GOST ISO 11737-1-2012 Sterilization of medical devices Microbiological methods Part 1 Estimation of population of microorganisms on products《医疗器械灭菌 微生物法 第1部分 产品上微生物数量的估计》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) ISO 11737-1 2012 1 (ISO 11737-1:1995, IDT) ISO 11737-1 2012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 24 2012 . 41-2012) : ( 3166) 00497 ( 3166) 00497 AZ BY KZ KG MD - RU TJ TM UZ UA AM 4 19 2012 . 1922- IS 1173

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4、iological methods. Part 1. Estimation of population of microorganisms on products 2015-01-01 1 1.1 () , . . . . . 1.2 , . (ISO 9001 ISO 9002), , . , . 2 : ISO 11134:1994 Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterization ( . . )

5、ISO 11135:1994 Medical devices Validation and routine control of ethylene oxide sterilization ( . ) ISO 11137:1995 Sterilization of health care products. Requirements for validation and routine control. Radiation sterilization ( . . ) ISO 11138-2:1994 Sterilization of health care products. Biologica

6、l indicators. Part 2. Biological indicators for ethylene oxide sterilization ( . . 2. ) ISO 9001:1994 Quality systems Model for quality assurance in design, development, production, installation and servicing ( . , , , ) ISO 9002:1994 Quality systems Model for quality assurance in production, instal

7、lation and servicing ( . , ) 3 : 3.1 (bioburden): , , / . ISO 11737-1 2012 2 3.2 (bioburden estimate): , , , , , . 3.3 (characterization): . , , , . 3.4 (correction factor): , , , . 3.5 (culture conditions): , , . 3.6 : , , , , , , : - , , , ; - , , , ; - , ; - , , , . 3.7 (presterilization count): , . 3.8 () (product): , . 3.9 (recovery efficiency): . 3.10 (revalidation): . 3.11 (sample item portion SIP): , . 3.12 (validation): , , , , ; . 3.13 (viable count): , . . 4 4.1 4.1.1 , . ISO 9001. 4.1.2 , . 4.1.3 .