KS M ISO 16038-2008 Rubber condoms－Guidance on the use of KS M ISO 4074 in the quality management of natural rubber latex condoms《橡胶避孕套 关于天然橡胶胶乳避孕套质量管理的KS M ISO 4047的使用指南》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS M ISO 16038 KS M ISO 4074 KS M ISO 16038:2008 2008 12 29 http:/www.kats.go.krKS M ISO 16038:2008 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2008 12 29 2008-00000980 ： ： ( 025097301) (http:/www.kats.go.kr). 10 5 , . 0980 KS M ISO 16038:2008 KS M I

2、SO 4074 Rubber condoms Guidance on the use of KS M ISO 4074 in the quality management of natural rubber latex condoms 2005 1 ISO 16038, Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms , . 1 KS M ISO 4074 , , . , , . 2 . . ( ) . KS A ISO 31 0,

3、0： KS M ISO 4074, KS P ISO 14155 1, 1： KS P ISO 14155 2, 2： KS Q ISO 2859 1, 1： (AQL) KS Q ISO 9000, 3 KS M ISO 4074 KS Q ISO 9000 . 4 4.1 1 , . KS M ISO 16038:2008 2 ( ) , . (master file) . KS Q ISO 9000 GMP . , KS Q ISO 9001 GMP . , , ( , , , ), , , . , / . / , , , ( ) , (leaching) . , , , , , , .

4、 KS M ISO 4074 , , , , . , . . 4.2 , , . . , . KS P ISO 14155 1 KS P ISO 14155 2 . . ISO 14971 . KS M ISO 16037 . 4.3 4.3.1 ISO 14971 . ( ). , , . KS M ISO 4074 . . . KS M ISO 16038:2008 3 4.3.2 . . . . EN 455 3 ASTM D 5712 99 . . ASTM D 6499 03 ELISA . 4.3.3 , , , . . KS P ISO 10993 1 . 5 5.1 . . (

5、Good Manufacturing Practices) KS Q ISO 9001, KS P ISO 13485 . . . . 5.2 ( ) KS M ISO 4074 . . , KS Q ISO 2859 1 . KS M ISO 4074 . , KS Q ISO 2859 1 . 3 KS M ISO 4074 . , . . . . KS M ISO 16038:2008 4 3 . , , KS M ISO 4074 B . 5.3 KS M ISO 4074 . KS M ISO 4074 , KS A ISO 31 0 B . 6 , . , . KS P ISO 1

6、3485 . , . , , , , , KS M ISO 4074 . , . . . WHO 5 . , , , . , , . , . (batch) , . , . , , . WHO . 7 , 3 . 3 ( KS Q ISO 9001) KS Q ISO/IEC 17025 KS M ISO 16038:2008 5 . KS M ISO 4074 KS Q ISO 2859 1 ( 0.25 AQL) , . 3 KS Q ISO 2859 1 . 3 . 8 KS M ISO 4074 8.1 , . . . . . . . . , . 8.2 . . . “ (extra

7、strong)” , . . , . KS M ISO 4074 , 0.060 mm . 8.3 “ ” . . KS M ISO 4074 . , . (8.7 ). . 8.4 . , , . , . KS M ISO 16038:2008 6 , . . , . . , , . , . KS M ISO 4074 7. . (5230) . KS M ISO 4074 7. . , . , . . . . . , . KS M ISO 4074 K( .) . . , . (KS M ISO 4074 ) . 3 , . , KS M ISO 4074 5 . KS M ISO 407

8、4 K . , ISO/TC 157 (working group) . KS M ISO 4074 K . 30 83 kJ/mol (Arrhenius shift factor) . (pV) 1 . . pV KS M ISO 16038:2008 7 . 30 2 pV 50 kPa L . 2 3 . . . 30 . . 30 . 2 30 2 2.2 kPa 2.3 kPa . 2 pV 50 kPa L , 22 L . 3 . 22 L , 30 2 6. . 30 2 . 83 kJ/mol 30 50 7.7 . 13.5 (2 /7.7) 50 , 6. . , .

9、50 . , . X pV( , kPaL) Y 30 ( ) 1 30 KS M ISO 16038:2008 8 X , kPa Y 30 ( ) 2 30 X Y 30 ( ) 3 30 KS M ISO 16038:2008 9 8.5 , , , , . KS M ISO 4074 11. , . 8.6 KS M ISO 4074 7. . . KS M ISO 4074 , . , . , , , . . KS M ISO 4074 B . 8.7 . , . -9(nonoxynol-9) . . 9 . KS M ISO 4074 , . , 3 KS M ISO 4074

10、KS Q ISO 2859 1 . . . KS M ISO 16038:2008 10 1 ISO/TR 8550, Guide for the selection of an acceptance sampling system, scheme or plan for inspection of discrete items in lots 2 ISO/TR 13425, Guidelines for the selection of statistical methods in standardization and specification 3 KS Q ISO 2859 0, 0： KS A ISO 2859 4 KS P ISO TR 16142, 5 WHO： Compendium on male latex condom 6 KS Q ISO 9001, 7 KS P ISO 10993 1, 1： 8 KS P ISO 13485, 9 ISO 14971： 2000, Medical devices Application of risk management to