KS M ISO 7439-2008 Copper-bearing intra-uterine contraceptive devices－Requirement tests《含铜的宫内节育避孕器具 试验和要求》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS M ISO 7439 KS M ISO 7439:2008 2008 12 29 http:/www.kats.go.krKS M ISO 7439:2008 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2008 12 29 2008-0980 ： ： ( 025097301) (http:/www.kats.go.kr). 10 5 , . 0980 KS M ISO 7439:2008 Copper-bearing intra-uterine

2、 contraceptive devices Requirement, tests 2002 2 ISO 7439, Copper-bearing intra-uterine contraceptive devicesRequirement, tests , . 1 ( Copper-IUD .) . . . 2 . . ( ) . EN 540, Clinical investigation of medical devices for human subjects EN 980, Graphical symbols for use in the labelling of medical d

3、evices EN 1441, Medical devices Risk analysis EN ISO 10993 1, Biological evaluation of medical devices Part 1： Evaluation and testing(ISO 10993 1： 1997) EN ISO 14630, Non-active surgical implants General requirement(ISO 14630： 1997) (European Pharmacopoeia) 3 . KS M ISO 7439:2008 2 3.1 (intra-uterin

4、e contraceptive device IUD (uterine cavity： ) Copper-IUD 3.2 (insertion instrument) IUD 3.3 (thread) IUD IUD IUD (cervical canal) (vagina) . 3.4 (visco-elastic property) IUD 3.5 (active surface area) IUD 4 4.1 EN ISO 14630： 1997 4. . 4.2 5. . IUD 3 ( ) . (life-table) , 1 100 2 (expulsion rate) , 1 1

5、00 10 5 5.1 EN ISO 14630： 1997 5. . IUD . 5.2 , IUD KS M ISO 7439:2008 3 . IUD . IUD . 5.3 5.3.1 IUD IUD 36 mm , 32 mm . 7.2.1 , 5 % . 5.3.2 200 mm2 , 380 mm2 . , 0.25 mm . 5 % , 10 % . 5.3.3 7.2.2 , 100 mm . 5.3.4 5 mm . 5 % . 5.4 7.3 , IUD 12 N . 5.5 5.5.1 IUD . 5.5.2 (in situ) , IUD 5.4 . 5.6 7.4

6、 , IUD 5 mm . KS M ISO 7439:2008 4 5.7 IUD X-ray . , 7.5 , 15 %(w/w) 25 %(w/w) . 6 EN ISO 14630： 1997 6. . (radio-opacity) , . , . 99.9 % . 7 7.1 EN ISO 14630： 1997 7.1 . 7.2 7.2.1 IUD , , (contour analyzer) . 7.2.2 , . 7.2.3 . 7.3 7.3.1 IUD IUD . . 7.3.2 , . a) ： 0 N 100 N b) ： 3.3 mm/s0.3 mm/s 200

7、 mm/min20 mm/min c) ; . 7.3.3 KS M ISO 7439:2008 5 IUD . IUD 23 2 50 %5 % 24 . IUD . , IUD IUD 5 cm . IUD . . 7.3.4 . a) b) IUD c) IUD (N) d) e) 7.4 (memory) 7.4.1 IUD . 7.4.2 IUD 23 2 50 %5 % 24 . IUD , . a) IUD IUD IUD . IUD ( ) . 5 , 1 0 . b) IUD IUD 5 10 mm0.1 mm , 1 0 . IUD . 7.4.3 . a) b) IUD

8、c) IUD d) 7.5 KS M ISO 7439:2008 6 a) . b) , ( ) ( ) A B . 7.6 EN 1441 . IUD EN ISO 10993 1 , . 7.7 IUD . EN 540 . IUD (prospective) . IUD . IUD 10 000 . 400 1 , 200 3 (in situ time) . (in situ time) 3 . . . / . KS M ISO 7439:2008 7 IUD ： , IUD , IUD , . . , IUD . ： , , , 8 EN ISO 14630： 1997, 8. .

9、9 IUD . EN ISO 14630： 1997, 9. . 10 EN ISO 14630： 1997, 10. . 11 11.1 EN ISO 14630： 1997, 11.1 11.2 . 11.2 11.3 EN 980 . 11.2 1 1 . “ ” (batch) KS M ISO 7439:2008 8 “ (For single use only)” EN 980 11.3 2 2 . “ ” 11.4 . , IUD IUD “ ” , , , . IUD ( ) , / . IUD ; IUD IUD ( ) ; IUD IUD IUD , IUD , EU Di

10、rective CE / KS M ISO 7439:2008 9 11.5 . IUD , IUD IUD ( ) KS M ISO 7439:2008 10 ZZ () , . ISO IEC . EN 540 ISO 14155, Clinical investigation of medical devices EN 980 ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied EN 1441 ISO 14971

11、 1：1), Medical devices Risk management Part 1： Application of risk analysis 1) (ISO 14971 1： 1998 )KS M ISO 7439:2008 11 EN 12011, Instrumentation to be used in association with non-active surgical implants General requirements 135513 7017 (02)60094114 (02)600948878 http:/ KS M ISO 7439:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Copper-bearing intra-uterine contraceptive devices Requirement, tests ICS 11.200 Korean Agency for Technology and Standards http:/www.kats.go.kr