Medical electricalequipment Pa

8、rt 1: General requirements for basic safety and essential performance)/ 60788:2004 . (IEC/TR 60788:2004, Medicalelectrical equipment Glossary of defined terms) 497 , (ISO 497, Guide to choice of series of preferred numbersand of series containing more rounded values of preferred numbers)3 , 60601-1, / 60788 . . 31 .3.1 (ACCESSIBLE SURFACE): , , .3.2 (ADDED FILTER): , - .3.3

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