GOST ISO 9918-2012 Capnometers for use with humans Requirements《人用二氧化碳检测仪 要求》.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) (ISO 9918:1993, IDT) 2013 ISO 9918 2012 ISO 99182012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ AM BY KZ KG MD RU TJ UZ UA 4 19 2012 . 1930- ISO 99182012 1 2015

2、 . 5 ISO 9918:1993 Capnometers for use with humans. Requirements ( . ). (IDT). 991899. 6 ( ) . , . C, 2013 , ISO 99182012 VI ISO 991893 . , SC3 ISO 121 . , IEC 60601-1 IEC 60601-1. , , , . , , . L . , . ISO 99182012 1 Capnometers for use with humans. Requirements 2015-01-01 . 1.1 IEC 60601-1. 1.3 IE

3、C 60601-1 ( ) . 1 . 1.1 , 1.3.6. , , . , () . , . . 1.2 : ISO 3744:1981 Acoustics Determination of sound power levels of noise sources Engineering methods for free-field conditions over a reflecting plane (. . ) ISO 99182012 2ISO 5356-1:1987 Anaesthetic and respiratory equipment Conical connectors.

4、Part 1: Cones and sockets ( . . 1. ) ISO 5356-2:1987 Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ( . . 2. , ) ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals ( . 1. ) IEC 60065:1985 Safety of ma

5、in operated electronic and related apparatus for household and similar general use General requirements and test methods ( , . ) IEC 60651:1979 Sound level meters ( . ) IEC 60601-1:1988 Medical electrical equipment Part 1: General requirements for safety ( . 1. ) IEC 61000-4-2:1995 Electromagnetic c

6、ompatibility (EMC) Part 4-2: Testing and measuring techniques Electrostatic discharge immunity test ( (). 4-2. . ) 1.3 2 , : ISO 99182012 31.3.1 : , , . 1.3.2 : , , ( ) , . 1.3.3 : , . 1.3.4 : , ( ) . . 1.3.5 : , : a) () ; b) , ( ) . 1.3.6 : , . , ( ), . 1.3.7 (2): . , (%) () ( . .). ISO 99182012 41

7、3.8 : , . 1.3.9 , : . 1.3.10 (), : , . 1.3.11 : 2 , 10 % 2 ( 1). 1.3.12 : . 1.3.13 : , . 1.3.14 (): , . 1.3.15 : . 1.3.16 (): , . 1.3.17 (): , . 1.3.18 : , , . 1.3.19 : . ISO 99182012 5 (%) (), ( . .) ( ). 1.3.20 : , , , , . 1.3.21 ( ): ( ) , . 1.3.22 : , 2 10 % 90 % , , 1 ( ). 1.3.23 : , , , . 1.3

8、24 : . 1.3.25 : , . 1.3.26 : , . 1.3.27 : ( 1). ISO 99182012 61.3.28 : () , () . 1.3.29 ( ): , . 1.4 3 : 3.1.1 . 3.1.2 , . 3.10 , , , . 1 ( ) ISO 99182012 71.5 4 , : 4.12 , , , , . , , . 1.6 5 . 1.7 , , 6 , : a) 6 : - , , 1,0 ( ) 1 215 . . b) 6.1 d) : , : - ; - ; ISO 99182012 8- 14 D1 . c) 6.1 f) : , . d) 6.1 q)

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