KS P ISO 11607-1-2007 Packaging for terminally sterilized medical devices-Part 1:Requirements for materials sterile barrier systems and packaging systems《终端无菌医学设备的包装 第1部分 材料、无菌屏障系统.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11607 1 1: , KS P ISO 11607 1: 2007(2012 ) 2007 10 31 http: /www.kats.go.krKS P ISO 11607 1: 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2007 10 31 :2012 12 6 20120679 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11607 1: 2

2、007 i .1 1 1 2 1 3 .1 4 .5 4.1 .6 4.2 6 4.3 .6 4.4 .6 4.5 .6 5 7 5.1 7 5.2 .9 5.3 10 5.4 10 5.5 10 6 11 6.1 .11 6.2 .11 6.3 12 6.4 12 7 .13 A( ) .14 B( ) 17 C( ) 22 23 KS P ISO 11607 1: 2007 (2012 ) 1: , Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile

3、barrier systems, and packaging systems 2006 1 ISO 11607 1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems, and packaging system , . 1 , , . , , . . / . . 2 . . ( ) . KS M ISO 5636 5: 2003, ( ) 5: 3 . 3.1 3.2 KS P ISO 11607 1: 2007 2 IS

4、O/TS 11139: 2006 3.3 . 3.4 3.8 . 3.5 , 3.6 , , . 3.7 , , , , , , , , , , , , , , , , , , . KS P ISO 13485 KS P ISO 13485 (GHTF: Global Harmonization Task Force, 2002) . KS P ISO 11607 1: 2007 3 3.8 3.9 3.10 ISO/TS 11139: 2006 3.11 (3.22) , ISO/TS 11139: 2006 3.12 ISO 9000: 2000 , , , . ISO/TS 11139:

5、 2006 3.13 ISO/TS 11139: 2006 . 3.14 3.15 ( ) 1 . 2 . KS P ISO 11607 1: 2007 4 3 . 4 (International Vocabulary of Basic and General Terms in Metrology, 1993) 3.6 . 3.16 ( ) 1 . 2 . 3 . 4 (International Vocabulary of Basic and General Terms in Metrology, 1993) 3.7 . 3.17 3.18 , . 3.19 3.8 . 3.20 3.21

6、 KS P ISO 11607 1: 2007 5 . ISO/TS 11139: 2006 3.22 ISO/TS 11139: 2006 3.23 / . 3.24 / 3.25 ISO/TS 11139: 2006 3.26 3.27 3.28 ( ) . 3.29 ( ) , , ISO/TS 11139: 2006 . 4 KS P ISO 11607 1: 2007 6 4.1 EN 868 2 EN 868 10 . 4.2 4.2.1 . KS A ISO 9001 KS P ISO 13485 . . 4.2.2 3 . 4.2.3 . 4.3 . . KS A ISO 28

7、59 1 KS M ISO 186 . . 4.4 4.4.1 . B . 4.4.2 . . / . 4.4.3 , 24 (231) (502) % . 4.5 4.5.1 . 4.5.2 . KS P ISO 11607 1: 2007 7 , . 4.5.3 , , , . 4.5.4 , , . 5 5.1 5.1.1 . 5.1.2 (5.1) . 6. . 5.1.3 / , . a) / . b) / . 5.1.4 . a) b) c) d) , e) f) g) h) 5.1.5 , , . . 5.1.6 . a) (5.2 ) b) (toxicological) .

8、ISO 10993 1 . . KS P ISO 11607 1: 2007 8 c) d) e) (5.3 ) f) (pre-sterilization) (post-sterilization) 5.1.7 (wrapping) , , , . a) , . . b) , , , (thickening) / (thinning) . c) ( ) . d) , (lint) . e) , , , . f) , (: pH , ) . g) , . 5.1.8 5.1.1 5.1.7 , . a) . b) . c) . 5.1.9 5.1.1 5.1.7 ( 5.1.8 ) . a)

9、(: , ) , , / . b) , ( / ) . c) ( ) . 1 (reel) . 2 . d) / . 5.1.10 5.1.1 5.1.7 . a) . KS P ISO 11607 1: 2007 9 b) (5.2 ). c) . d) . e) . 1 , . f) . 2 / . g) , , , . 3 EN 868 8 . 5.1.11 5.1.1 5.1.7 ( 5.1.8 ), . a) . b) . , , . c) . 5.1.12 , . , . 5.2 5.2.1 C . . . , . 5.2.2 . 5.2.3 . . , (challenge) .

10、 . . , (edition) ( Sinclair and Tallentire 200241, Tallentire and Sinclair 199840, Scholla et. al 199539, Scholla et al. 200038 ). KS P ISO 11607 1: 2007 10 5.3 5.3.1 . 5.3.2 , . , ISO 17665 1, KS P ISO 11135, ISO 11137( ), ISO 14937, EN 285, EN 550, EN 552, EN 554, EN 1422 EN 14180 . . 5.3.3 . 5.3.

11、4 . 5.3.5 . 5.3.6 , . 5.3.7 . 5.4 . a) . b) , , . c) / / . / , / . 5.5 5.5.1 . 5.5.2 (5.1 ). . KS P ISO 11607 1: 2007 11 a) . b) . 6 6.1 6.1.1 . 6.1.2 . 6.1.3 . 6.1.4 . 6.4.1 . 6.1.5 . ANSI/AAMI ST65: 2000 Hansen et al. 199536 . . 6.1.6 , . . . 6.2 6.2.1 . 6.2.2 . 6.2.3 ( ). a) b) c) d) e) (: , , , ) f) g) h) i) j) , , k) KS P ISO 11607 1: 2007 12 6.2.4 . . (: ) 6.2.5 , (6.2.1, 6.2.3 6.2.4). 6.3 6.3.1 . 6.3.2 . ANSI/AAMI ST65: 2000 Hansen et al. 199536 . 6.3.3 . . 6.3.4 . . 6.3.5 , . 6.4 6.4.1

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