GOST ISO 11138-1-2012 Sterilization of health care products Biological indicators Part 1 Technical requirements《医疗卫生产品的灭菌 生物学指标 第1部分 技术要求》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 1 (ISO 11138-1:1994, IDT) 2013 ISO 11138-1 2012 ISO 11138-12012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 ) : ( 3166) 00497 ( 3166) 00497 AZ AM BY KG MD - RU TJ KZ TM UZ 4 19 2012 . 1921- IS 1113

2、8-12012 1 2015 . 5 ISO 11138-1:1994 Sterilization of health care products Biological indicators Part 1: General requirements ( . . 1. ). C (IDT). 11138-12000. . 6 ( ) . , . . C, 2013 , . ISO 11138-12012 III . . . . / . - , . , . . . , . , . ISO 11138-12012 1 1 Sterilization of health care products.

3、Biological indicators. Part 1. Technical requirements 20150101 1 1.1 , , . ISO 11138-2 ISO 11138-3. , , , , , . 2 : _ ISO 11138-12012 2ISO 9002:1994 Quality systems - Model for quality assurance in production, installation and servicing ( . , ) ISO 11138-2:1994 Sterilization of health care products.

4、 Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization ( . . 2. ) ISO 11138-3:1995 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization ( . . 3. ) 3 : 3.1 (biological indicator BI): , () . 3.2 (carrie

5、r): , -. 3.3 (primary pack): , , (). 3.4 (secondary pack): , . ISO 11138-12012 33.5 (inoculated carrier): , -. 3.6 - (test organism): , . 3.7 - (viable test organism count): - , . 3.8 (inactivation): - , / . 3.9 (culture conditions): , / -, , . 3.10 (recognized culture collection): , . 3.11 () D; (D

6、 value): , - 10 . 3.12 (survivor curve): ( ) . 3.13 (process challenge device): , () . ISO 11138-12012 4 1 , , (). 2 . . 3 . 3.14 (colony-forming unit CFU): , . 3.15 (self-contained biological indicator): , , -. 3.16 (survivalkill window): , ( ) ( ). 3.17 (nominal population): . . ISO 11138-12012 53

7、.18 (resistometer): , - . 4 , 4.1 4.1.1 , , ISO 9002. 4.1.2 . , -, . 4.1.3 , (, ), - , . , , . 4.2 - 4.2.1 - . 4.2.2 - , , . ISO 11138-12012 64.2.3 - , . 4.2.4 - : ) ; ) . , -, . - . 4.3 - 4.3.1 , -, . - ISO 11138-2 ISO 11138-3. 4.3.2 , . . , , . 4.3.3 - , ISO 11138-12012 7 - , . 4.3.4 - , , - , , : a) -; b) , -, ; c) ( , - ); d) , ; e) ; f) ; g) ; h) , , ; i) . 4.3.5 . . 4.3.6 -