KS P ISO 13408-5-2010 Aseptic processing of healthcare products－Part 5：Sterilization in place《保健产品的无菌加工 第5部分 现场消毒》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 134085 5：SIP(sterilization in place) KS P ISO 134085 :2010 2010 12 30 http:/www.kats.go.krKS P ISO 134085:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 134085

2、:2010 i ii .1 1 1 2 1 3 .2 4 3 4.1 .3 4.2 4 4.3 .4 4.4 4 5 .4 5.1 4 5.2 .5 5.3 .5 6 .6 6.1 6 6.2 6 6.3 7 7 SIP 7 7.1 7 7.2 7 8 .7 8.1 7 8.2 .8 8.3 .8 8.4 .8 8.5 .9 8.6 .10 8.7 .10 9 11 9.1 SIP 11 9.2 .11 9.3 SIP 11 9.4 .11 9.5 .12 10 .12 A() .13 A.1 .13 A.2 .13 A.3 14 A.4 14 A.5 .14 15 KS P ISO 1340

3、85:2010 ii . . , , . , , . KS P ISO 134085:2010 5：SIP(sterilization in place) Aseptic processing of healthcare products Part 5：Sterilization in place 2006 1 ISO 134085, Aseptic processing of health care productsPart 5：Sterilization in place , . 1 1.1 SIP(sterilization in place) , , . SIP . A . 1.2 .

4、 1.3 . 1.4 GMP / . 1.5 , , . . KS P ISO 224421, KS P ISO 224422 KS P ISO 224423 . 2 . . ( ) . KS P ISO 134085:2010 2 KS P ISO 11138( ), KS P ISO 11140( ), KS P ISO 134081, 1： KS P ISO 134084, 4：CIP(clean-in-place) KS P ISO 176651, 1： , ISO 14161, Sterilization of health care productsBiological indic

5、atorsGuidance for the selection, use and interpretation of results ISO 14937, Sterilization of health care productsGeneral requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO/IEC 90003, Softwa

6、re engineeringGuidelines for the application of ISO 9001:2000 to computer software 3 KS P ISO 134081 . 3.1 (dead leg) 3.2 (design qualification) , KS P ISO TS 11139：2009, 2.12 3.3 (material safety data sheet) MSDS , KS P ISO TS 11139：2009, 2.23 3.4 (process parameter) . KS P ISO TS 11139：2009, 2.34

7、3.5 (process variable) , , , , , KS P ISO 134085:2010 3 KS P ISO TS 11139：2009, 2.35 3.6 SIP (sterilization in place) “ (steam in place) KS P ISO 134081 19. SIP . “SIP” “ ” “ ” . “ ” “ SIP” . 3.7 (sterility assurance level) SAL 1 SAL 10 6 10 3 . , SAL 10 6 SAL 10 3 . KS P ISO TS 11139：2009, 2.46 2 S

8、IP . 3.8 (sterilization process) KS P ISO TS 11139：2009, 2.49 3.9 (sterilizing agent) KS P ISO TS 11139：2009, 2.50 4 4.1 4.1.1 KS P ISO 134081 . 4.1.2 , , SIP . 4.1.3 . 4.1.4 , , KS P ISO 134085:2010 4 . 4.2 4.2.1 . 4.2.2 . 4.3 , , SIP SIP . , . 4.4 4.4.1 . 4.4.2 . 5 5.1 5.1.1 SIP . a) b) c) , , d)

9、/ e) f) g) h) i) j) 5.1.2 . 5.1.3 . 5.1.4 SIP . . 5.1.5 . . KS P ISO 134085:2010 5 . 5.2 . . 5.3 5.3.1 SIP 5.3.1.1 SIP , ( , ) . . a) b) c) , , d) e) ( ) f) g) h) , i) ( , , , , , , ) j) SIP ( ) . / . , ( ) . 5.3.1.2 . a) ( “ ” ) b) c) , . d) e) f) / KS P ISO 134085:2010 6 g) 5.3.2 SIP 5.3.2.1 SIP .

10、 . a) b) c) d) e) f) g) 5.3.2.2 . a) “ ” b) c) , , d) e) ： , SIP SIP . f) / 5.3.3 , . . 6 6.1 6.1.1 , . 6.1.2 . 6.2 6.2.1 . KS P ISO 134085:2010 7 6.2.2 . 6.3 6.3.1 . 6.3.2 . 7 SIP 7.1 7.1.1 5.2 . SIP . 7.1.2 . a) b) c) , , d) e) ( , , ) f) , 7.1.3 . 7.2 7.2.1 . SIP . 7.2.2 . 7.2.3 . 7.2.4 . . 8 8.1

11、 . . , , KS P ISO 134085:2010 8 . . 8.2 SIP . , , , , . 8.3 8.3.1 SIP SIP . 8.3.2 8.3.2.1 . a) . b) . c) . 8.3.2.2 , , ( ) . . 8.3.2.3 ISO/IEC 90003 . 8.4 8.4.1 SIP . 8.4.2 . . a) b) c) , d) , e) 8.4.3 / . . KS P ISO 134085:2010 9 8.4.4 ( , , , ) SIP . 8.4.5 SIP (, ) SIP . 8.4.6 . SIP . 8.5 8.5.1 8.

12、5.1.1 . 8.5.1.2 (ISO 14937 ). 8.5.1.3 / . . . ISO 14937 . 8.5.1.4 SIP SIP . . 8.5.1.5 SIP . 8.5.1.6 . KS P ISO 111381, KS P ISO 11138 (ISO 14937 ). . SIP . 8.5.1.7 KS P ISO 111381, KS P ISO 11138 (ISO 14937 ). . SIP . 8.5.1.8 SIP . SIP . 8.5.1.9 (8.5.1.8 ) SIP KS P ISO 134085:2010 10 SIP . , , , (ISO 14937 ). 8.5.2 . a) SAL 10 6 1 . . . . b) , (lethal action) . (D-, ) ( . , (ISO 14161 ). c) . d) / . 2 , , , . 8.6 8.6.1 , , . . 8.6.2 . SIP . 8.6.3 . , . 8.6.4 . 8.7 8.7.1 SIP . 8.7.2 SIP . KS P ISO 134085:2010 11 . 8.7.3 . 9 9.1 SIP SIP . SIP . 9.2 . . a) b) c) d) ,