KS P 6131-2009 Hospital steam sterilizers《医疗用大型蒸气杀菌机》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 6131 KS P 6131 :2009 2009 12 21 http:/www.kats.go.krKS P 6131:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 2 25 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P 6131:2009 i ii .1 1 1 1.1 .1 1.2 .1 1.3 .1 2

2、 2 3 .2 4 6 4.1 6 4.2 , , 8 4.3 8 4.4 9 4.5 11 4.6 .11 4.7 .11 5 11 5.1 12 5.2 , , 12 5.3 12 5.4 13 5.5 14 5.6 22 5.7 .27 A() 28 A.1 .28 A.2 .30 A.3 30 A.4 .30 B() 33 C() 37 KS P 6131:2009 ii . KS P 6131：2004 . . , , . , , . KS P 6131:2009 Hospital steam sterilizers 2008 ANSI/AAMI ST8, Hospital stea

3、m sterilizer , . 1 1.1 56.63 L(2 cubic feetft 3 ) . , , , , , , . . 1.2 56.63 L(2 ft 3 ) , , , , ( ), . , . . . . 1.3 , / 1.2 . , , , , . . 56.63 L(2 ft 3 ) KS P 6130, ANSI/AAMI ST79 . ANSI/AAMI ST79 KS P 6131:2009 2 . 2 . . ( ) . 2.1 AMERICAN SOCIETY OF MECHANICAL ENGINEERS. Boiler and pressure ves

4、sel code. New York: ASME, 2007(with current amendments) 2.2 ASSOCIATION FOR THE ADVANCEMENT MEDICAL INSTRUMENTATION. Sterilization of healthcare productsBiological indicatorPart 3：Biological indicators for moist heat sterilization processes. ANSI/AAMI/ISO 111383：2006. Arlington(VA): AAMI, 2006. Amer

5、ican National Standard 2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of health care procuctsChemical indicatorsPart 5：Class 2 indicators for Bowie and Dick air removal test sheets and packs. ANSI/AAMI/ISO 111405：2007. Arlington(VA): AAMI, 2007. American National stand

6、ard 2.4 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of health care procuctsMoist heatPart 1： Requirments for the development, validation and routine control of a sterilization process for medical devices. ANSI/AAMI/ISO 176651：2006. Arlington (VA): 2006 2.5 EUROPEAN COMM

7、ITTEE FOR STANDARDIZATION. STERILIZATIONSteam sterilizersLarge sterilizers. EN285. Current edition. Brussels: CEN 2.6 NATIONAL FIRE PROTECTION ASSOCIATION. National electrical code. NFPA 70: 2005. Quincy (MA): NFPA, 2005 2.7 UNDERWRITERS LABORATORIES. Electrical equipment for measurement, control, a

8、nd laboratory usePart 1：General requirements. UL 61010-1. Current edition. Northbrook(IL): UL 2( 2.8) 1( 2.7) . 2.8 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Electrical equipment for laboratory use Part 2：Particular requirements for autoclaves using steam for the treatment of medical materials and

9、for laoratory processes. IEC 61010-2-040. Current edition. Geneva: IEC 3 . 3.1 KS P 6131:2009 3 3.2 (QSR) “ , ” . , . 21 CFR 820.72(b)(1) 3.3 3.4 , . 3.5 3.6 3.7 3.8 , , ( ) . 1 . 2 . 132 135 (270 275 ). 3 . ( .) 132 135 (270 275 ). 3.9 , , , () KS P 6131:2009 4 121 123 (250 254 ) 132 134 (270 275 )

10、. 3.10 (BI) 90 % 3.11 D 90 % . 3.12 , . 3.13 F F Z . 3.14 F 0 10 Z 121.1 (250 ) F 0 . 3.15 . ANSI/AAMI ST79 3.16 . , . 3.17 3.18 , , . . KS P 6131:2009 5 3.19 ( PCD .) 100 g(0.22 pound) . 3.20 , psig . psi 3.21 204.7 kPa(15 psig) ASME PEA . 3.22 3.23 PCD 3.24 psi . psia( ), psig( ) kPa() 1 . 1 psia

11、psig kPa 29.8 15.1 205.5 41.9 27.2 288.9 45.4 30.7 313.0 53.3 38.6 367.5 3.25 , 3.26 KS P 6131:2009 6 3.27 3.28 3.29 SAL 1 10 n . 2 10 6 ( 10 7 , 10 8 ) 100 1 . 10 6 (異形) (, ) . ANSI/AAMI ST67 3.30 ( ) 3.31 , 3.32 3.33 , . 3.34 Z D 10 Z , D Z . 4 4.1 4.1.1 4.1.1.1 KS P 6131:2009 7 , . a) b) c) d) e)

12、 f) g) h) ( ) 4.1.1.2 , . , . (4.1.2 ) . 4.1.2 ( ) . a) b) c) . , , . 1 EN285 . 2 . , ANSI/AAMI/ISO 176651 AAMI TIR34 . d) , e) . , , , /, , , . KS P 6131:2009 8 4.1.3 , . . . 4.2 , , 4.2.1 ( ) . 204.7 kPa(15 psig) ASME PEA . . , ASME PEA . 4.2.2 ASME PEA . 4.2.3 IEC 610101 IEC 610102040 , (National

13、 Electrical code) . 4.2.4 4.2.4.1 ( ) ASME PEA . 4.2.4.2 () . 4.2.5 0.3 99.97 % . . 4.3 KS P 6131:2009 9 4.3.1 . . . 4.3.2 , IEC 610101 IEC 610102040 . 4.3.3 , . . 4.4 4.4.1 , . a) b) c) d) , . , . 4.1.2 c). 4.4.2 4.4.2.1 , . 4.4.2.2 , . KS P 6131:2009 10 4.4.2.3 , 1 (2) . 4.4.2.4 , 5 ( 10) 1 (2 ) .

14、 , 132 (270 ) 1 (2 ) 127 137 (260 280) . , . 4.4.2.5 , 3 ( 6 ) 0 ( 0 ) . 5 ( 10 ) 1 . (a) (b) 1 (c) . 4.4.3 4.4.2.5 5.4.2.5 . 4.4.4 5 % (4.4.2.5 ). 4.4.5 4.4.5.1 , . . 3 % . 6.9 kPa(1 psi) . 13.8 kPa(1 psi) . 5 . 4.4.5.2 . . 3 % , 6.9 kPa(1 psi) . 13.8 kPa (2 psig) . 4.4.6 KS P 6131:2009 11 . a) b) c) d) e) . . . B 4.5 5.5 , 10 6 . 5.5 . 4.6 (5.6.1) (5.6.2) . . (3.8 ). 4.6.1 ( ) ( ) 5.6.1 5.6.1.4 . 4.6.2 ( ) 5.6.2 , 1 mmHg (0.13 kPa)(0.019 psia) . 4.7 . . 5 4. . , . 4. (：4.2.3 5.2.3 ). KS P 6131:2009 12 KGMP(3.2 ) . . 4.