KS P ISO 11138-3-2012 Sterilization of health care products－Biological indicators－Part 3：Biological indicators for moist heat sterilization processes《保健产品的灭菌 生物指示剂 第3部分 加热水蒸气灭菌用生物指.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11138 3 3： KS P ISO 11138 3:2012 2012 12 27 http:/www.kats.go.krKS P ISO 11138 3:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 11 ：2012 12 27 2012-0767 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11138 3:2012 i ii .

2、iii 1 1 2 1 3 .1 4 .1 5 .1 6 2 7 2 8 2 9 .2 A( ) 4 A.1 .4 A.2 .4 A.3 4 B( ) z .5 8 KS P ISO 11138 3:2012 ii . KS P ISO 11138 3： 2007 . . , , . , , . KS P ISO 11138 3:2012 iii 2006 2 ISO 11138 3, Sterilization of health care products Biological indicators Part 3： Biological indicators for moist heat

3、sterilization processes , . KS P ISO 11138 3:2012 3： Sterilization of health care products Biological indicators Part 3： Biological indicators for moist heat sterilization processes 1 , , , , . . - , . 1 KS P ISO 17665 . 2 . 2 . . ( ) . KS P ISO 11138 1： 2012, 1： ISO 18472, Sterilization of heath ca

4、re products Biological indicators Part 1： General requirements 3 KS P ISO 11138 1 . 4 KS P ISO 11138 1 . 5 5.1 Geobacillus stearothermophilus ( ) . 1 Bacillus stearothermophilus Geobacillus stearothermophilus . 2 Geobacillus stearothermophilus ATCC 7953(NCTC 10007, DSM 22, CIP 52.81), ATCC KS P ISO

5、11138 3:2012 2 12980(NRRL B 4419 ) . 5.2 Geobacillus stearothermophilus Bacillus subtilis ATCC 35021(5230) , . , 121 , Bacillus subtilis ATCC 35021(5230) . 6 KS P ISO 11138 1 . 7 7.1 KS P ISO 11138 1 5.2 B . 7.2 . a) ： 5 b) ： ； , . , / , . c) ： ； , 140 . d) ： 30 . 8 KS P ISO 11138 1 . 9 9.1 KS P ISO

6、 11138 1 6.4 . 9.2 0.110n ( , mL , ). 9.3 0.1105 . 9.4 121 D . / D 121 . 9.5 , , Geobacillus stearothermophilus A 1.5 D121 . D . z 110C 130C KS P ISO 11138 3:2012 3 3 . z , 6C ( B). 9.6 FBIO (KS P ISO 11138 1 3.7). , ISO 11138 . 9.7 D KS P ISO 11138 1 C D . 9.8 D - ( A). 9.9 - KS P ISO 11138 1 E . .

7、 KS P ISO 11138 1 E , D . - . 121C 4.5 13.5 . KS P ISO 11138 3:2012 4 A ( ) A.1 . ISO 18472 . A.2 . A.2 A.2.1 A.2.2 - . 121C0.5C A.2.3 , . A.2.4 . 1： 4.5 kPa1 kPa 2 . 2： 10 . 0 , . 3： . 4： , 10 kPa 1 . 100C 5 . . 5： , . (KS P ISO 11138 1 7.). A.2.5 . A.3 KS P ISO 11138 1 C, D, E . KS P ISO 11138 3:2

8、012 5 B ( ) z B.1 KS P ISO 11138 1 C, D , D . z . z r2 9.5 . B.2 . )()()()(2AnCABnGm= m ： n ： D / G t(log10y) A (t) B (log10y) C (t2) B.1 . B.1 D (min) y ( ) t log10y t2t(log10y) (log10y)2y1t1log10y1(t1)2t1(log10y1) (log10y1)2y2t2log10y2t2)2t2(log10y2) (log10y2)2y3t3log10y3(t3)2t3(log10y3) (log10y3)

9、2yntnlog10yntn)2tn(log10yn) (log10yn)2=niiitA1=niiiyB110log21)(=niiitC =niiiiytG110)(log 2110)(log=niiiyE A B C G E B.3 B.2 . KS P ISO 11138 3:2012 6 B.2 D value (min) y Exposure temperature ( ) t log10y t2t(log10y) (log10y)2y1 2.0 t1 121 log10y1 0.301 0 (t1)2 146 41 t1(log10y1) 36.421 0 (log10y1)2

10、0.090 6y2 1.1 t2 124 log10y2 0.041 4 (t2)2 153 76 t2(log10y2) 5.133 6 (log10y2)2 0.001 7y3 0.4 t3 129 log10y3 0.397 9 (t3)2 166 41 t3(log10y3) 51.329 1 (log10y3)2 0.158 3=31iiitA =3110logiiiyB 231)(=iiitC =3110)(logiiiiytG 25110)(log=iiiyEAssigned variable A 374 B 0.055 5 C 46 658 G 9.774 5 E 0.250

11、6 )()()()(2AnCABnGm= )374()65846()3()5055.0()374()5774.9()3(2=m )876139()974139()0757.20()5323.29(=m 985566.8=m m 0.087 4 B.4 z . z =m11 z =4087.011z 11.441 6 . z 11.4 B.5 z r2 . B.2 E (log10y)2 . B.6 z . B.2 , )3/5055.0()6250.0()3/374()65846()3/5055.0()374()5774.9(2222=r )/()()/()()/()()(2222nBEnAC

12、nBAGr=KS P ISO 11138 3:2012 7 )0001.0()6250.0()3333.62546()65846()0919.6()5774.9(22=r )6249.0()7666.32()5855.2(22=r 6153.89153.82=r r 2 1.000 0 KS P ISO 11138 3:2012 8 1 KS P ISO 14161, , 2 KS P ISO 17665 1, - 1： , 3： 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 11138 3:2012KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Sterilization of health care products Biological indicators Part 3： Biological indicators for moist heat sterilization processes ICS 11.080.01