GOST 31515 3-2012 Non-invasive sphygmomanometers (measuring devices of arterial pressure) Part 3 Supplementary requirements for electro-mechanical blood pressure measuring systems《.pdf

1、 , (C) INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 31515.3 2012 (EN 1060-3:1997) ( ) (EN 1060-3:1997, MOD) 2013 31515.3 - 2012 , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ BY KZ KG RU TJ UZ 4 1 2012 . 623- 31515.3 2

2、012 (EN 1060-3:1997) 1 2015 . 5 EN 1060-3:1997 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems ( . 3. ), . (MOD). 51959.32002 ( 1060-3 97) II 31515.3 - 2012 6 ( ) . , . C, 2013 , III 31515.3 - 2012 ( ) . , , , . IV 31515.3 - 2

3、012 ( ) 3 Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems 2015-01-01 1 , , ( ), . , , () , . , . 1 31515.3 - 2012 1. 30324.30. 31515.1. , ( 1, 7.3, 7.5.3, 7.11). 2 : 30324.095 (IEC 601

4、-188) . 1. 30324.1.22012 (IEC 60601-1-2:2001) . 1-2. . . 30324.302002 ( 60601-2-30:1995) . 2. 31515.12012 (EN 1060-1:1996) ( ) . 1. 31515.22012 (EN 1060-2:1996) ( ) . 2. , 1 , , . (), 2 31515.3 - 2012 () . , , , , . 3 31515.1, 30324.0 30324.30, : 3.1 () : , ( ) ; , . , , . 3.2 : , : a) , () ; b) ; c

5、) ; d) ( ). 3.3 : , . 3.4 : , , , , 3 31515.3 - 2012 (), . , , , . , , . , . 3.5 : , 0 . . . 3.6 : () . , . 4 4 31515.1. 5 (). 5 31515.1. 6 6 31515.1. 7 7.1 4 31515.3 - 2012 , , , , . 7.2 7.1.1 31515.1. 7.3 7.3.1 : a) , , 56.7 30324.30; b) , 8.2.1, ; c) , . 8.2.1 8.3.1. 7.3.2 : a) , , 49.3 49.101 30

6、324.30; b) , (9.2), . 5 31515.3 - 2012 8.2.2 8.3.2 ( ) 8.2.3 8.3.3 ( ); c) , , 7.3.2, b). 8.2.4 ( ) 8.2.5 ( ). 7.4 7.4.1 6 . ./ (0,8 /). , , 4 . ./ (0,5 /). 8.4. 7.4.2 , ( ) 2 . ./ 5 . ./ ( 0,3 0,7 /) , . , , 2 5 . ./ ( 0,3 0, 7 /). . 8.5. 7.4.3 6 31515.3 - 2012 260 15 . . ( 34,7 2 ) 10 . 150 5 . . ( 20,0 0,7 ) 5 . 8.6. 7.4.4 . 0 . . (0 ). , , , 1 . . (0,1 ). 8.7 8.8. 7.5 7.5.1 , , 24 5 24 50 85 % ( ). (. 7.1.1 31515.1) 8.1 31515.1 24 5 24 50 . 7 31515.3 - 2012 . , 31515.1, . 7.5.2 7.1.2.2 31515.1. , , , 7.1.2.2 31515.1. 8.9. 7.5.3 , : a) () ,