KS P ISO 14161-2012 Sterilization of health care products－Biological indicators－Guidance for the selection use and interpretation of results《医疗保健产品灭菌 生物指示物 选择、使用及检验结果判断指南》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14161 , KS P ISO 14161： 2012 2012 1 2 http： /www.kats.go.krKS P ISO 14161:2012 ： ( ) ( ) () ( ) ： (http：/www.standard.go.kr) ： ：2012 1 2 20120002 ： ： ( 02509 7294) (http：/www.kats.go.kr). 10 5 , . KS P ISO 14161:2012 i . iii . iv 1 1 2 1 3 .2 4 6 5

2、.7 5.1 .7 5.2 8 5.3 9 5.4 9 5.5 10 6 .10 6.1 .10 6.2 .11 7 12 7.1 .12 7.2 .12 7.3 .13 7.4 .14 8 .15 8.1 .15 8.2 15 8.3 15 8.4 15 8.5 .16 8.6 .16 9 .16 9.1 .16 9.2 17 9.3 (PCD).17 10 17 10.1 17 10.2 18 11 18 11.1 .18 11.2 .19 11.3 19 11.4 z 22 KS P ISO 14161:2012 ii 11.5 F(T, z) 24 11.6 (SLR) .24 11.

3、7 (SAL) .24 11.8 25 12 .25 12.1 25 12.2 25 12.3 26 12.4 .26 13 3 .27 13.1 27 13.2 27 13.3 28 14 .28 15 .28 16 .28 A( ) 30 B( ) .36 C( ) D 37 D( ) .51 E( ) z 55 F( ) D 58 G( ) 62 63 KS P ISO 14161:2012 iii . , , . , , . KS P ISO 14161:2012 iv 2009 2 ISO 14161, Sterilization of health care products Bi

4、ological indicators Guidance for the selection, use and interpretation of results , . KS P ISO 14161:2012 , Sterilization of health care products Biological indicatorsGuidance for the selection, use and interpretation of results 1 , , . . 1 ISO 11138 . 2 , . (： ) . . . 2 . . ( ) . KS P ISO 11138 1：

5、2007, 1： KS P ISO 11138 2： 2007, 2： EO KS P ISO 11138 3： 2007, 3： KS P ISO 11138 5： 2009, 5： KS P ISO 11737 1： 2007, 1： KS P ISO 14937： 2012, , , KS P ISO 17665 1： 2008, 1： , KS P ISO 14161:2012 2 ISO 11135 1： 2007, Sterilization of health care products Ethylene oxide Part 1： Requirements for develo

6、pment, validation and routine control of a sterilization process for medical devices ISO 11138 4： 2006, Sterilization of health care products Biological indicators Part 4： Biological indicators for dry heat sterilization processes ISO 18472： 2006, Sterilization of health care products Biological and

7、 chemical indicators Test equipment 3 . 3.1 (accreditation) 1 KS Q ISO/IEC 170113 2 . . 3.2 (aseptic technique) 3.3 (bioburden) / KS P ISO TS 11139, 2.2 3.4 (biological indicator) BI KS P ISO TS 11139, 2.3 3.5 D (D value) D10 (D10value) 90 % KS P ISO TS 11139, 2.11 3.6 (holding time) KS P ISO 14161:

8、2012 3 3.7 (inoculated carrier) 1 KS P ISO 11138 1 2 . 3.8 (installation qualification) IQ KS P ISO TS 11139, 2.22 3.9 (inoculation) . 3.10 (log reduction) LR . 3.11 (operational qualification) OQ KS P ISO TS 11139, 2.27 3.12 (performance qualification) PQ KS P ISO TS 11139, 2.30 3.13 (process chall

9、enge device) PCD KS P ISO TS 11139, 2.33 3.14 (process challenge location) PCL “ ” KS P ISO 14161:2012 4 3.15 (process parameter) . KS P ISO TS 11139, 2.34 3.16 (process variable) , , , , , , KS P ISO TS 11139, 2.35 3.17 (reference microorganism) KS P ISO TS 11139, 2.39 3.18 (resistometer) / 1 KS P

10、ISO 11138 1 3.15 ISO 18472： 2006 3.11 . 2 (BIER) . 3.19 (spore log reduction) SLR N0 NF 3.20 (sterile) . KS P ISO TS 11139, 2.43 3.21 (sterility assurance level) SAL SAL 10 6 10 3 . 10 6 SAL , 10 3 SAL . KS P ISO 14161:2012 5 KS P ISO TS 11139, 2.46 3.22 (sterilization) . 0 . KS P ISO TS 11139, 2.47

11、 3.23 (sterilization cycle development) 3.24 (sterilization cycle validation) , 3.25 (supplier) , , , 1 . 2 “ ” . KS Q ISO 9000, 3.3.6 3.26 (survival kill window) ( ) ( ) KS P ISO 11138 1, 3.18 3.27 3 (third party) 1 KS A ISO/IEC GUIDE 21 2 (“” ) (“” ) . 3.28 (user) KS P ISO 14161:2012 6 1 KS Q ISO

12、90004 2 . “ ” . , . , “ ” . 3.29 z (z value) D 10 KS P ISO 11138 3 ISO 11138 4 4 4.1 . 4.2 / . KS P ISO 134857 . 4.3 / . / , . / , . 4.4 , . , . 4.5 . . 4.6 , . , . . , . 4.7 . . . KS P ISO 14161:2012 7 . . , , . . . 4.8 / . 4.9 . . . , . . 4.10 . 4.11 / . BI 8.2.4 . . 4.12 ISO 11138 . , . . . 4.13

13、, . , / (6.2.2 ). 4.14 / . 5 5.1 5.1.1 ( 8 9 ). / , . 5.1.2 / , , . / / (KS P ISO 134857 KS Q ISO 900122 ). KS P ISO 14161:2012 8 5.1.3 . , KS P ISO 11138 2 (Bacillus subtilis) (Bacillus atrophaeus) . KS P ISO 11138 3 (Geobacillus stearothermophilus) . . 5.1.4 , D , r2 0.8 ( E F ). , , , , (KS P ISO

14、 11138 1 ). 5.1.5 , , . , . 5.1.6 . (7.2.3 ). 10 (11.3.1 ). 5.2 5.2.1 , . , , ( ) . “ ” ( ) , . “ ” . ( KS P ISO 17665 1 ISO 11135 1) . 5.2.2 . . . , , / / . (KS P ISO 11737 1 ). . 5.2.3 . . ( / ) ( A.4 ) . . KS P ISO 14161:2012 9 5.2.4 D z . . ( ) . 5.3 5.3.1 (KS P ISO 11138 1： 2007 B ). , . 5.3.2 . , ( , ), , . 5.3.3 , , , . . 5.3.4 . 5.3.5 ( ) , (KS P ISO 11138 1： 2007 5.2 ). 5.4 a) b) . a) . . . . . ( ) (8.2.4 ). b) .