1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO TS 11139 KS P ISO TS 11139:2009 2009 12 29 http:/www.kats.go.krKS P ISO TS 11139:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 194) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO TS 11139:2009 .
2、 . ii 1 1 2 .1 8 9 i KS P ISO TS 11139:2009 2006 2 ISO/TS 11139, Sterilization of health care products Vocabulary . . . , , . , , . ii KS P ISO TS 11139:2009 Sterilization of health care productsVocabulary 1 . . 2 2.1 , 2.2 (bioburden) / 2.3 2.4 VIM :1993, Term 6.11 2.5 2.6 KS P ISO TS 11139:2009 2.
3、7 2.8 1 . 2 , . 3 . KS Q ISO 9000 2.9 . KS Q ISO 9000 2.10 , / , . 2.11 D D10 90 % 2.12 , 2.13 2.14 2.15 , 2 KS P ISO TS 11139:2009 2.16 / , , . 2.17 2.18 2.19 . 2.20 2.21 / 2.22 (installation qualification) IQ 2.23 MSDS , , 2.24 , , , , , , , , : , , , , , , , , 3 KS P ISO TS 11139:2009 , . KS P IS
4、O 13485 KS P ISO 13485 GHTF(Global Harmonization Task Force, 2002) . 2.25 , , . 2.26 , , , / . 2.27 (operational qualification) OQ 2.28 2.29 2.30 (performance qualification) PQ 2.31 , 4 KS P ISO TS 11139:2009 2.32 1 . 2 , . KS Q ISO 9000 2.33 (process challenge device) PCD 2.34 . 2.35 . . , , , , ,
5、2.36 KS Q ISO 9000 , , . 2.37 2.38 (recognized culture collection) “ ( )” 2.39 2.40 . 5 KS P ISO TS 11139:2009 2.41 . , , , 2.42 . 2.43 . 2.44 2.45 . ( 2.47) 2.46 (sterility assurance level) SAL SAL 106 103 . , SAL 106 SAL 103 . 2.47 . 0 . (2.46) 2.48 (sterilization load) 2.49 6 KS P ISO TS 11139:20
6、09 ( ), , . , . 2.50 2.51 . 2.52 2.53 2.54 , 2.55 , 7 KS P ISO TS 11139:2009 1 Budapest Treaty on The International Recognition of the Deposit of Microorganisms for the Purposes of Patent Regulation 2 VIM：1993, International vocabulary of basic and general terms in metrology. 2nd ed., BIPM, IEC, IFC
7、C, ISO, IUPAC, IUPAP, OIML Geneva : ISO, 2nd ed. 3 KS Q ISO 9000, 4 KS P ISO 13485, 8 KS P ISO TS 11139:2009 B batch 2.1 bioburden 2.2 biological indicator 2.3C calibration 2.4 change control 2.5 chemical indicator 2.6cleaning 2.7 correction 2.9 corrective action 2.8culture conditions 2.10 D D value
8、 2.11D10 value 2.11 design qualification 2.12 development 2.13 dosimeter 2.14dosimetry system 2.15E environmental control 2.16 establish 2.17 exposure time 2.18F fault 2.19 H health care product(s) 2.20 I inactivation 2.21 installation qualification 2.22 IQ 2.22 M material safety data sheet 2.23 med
9、ical device 2.24microbial characterization 2.25microorganism 2.26O operational qualification 2.27 OQ 2.27 P packaging system 2.28 parametric release 2.29 PCD 2.33 performance qualification 2.30 PQ 2.30 preformed sterile barrier system 2.31 preventive action 2.32 process challenge device 2.33 process
10、 parameter 2.34 process variable 2.35 product 2.36 protective packaging 2.37 R recognized culture collection 2.38 reference microorganism 2.39 requalification 2.40 S SAL 2.46 services 2.41 specify 2.42 sterile 2.43 sterile barrier system 2.44 sterility 2.45 sterility assurance level 2.46 sterilizati
11、on 2.47 sterilization load 2.48 sterilization process 2.49 sterilizing agent 2.50 survivor curve 2.51 T terminal sterilization 2.52 test for sterility 2.53 test of sterility 2.54 V validation 2.55 MSDS 2.23 N non-biological indicator 2.6 9 - 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO TS 11139:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Sterilization of health care products Vocabulary ICS 01.040.11 ; 11.080.01 Korean Agency for Technology and Standards http:/www.kats.go.kr
