GOST ISO 11137-2-2011 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose《保健产品的灭菌 辐射 第2部分 杀菌剂量的确定》.pdf

1、C . 2 (ISO 11137-2:2006, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 11137-22011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 40 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUUZTJ 4 13 2011 . 1279- ISO 11137-22011 1 2013 .5 ISO 11137-2:2006 Sterilization

2、 ofhealth care products Radiation Part 2: Establishing the sterilization dose ( . . 2. ). - .C (IDT). 11137-220086 ()-. , -.- C, 2013 -, II ISO 11137-220111 .12 13 , .13.1 .13.2 .24 , .34.1 .34.2 34.3 , .44.4 .44.5 . . 55 .55.1 55.2 () 65.3 65.4 65.5 76 77 1: 87.1 .87.2 1 c1791,0 .87.3 1 c1791,0 .13

3、7.4 1 - 0,10,9148 2: 158.1 158.2 2 .168.3 2 .189 VDmax: 25 15 209.1 209.2 VDmax25 .219.3 VDmax25 .249.4 VDmax15.259.5 VDmax15 .27III ISO 11137-2201110 2810.1 2810.2 , - 1 2 .2910.3 , VDmax.3111 .3411.1 1 .3411.2 2 .3711.3 VDmax4311.4 1, .4511.5 2, .4611.6 VDmax254748 () - 49IV ISO 11137-22011 ISO 11

4、137 . :- 1. , ;- 2. ;- 3. . ISO 111372000 .V ISO 11137-22011C . 2 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose1 , - , 25 15 () 106. , . / - .2 - . . ( ).ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements fordevelopme

5、nt, validation and routine control of a sterilization process for medical devices ( - . . 1. , - )ISO 11737-1:2003 Sterilization of medical devices Microbiological methods Part 1: Determinationof a population of microorganisms on products ( . . 1. )ISO 11737-2:2003 Sterilisation of medical devices.

6、Microbiological methods. Part 2. Tests of sterilityperformed in the validation of a sterilization process ( . - . 2. , )ISO 13485:2003 Medical devices Quality management systems Requirements for regulatorypurposes ( . . )3 , 3.1 ISO 11137-1, - :3.1.1 (batch): , -,.ISO/S 11139:20063.1.2 (bioburden):

7、/ / - .ISO/S 11139:20061 ISO 11137-22011 201301013.1.3 (falsepositive):, , , , - .3.1.4 (fraction positive): , , .3.1.5 (incremental dose): , , - 2.3.1.6 ( ) (negativetest of sterility): , , .3.1.7 (packaging system): .ISO/S 11139:20063.1.8 ( ) (positivetest of sterility): , , .3.1.9 () sample item

8、portion (SIP): , .3.1.10 (sterile barrier system): , - .3.1.11 () sterility assurance level (SAL): - .ISO/S 11139:2006 , 106 103. - = 106 , , = 103.3.1.12 (sterilization dose audit): , .3.1.13 (verification dose): , = 102 , .3.2 :3.2.1 A ffp FFP.3.2.2 CD* , , 100 , - 2.3.2.3 d* , , , .3.2.4 D* , = 1

9、02 . 3d*, .3.2.5 D* , = 102 , .3.2.6 DD* , 2.3.2.7 DS D10 , DD*.3.2.8 D(Dvalue,D10value) ,90 % .ISO/S 11139:2006 D10 , .3.2.9 (first fraction positive dose) ffp , , , 2 ISO 11137-22011 20 .3.2.10 (First Fraction Positive dose)FFP , 19 20 -, A 3 ffp .3.2.11 (First No Positive dose)FNP , = 102 , DS.3.2.12 VDmax15 - 15 , = 106 .3.2.13 VDmax25 - 25 , = 106 .4 , 4.1 -, (. ISO 11137-1, 8) (. ISO 11137-1, 12). - ; -, (). . , - , , , . , ,