1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15883 1 1： , , KS P ISO 15883 1:2012 2012 1 2 http:/www.kats.go.krKS P ISO 15883 1:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2012 1 2 2012-0002 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 15883 1:2012 i . iii iv 1 1 2 1
2、3 .2 4 .9 4.1 .9 4.2 .10 4.3 .11 4.4 .12 4.5 .12 4.6 12 5 13 5.1 , , / 13 5.2 .14 5.3 .14 5.4 / .15 5.5 17 5.6 .18 5.7 18 5.8 .19 5.9 .19 5.10 , , 20 5.11 20 5.12 21 5.13 .22 5.14 .23 5.15 .23 5.16 23 5.17 ( ) .24 5.18 25 5.19 26 5.20 27 5.21 .27 5.22 .27 5.23 28 5.24 28 5.25 .29 5.26 WD 29 5.27 WD
3、30 5.28 .30 KS P ISO 15883 1:2012 ii 5.29 .31 6 .31 6.1 .31 6.2 34 6.3 , .35 6.4 .37 6.5 39 6.6 WD .41 6.7 42 6.8 .43 6.9 .46 6.10 .47 6.11 .49 6.12 .49 6.13 .49 7 50 8 50 8.1 .50 8.2 WD .51 8.3 WD .52 9 , 53 9.1 .53 9.2 .53 10 WD 53 A( ) .55 B( ) A0 .59 B.1 .59 B.2 A 59 B.3 “ ” 59 B.4 WD .60 B.5 61
4、 B.6 (microbial challenge) .61 C( ) 63 C.1 .63 C.2 OPA 64 C.3 (biuret) 65 D( ) .68 D.1 .68 D.2 .68 69 KS P ISO 15883 1:2012 iii . , , . , , . KS P ISO 15883 1:2012 iv 2006 1 ISO 15883 1, Washer-disinfectors Part 1 ： General requirements, terms and definitions and tests , . , . ISO 15883 . , , . ISO
5、15883 , , , , , . . , ISO 15883 . , , , . IEC 61010 2-045 . ( ) , . . . , . ISO/TS 15883 5 . TC 198 . . a) / . b) ISO 15883 EU EFTA . KS P ISO 15883 1:2012 1： , , Washer-disinfectors Part 1： General requirements, terms and definitions and tests 1 , , , (WD) . . , , / . . , . . “ ” , (： EN 285) . (TS
6、E) ( ) . , . WD . WD WD . A . 2 . . ( ) . KS B ISO 228 1： 2007, , KS P ISO 15883 1:2012 2 KS C IEC 60584 1： 2003, 1： KS C IEC 60751： 2003, KS C IEC 80416 1： 2011, 1： KS I ISO 14644 3： 2006, 3： KS Q ISO 10012： 2004, KS S ISO 7000： 2004, ISO 14971： 2007, Medical devices Application of risk management
7、to medical devices ISO/TS 15883 5： 2005, Washer-disinfectors Part 5： Test soils and methods for demonstrating cleaning efficacy IEC 60417 DB 12M： 2002, Graphical symbols for use on equipment 12-month subscription to online database comprising all graphical symbols published in IEC 60417 IEC 61010 2-
8、045： 2000, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-045 ： Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields European Pharmacopeia, European Directorate for the Quality of Medicines
9、 Council of Europe, Strasbourg, France United States Pharmacopeia, USP Pharmacopeia, Rockville, USA 3 . 3.1 A0z 10 K 80 ( ) B 3.2 (automatic controller) 3.3 (bedpan washer-disinfector) , , 3.4 (bioburden) / 3.5 (calibration) , EN 285： 1996, 3.5 KS P ISO 15883 1:2012 3 3.6 (calorifier) 3.7 (chamber)
10、 ( ) . 3.8 (chemical disinfection) . 3.9 (cleaning) 3.10 (continuous process machine) 3.11 (critical process variables) . . 3.12 (cycle complete) 3.13 (cycle control recorder) 3.14 D 1 log 90 % 3.15 (dead volume) 3.16 (disinfection) KS P ISO 15883 1:2012 4 3.17 (disinfection temperature) 3.18 (disin
11、fection temperature band) (3.17) 3.19 (disinfection time) (： , ) 3.20 (door) 3.21 (double-ended washer-disinfector) 3.22 (endoscope washer-disinfector) 3.23 (fail safe) 3.24 (fault) 3.25 (fluid) , 3.26 (flushing) / . . 3.27 (free draining) . 3.28 (holding time) KS P ISO 15883 1:2012 5 3.29 (human wa
12、ste) , , , , , 3.30 (human waste container) 3.31 (installation qualification) IQ KS P ISO TS 11139： 2009, 2.20 3.32 (instrument washer-disinfector) , , , , , , 3.33 (load) , , 3.34 (loading door) 3.35 (medical device) , , , , , , , , , , , , , , , , , , , , , , KS P ISO 13485： 2007, 3.7 KS P ISO 158
13、83 1:2012 6 3.36 (icrobial reduction factor) 10 . ( 10) 3.37 (monitoring) 3.38 (normal operation) 3.39 (operating cycle) 3.40 (operating pressure) 3.41 (operational qualification) OQ KS P ISO TS 11139： 2009, 2.24 3.42 (override) 3.43 (performance qualification) PQ KS P ISO TS 11139： 2009, 2.26 . 3.4
14、4 (process chemical) , , , . KS P ISO 15883 1:2012 7 3.45 (process variable) , , , 3.46 (process verification recorder) 3.47 (recorder) , 3.48 (re-qualification) 3.49 (rinsing) 3.50 (routine test) 3.51 (steam generator) (： ) , . 3.52 (tank) , . 3.53 (test microorganism) . “ (The International Recogn
15、ition of the Deposit of Microorganisms for the Purpose of Patent and Regulation)” . 3.54 (test soil) KS P ISO 15883 1:2012 8 3.55 (thermal disinfection) 3.56 (type test) . 3.57 (unloading door) (3.21) 3.58 (validation) , , KS P ISO TS 11139： 2009, 2.50 3.59 (verification) KS Q ISO 9000： 2007, 3.8.4
16、3.60 (viable microorganism) 3.61 (warning pipe) , . 3.62 (washer-disinfector) WD , , , , 3.63 (washing) 3.64 (works test) KS P ISO 15883 1:2012 9 3.65 z 10 (K) 4 4.1 4.1.1 6. . ISO 15883 WD WD (“ ” 6.1.2 .) , 3 WD (“ ” 6.1.3 .) . 4.1.2 ISO 15883 WD , , , . , ( ), , , , ( , , ), , , . 4.1.3 , . a) (
17、) b) c) d) ( ) , . 4.1.4 , 8.1 b) 6) 8.1 b) 5) WD 8.1 b) 2) . 4.1.5 , , . . , , . ( , A0 ) ISO 15883 . ISO 15883 . . 4.1.6 WD . , . KS P ISO 15883 1:2012 10 , . , . 4.1.7 (6.5.2 6.5.4 ). 4.1.8 WD WD, , . 4.1.9 WD , ( ) . . 4.1.10 . (： ) . 4.2 4.2.1 4.2.1.1 6.10 ISO 15883 . (6.10.2) ISO/TS 15883 5 ( 24 39 ) . 1 ISO/TS 15883 5 . 2 6.10.3 C . 3
