1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11607 2 2: , KS P ISO 11607 2: 2007(2012 ) 2007 10 31 http: /www.kats.go.krKS P ISO 11607 2: 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2007 10 31 :2012 12 6 20120679 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11607 2: 2
2、007 i .1 1 1 2 1 3 .1 4 .4 4.1 4 4.2 .4 4.3 .4 4.4 .5 5 5 5.1 .5 5.2 (IQ: installation qualification) 5 5.3 (OQ: operational qualification)6 5.4 (PQ: performance qualification)7 5.5 .7 5.6 .8 5.7 .8 6 8 7 8 8 9 A( ) 10 11 KS P ISO 11607 2: 2007 (2012 ) 2: , Packaging for terminally sterilized medica
3、l devices Part 2: Validation requirements for forming, sealing and assembly processes 2006 1 ISO 11607 2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes , . 1 . , , . , , . . / . 2 . . ( ) . KS P ISO 11607 1, 1: , 3 . 3
4、.1 , 3.2 KS P ISO 11607 2: 2007 2 IQ (installation qualification) ISO/TS 11139: 2006 3.3 , , . 3.4 OQ (operational qualification) ISO/TS 11139: 2006 3.5 ISO/TS 11139: 2006 3.6 PQ (performance qualification) ISO/TS 11139: 2006 3.7 , ISO/TS 11139: 2006 3.8 3.9 ISO 9000: 2000 , , , . ISO/TS 11139: 2006
5、 KS P ISO 11607 2: 2007 3 3.10 ISO/TS 11139: 2006 3.11 ( ) 1 . 2 . 3 . 4 (International Vocabulary of Basic and General Terms in Metrology, 1993) 3.6 . 3.12 ( ) 1 . 2 . 3 . 4 (International Vocabulary of Basic and General Terms in Metrology, 1993) 3.7 . 3.13 3.14 ISO/TS 11139: 2006 3.15 KS P ISO 116
6、07 2: 2007 4 / . 3.16 ( ) , , ISO/TS 11139: 2006 . 4 4.1 4.1.1 . KS A ISO 9001 KS P ISO 13485 . . 4.1.2 3 . 4.1.3 . 4.2 . . KS A ISO 2859 1 KS M ISO 186 . . 4.3 4.3.1 . KS P ISO 11607 1 B . 4.3.2 . . / . KS P ISO 11607 2: 2007 5 4.3.3 , 24 (231) (502) % . 4.4 4.4.1 . 4.4.2 . , . 4.4.3 , , , IQ, OQ,
7、PQ . 4.4.4 , , . 5 5.1 5.1.1 . . , / / / 5.1.2 , . 5.1.3 , ( A ). 5.1.4 . . 5.1.5 . . . 5.2 (IQ: installation qualification) KS P ISO 11607 2: 2007 6 5.2.1 . . , , , , , , 5.2.2 . 5.2.3 . 5.2.4 , . 5.2.5 , , , , . . 5.2.6 . 5.2.7 (PLC: programmable logic controller), . , . , , , ( ). 5.3 (OQ: operat
8、ional qualification) 5.3.1 . 5.3.2 , . . a) / . / . . . b) . KS P ISO 11607 2: 2007 7 - (open-seal) EN 868 5: 1999 4.3.2 . c) . 5.4 (PQ: performance qualification) 5.4.1 . 5.4.2 . / 5.4.3 . , , , ( ) . 5.4.4 . . , , , . 5.4.5 , . 5.4.6 . 5.4.7 . 5.5 5.5.1 . 5.5.2 , . KS P ISO 11607 2: 2007 8 5.6 5.6
9、.1 . 5.6.2 . 5.7 5.7.1 , , . 5.7.2 , , , . . / 5.7.3 . , . 5.7.4 . 6 6.1 . 6.2 . DIN 58953 7 DIN 58953 8 . 6.3 . , , , . 7 6. , KS P ISO 11607 1 5.1.10 5.1.11 (: , , , , ). EN 868 8, DIN 58953 9 AAMI/ANSI ST33 . EN 13795 1 ANSI/AAMI ST65KS P ISO 11607 2: 2007 9 . 8 8.1 5. 6. . 8.2 “ (sterile fluid p
10、ath)” . 1 KS P ISO 11607 1 . . 2 , . KS P ISO 11607 2: 2007 10 A ( ) , . , . . . (process window) . ( , ). . . / ( ) / ( / ) / . KS P ISO 11607 2: 2007 11 2:, 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ KS P ISO 11607 2: 2007 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Packaging for terminally sterilized medical devicesPart 2:Validation requirements for forming, sealing and assembly procsses ICS 11.080.30 Korean Agency for Technology and Standards http:/www.kats.go.kr