KS P 6130-2009 Table-top steam sterilizers《医疗用小型蒸气杀菌机》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 6130 KS P 6130 :2009 2009 12 21 http:/www.kats.go.krKS P 6130:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2000 3 27 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P 6130:2009 i ii 1 1 1.1 .1 1.2 .1 1.3 .1 2 1

2、3 .2 4 5 4.1 5 4.2 , , 6 4.3 7 4.4 7 4.5 9 4.6 .9 4.7 12 4.8 .12 5 12 5.1 12 5.2 , , 12 5.3 13 5.4 13 5.5 15 5.6 .21 5.7 23 5.8 .26 A() 27 A.1 .27 A.2 .28 A.3 28 A.4 .28 B() 33 C() 35 D().39 KS P 6130:2009 ii 2003 ANSI/AAMI ST55, Table-top steam sterilizers , . . KS P 6130：2004 . . , , . , , . KS P

3、6130:2009 Table-top steam sterilizers 1 1.1 , 2 cu ft(56 L) . , , , , , , . . 1.2 , 2 cu ft , , . , . . . . 1.3 , , / . ( 2 cu ft ) (KS P 6131, ANSI/AAMI ST8：2008) . 2 . . ( ) . 2.1 AMERICAN SOCIETY OF MECHANICAL ENGINEERS. Boiler and pressure vessel code. New York: ASME, 2001 KS P 6130:2009 2 2.2 A

4、SSOCIATION FOR THE ADVANCEMENT MEDICAL INSTRUMENTATION. Sterilization of healthcare productsBiological indicatorPart 1：General requirements. ANSI/AAMI ST59: 1999. Arlington (VA): AAMI, 1999. American National Standard 2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of h

5、ealth care procuctsChemical indicatorsPart 3：Biological indicators for moist heat sterilization. ANSI/AAMI ST19: 1999. Arlington (VA): AAMI, 1999. American National Standard 2.4 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Sterilization of health care procuctsRequirement for validaito

6、n and routine controlIndustrial moist heat sterilization. 2ed. ANSI/AAMI/ISO 11134：1993. Arlington (VA): AAMI, 1993. American National Standard 2.5 NATIONAL FIRE PROTECTION ASSOCIATION. National electrical code. ANSI/NFPA 70: 2002. Quincy(MA): NFPA, 2002. American National Standard 2.6 UNDERWRITERS

7、LABORATORIES. Electrical equipment for laboratory usePart 1：General requirements. UL 61010A-1. Northbrook (IL): UL, 2002 2.7 UNDERWRITERS LABORATORIES. Electrical equipment for laboratory usePart 2：Particular requirements for autoclaves using steam for the treatment of medical materials and for laor

8、atory processes. UL 61010A-2-041. Northbrook (IL): UL, 2002 3 . 3.1 3.2 () 3.3 3.4 , (QSR) “ , ” . , . 21 CFR 820.72(b)(1) KS P 6130:2009 3 3.5 , . 3.6 3.7 3.8 3.9 , , 1 . 132 135 (270 275 ) . . 2 . . ( .) 132 135 (270 275 ). 3.10 , , , () . 121 123 (250 254 ) 132 134 (270 275 ). 3.11 D 90 % 3.12 .

9、, . KS P 6130:2009 4 3.13 () . . 3.14 3.15 , , . ( ). 3.16 15 psig ASME PEA 3.17 3.18 PCD 3.19 . . 3.20 3.21 3.22 SAL KS P 6130:2009 5 1 10 n . 2 10 6 100 1 . 10 6 (異形) (, ) . 3.23 3.24 , 3.25 3.26 , . 4 4.1 4.1.1 4.1.1.1 . a) b) c) d) e) f) g) ( ) 4.1.1.2 . , . (4.1.2 ) . 4.1.2 KS P 6130:2009 6 . a

10、) b) c) . . d) . , , , , . e) , , , , /, , , . 4.1.3 , . . . 4.2 , , 4.2.1 . 15 psig ASME PEA (2.1 ) . . 15 psig 2.25 . , ASME PEA . 4.2.2 ASME PEA . 4.2.3 UL 61010A1 UL 61010A-2-041 , (2.6 2.7 ). (National Electrical Code) (2.5 ). 4.2.4 4.2.4.1 KS P 6130:2009 7 ( ) ASME PEA (2.1 ). . 4.2.4.2 () . 4

