GOST ISO 8185-2012 Humidifiers for medical use Technical requirements and test methods《医用加湿器 技术要求和试验方法》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARTIZATION, METROLOGY AND CERTIFICATION (ISC) (ISO 8185:1997, IDT) 2013 ISO 8185 2012 ISO 81852012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .). : ( 3166) 004-97 ( 3166) 004-97 AZ AM BY KZ KG MD - RU TJ UZ UA 4 19 2012 . 1934- ISO 81852012 1

2、 2015 . ISO 81852012 III5 ISO 8185:1997 Humidifiers for medical use. General requirements for humidification systems ( . ). . 818599. (IDT). 6 ( ) . , . C, 2013 , ISO 81852012 VII , IEC 601, 1.3 IEC 601-1 ( ) . . , , () () . () , , , , , . ( ), , . , , , . S. ISO 81852012 1 Humidifiers for medical u

3、se. Technical requirements and test methods 2015-01-01 1 1.1 1.3.107, . , : , ( ), , ( ). IEC 60601-1 , , , , . , ( ), , . - (), , , , , , , . , . ISO 81852012 2 . 1.2 : ISO 5356-1:1987 Anaesthetic and respiratory equipment. Conical connectors. Part 1. Cones and sockets. ( . . .) IEC 60801-2:1991 El

4、ectromagnetic compatibility of technical means. Electrostatic discharge immunity. Technical requirements and test methods. ( . . .) IEC 60601-1:1988 Medical electrical equipment. Part 1. General safety requirements. ( . 1. .) IEC 60601-2-19:1990 Medical electrical equipment. Part 2. Particular requi

5、rements for safety of baby incubators. ( . 2. ) IEC 60601-1-2:1993 Medical electrical equipment. Part 1. General requirements for safety. 2. Collateral standard: electromagnetic compatibility. Requirements and tests. ( . 1. . 2. . ) ISO 8835-2:1993 Inhalational anaesthesia systems. Part 2. Anaesthet

6、ic circle breathing systems. ( . 2. ) ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals. Part 1. Visual alarm signals. ( . 1. ) ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals. Part 2. Auditory alarm signals. ( . 2. ) ISO 10651-1:1993 Lung ventilators for medical use. Par

7、t 1. Requirements. ( . 1. ) ISO 4135:1995 Anaesthesiology. Vocabulary. (. ) ISO 10524:1995 Pressure regulators and pressure regulators with flow-metering devices for medical gas systems. ( ( ) ) ISO 81852012 3IEC 60079-3:1990 Electrical apparatus for explosive gas atmospheres. Part 3. Spark-test app

8、aratus for intrinsically-safe circuits. ( . 3. ) IEC 60079-4:1975 Electrical apparatus for explosive gas atmospheres. Part 4. Method of test for ignition temperature. ( . 4. ) 1.3 ISO 4135, 2 : 1.3.101 : , , () . 1.3.102 : , . . 1.3.103 : , , . 1.3.104 ( ): , . . 1.3.105 : , . 1.3.106 : , , ( ), . 1

9、.3.107 : , , . . 1.3.108 : , . ISO 81852012 4 1.3.109 : ( ), 37 , 101,3 (760 . .) , (BTPS)1. 1.3.110 : , . . 1.3.111 : , . 1.3.112 : . 1.3.113 : , , , , . 1.3.113 : , , . 1.3.115 : , , , , . , ( , ), . 1.3.116 : , %. 1.3.117 : , . . 1.3.118 : , , . _ 1 BTPS (37 ), , . ISO 81852012 5 , , (. N). 1.4 3 : 3.6 h) - ; 3.6 l) , , : - ; - ; - . 3.6 m) ( ), . 1.5 4 : 4.5 ) , b) (. 1) (23 2), RH = (50 5) % 860 1060 . f) : , . g) , . ( ) . h) , 50 ( N). 1.6 5 . 1.7 6 : 6.1 ) : 1) , ; ISO 81852012 6 2) ,