KS P ISO 11737-1-2012 Sterilization of medical devices－Microbiological methods－Part 1：Determination of population of microorganisms on products《医疗器械的消毒 微生物法 第1部分 产品的微生物群数的判断》.pdf

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7、uct) , , , . KS Q ISO 9000:2007, 3.4.2 3.11 (recognized culture collection) “ ” KS P ISO/TS 11139, 2.38 3.12 (recovery efficiency) 3.13 (sample item portion) SIP( ) KS P ISO 11737 1:2012 4 3.14 (specify) KS P ISO/TS 11139, 2.42 3.15 (validation) , , “ ” “ ” . . KS P ISO/TS 11139, 2.55 4 4.1 4.1.1 .

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10、 SIP SIP ( ) , Gowns( ), ( ) ( ) , SIP . 6 6.1.1 . . a) , b) KS P ISO 11737 1:2012 6 c) , . 6.1.2 6.1.2.1 , , ( ) (4.1.3 ). ( ) . a) b) c) d) 6.1.2.2 , (4.1.3 ). ( ) . a) b) c) 6.1.2.3 , , , , . B . 6.1.3 . (4.1.2 ). 6.1.4 . (4.1.2 ). 6.2 6.2.1 . (： ). 6.2.2 . a) b) KS P ISO 11737 1:2012 7 c) d) e)

11、f) 7 7.1 . 7.2 . a) b) c) d) 8 8.1 , . 8.2 (5.1.2 ). 8.3 (6.2 ). (microflora) . 8.4 , , . 8.5 . . 8.6 , . 8.7 , KS P ISO 13485 . 9 9.1 . (4.1.2 ). , KS P ISO 11737 1:2012 8 . 9.2 . . a) b) . 9.3 (7.2 ) . . . (4.1.3 ). KS P ISO 11737 1:2012 9 A ( ) KS P ISO 11737 . A.1 KS P ISO 11737 . , . , . . A.2

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13、KS P ISO 11737 1:2012 11 . . , . . . KS Q ISO/IEC 17025 4.14 KS P ISO 13485 5.5 , KS P ISO 13485 6.2 . KS P ISO 13485 , KS Q ISO/IEC 17025 5.5 . A.4.3 KS P ISO 13485 , , , , , , . . . , , , , . . . 10-100CFUs . . , - . KS P ISO 13485 7.4 . , KS P ISO 13485 7.4.3 . KS P ISO 13485 7.5 . KS Q ISO/IEC 17025 5.5 5.6 . A.4.4 , , KS P ISO 13485 , , , , ( ). . . . (： , ) (： , , ) KS P ISO 11737 1:2012 12 , , (： , , ) , . . , 2 . a) b) c) . , 1) / ( , ) 2) / / 3) / 4) 5) / / 6) / 7) ( , ) 8) 9) d) 1) 2) , . . A.5 A.5.1 A.5.1.1 . . , . a) KS P ISO 11737 1