11、.2.5 , 0.3 99.97 % . . 4.2.6 . (a) (b) . 4.1.2 e) . 4.3 4.3.1 . . . ASME PEA (2.1 ). 4.3.2 , UL 61010A1 UL 61010A2041 (2.6 2.7 ). 4.3.3 , . . 4.4 KS P 6130:2009 8 4.4.1 4.4.1.1 . . . . 4.4.1.2 . . 4.4.1.3 , 1 2 . 4.4.1.4 , 5 10 1 (2 ) . , 132 (270 ) 1 2 127 137 (260 280 ) . , ( B ). 4.4.2 3 0 (5.4.2

12、 ). 5 ( 10 ) 1 2 . , 1 , . 4.4.3 4.4.2 5.4.2 . 4.4.4 . 4.4.2 , . 5 % (4.4.2 B ). 4.4.5 KS P 6130:2009 9 4.4.5.1 , . 3 % . 1 psig . 4 . 4.4.5.2 . . 3 % , 1 psig . 5 . 4.4.6 . 4.4.7 . 4.3.3 . 4.4.8 . a) b) c) d) e) . . C 4.5 5.5 , (BIs) . 1.5 D 121 10 6 . , (ANSI/AAMI/ISO 11134：1993 ), 5.5 . 4.6 KS P

13、6130:2009 10 (5.6.1) (5.6.2) . . 4.6.1 ( ) ( ) 5.6.1 5.6.1.4 . 4.6.2 ( ) 5.6.2 , 1 mmHg . 4.6.3 ( ) 5.6.3 , 3 (6 ) ( 1 ). 1.5 (3 ) , 2 4 . 1 (Spirax Sarco, Inc. ) (in Hg Vac) (psia) () (hf) (BTU/Ib) (hfg) (BTU/Ib) (hg) (BTU/Ib) (Vg) (ft 3 /Ib) 27.96 1 101.7 69.5 1 032.9 1 102.4 333.0 25.91 2 126.1 9

14、3.9 1 019.7 1 113.6 173.5 23.87 3 141.5 109.3 1 011.3 1 120.6 118.6 21.83 4 153.0 120.8 1 004.9 1 125.7 90.52 19.79 5 162.3 130.1 999.7 1 129.8 73.42 17.75 6 170.1 137.8 995.4 1 133.2 61.89 15.70 7 176.9 144.6 991.5 1 136.1 53.57 13.66 8 182.9 150.7 987.9 1 138.6 47.26 11.62 9 188.3 156.2 984.7 1 14

15、0.9 42.32 9.58 10 193.2 161.1 981.9 1 143.0 38.37 7.54 11 197.8 165.7 979.2 1 144.9 35.09 5.49 12 202.0 169.9 976.7 1 146.6 32.35 3.45 13 205.9 173.9 974.3 1 148.2 30.01 1.41 14 209.6 177.6 972.2 1 149.8 28.00 0 14.7 212.0 180.2 970.6 1 150.8 26.80 1 15.7 215.4 183.6 968.4 1 152.0 25.20 2 16.7 218.5

16、 186.8 966.4 1 153.2 23.80 3 17.7 221.5 189.8 964.5 1 154.3 22.50 4 18.7 224.5 192.7 962.6 1 155.3 21.40 KS P 6130:2009 11 1 (Spirax Sarco, Inc. )() (in Hg Vac) (psia) () (hf) (BTU/Ib) (hfg) (BTU/Ib) (hg) (BTU/Ib) (Vg) (ft 3 /Ib) 5 19.7 227.4 195.5 960.8 1 156.3 20.40 6 20.7 230.0 198.1 959.2 1 157.

17、3 19.40 7 21.7 232.4 200.6 957.6 1 158.2 18.60 8 22.7 234.8 203.1 956.0 1 159.1 17.90 9 23.7 237.1 205.5 954.5 1 160.0 17.20 10 24.7 239.4 207.9 952.9 1 160.8 16.50 11 25.7 241.6 210.1 951.5 1 161.6 15.90 12 26.7 243.7 212.3 950.1 1 162.3 15.30 13 27.7 245.8 214.4 948.6 1 163.0 14.80 14 28.7 247.9 216.4 947.3 1 163.7 14.30 15 29.7 249.8 218.4 946.0 1 164.4 13.90 16 30.7 251.7 220.3 944.8 1 165.1 13.40 17 31.7 253.6 253.6 943.5 1 165.7 13.00 18 32.7 255.4 255.4 942.4 1 166.4 12.70 19 33.7 257.2 257.2 94