1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11737 1 1： KS P ISO 11737 1:2012 2012 12 27 http:/www.kats.go.krKS P ISO 11737 1:2012 : ( ) ( ) () ( ) : (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 11737 1:2012 i ii . i
2、ii 1 1 2 1 3 .1 4 .4 4.1 .4 4.2 (management responsibility)4 4.3 (product) 4 4.4 , (Mesurement, analysis and improvement Control of nonconforming product)5 5 .5 5.1 .5 5.2 (SIP).5 6 5 6.2 6 7 7 8 .7 9 7 9.1 .7 9.2 8 9.3 .8 A( ) .9 B( ) 22 C( ) .31 34 KS P ISO 11737 1:2012 ii . , , . , , . KS P ISO 1
3、1737 1:2012 iii 2006 2 ISO 11737 1, Sterilization of medical devices Microbiological methods Part 1： Determination of population of microorganisms on products , . KS P ISO 11737 1:2012 1： Sterilization of medical devices Microbiological methods Part 1： Determination of population of microorganisms o
4、n products 1 , , , . . 1 protozoan . 2 , , Creutzfeldt-Jabob encephalopathies . . 3 (ISO 9001 ) . , . 2 . . ( ) . KS P ISO 13485, KS Q ISO 10012, KS Q ISO/IEC 17025, ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation and servicing 3 3.1 (biobu
5、rden) / KS P ISO 11737 1:2012 2 KS P ISO/TS 11139, 2.2 3.2 (correction) (3.4) . KS Q ISO 9000:2007, 3.6.6 3.3 (correction factor) 3.4 (correction action) ( ) 1 . 2 , . 3 . KS P ISO/TS 11139, 2.8 3.5 (culture conditions) , , , . KS P ISO/TS 11139, 2.10 3.6 (establish) KS P ISO/TS 11139, 2.17 3.7 (med
6、ical device) , , , , , , , , , , , , , , , , , ( ) KS P ISO 11737 1:2012 3 , . KS P ISO 13485 the Global Harmonization Task Force(GHTF 2002) . KS P ISO 13485 3.8 (microbial charaterization) , (colony), , . KS P ISO/TS 11139, 2.25 3.9 (preventive action) 1 . 2 , . KS Q ISO 9000:2007, 3.6.4 3.10 (prod
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 .
8、4.1.2 KS P ISO 11737 , . (4.2.1 ). KS P ISO 13485 KS Q ISO/IEC 17025 . 4.1.3 , , . , , . 4.1.4 ( ) , 4.2 (management responsibility) 4.2.1 KS P ISO 11737 . KS P ISO 13485 KS Q ISO/IEC 17025 , 4.2.2 KS P ISO 11737 , . 4.2.3 . 4.3 (product realization) 4.3.1 . KS P ISO 13485 KS Q ISO/IEC 17025 . 4.3.2
9、 KS P ISO 13485, KS Q ISO/IEC 17025 KS Q ISO 10012 KS P ISO 11737 . KS P ISO 11737 1:2012 5 4.3.3 . 4.4 , (Measurement, analysis and improvement Control of nonconforming product) , . KS P ISO 13485 KS Q ISO/IEC 17025 . 5 5.1 5.1.1 . 5.1.2 , (4.1.2 ). . 5.1.3 . . 5.2 (SIP) , SIP . , SIP , . , SIP . 1
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
12、, . . A.3 . A.4 . . . 3 . A.4.1 KS P ISO 13485 ( ) . / , . . , . KS P ISO 11737 1:2012 10 , ( , ) , . , ; . . . . , , , . , . KS P ISO 13485 4.2.3, 4.2.4, KS Q ISO/IEC 17025 4.3, 4.13 . KS X ISO/IEC ISO 90003 A.4.2 KS P ISO 13485 , , , , , , , . , . . , , . , . , . . . , . , (KS Q ISO/IEC 17025). .
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
