GOST ISO 5358-2012 Anaesthetic machines General technical requirements《麻醉机 通用技术要求》.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) (ISO 5358:1992, IDT) 2013 ISO 5358 2012 ISO 53582012 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 . 1919- ISO 53582012 1 2015

2、 . 5 ISO 5358:1992 Anaesthetic machines for use with human ( ). (IDT). 535899. 6 ( ) . , . C, 2013 , ISO 53582012 IV , , . , , . . , , , , , . , . ISO 53582012 1 Anaesthetic machines. General technical requirements 2015-01-01 1 ( ), . , , , , . : a) , ; b) , , ; c) . . 2 : ISO 407:1991 Small medical

3、 gas cylinders Yoke-type valve connections ( . ) ISO 3744:1981 Acoustics Determination of sound power levels of noise sources Engineering methods for free-field conditions over a reflecting plane (. . ) ISO 4135:1979 Anaesthesiology Vocabulary Bilingual edition (. ) ISO 5356-1:1987 Anaesthetic and r

4、espiratory equipment Conical connectors Part 1: Cones and sockets ( . . 1. ) ISO 53582012 2ISO 5356-2:1987 Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ( . . 2. , ) ISO 7396:1987 Non-flammable medical gas pipeline systems ( ) ISO 7767:1988

5、 Oxygen analyzers for monitoring patient breathing mixtures Safety requirements ( , . ) IEC 60601-1:1988 Medical electrical equipment Part 1: General requirements for safety ( . 1. ) 3 , ISO 4135, : 3.1 ( ): . 3.2 : , (), , . 3.3 : , , , , , , . , , - , . 3.4 : , . 3.5 : ( ), . 3.6 : , , . ISO 53582

6、012 33.7 : , ( ) () . 3.8 : , . 3.9 : , . 4 4.1 . . . 4.2 IEC 60601-1: a) 22; b) , 23; c) 24; d) 25; e) 28. 4.3 , , (, ) 1 215 . , , . , - , , . 4.4 , , . ISO 53582012 44.5 (. 13.2.11), , , . 4.6 , . 5 5.1 , , . . 5.2 ( ) 100 . 5.3 , ISO 407, , . , , , ISO 407. 5.4 , , 100 / 20 101,3 , 15 : a) ; b) ; c) . 5.5 . 6 6.1 , , ISO 53582012 5ISO 7396. ( 1) , , . . 6.2 , ( ), 50 / 20 101,3 . 6.3 , ( ), . 7 , 7.1 , . 7.1.1 , . , , 33 % (20 3) . 1 , ISO 53582012 67.1.2 , , . ( ) , . 7.1.3 , , . (. 6.2). , 33 % . 7.1.4 100; , 4.3. . 7.1.5 4 % . 7.1.6 , , , , , , . , . . 7.2 7.2.1 10. 180 300.

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