1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14630 KS P ISO 14630:2009 2009 1 6 http:/www.kats.go.krKS P ISO 14630:2009 : ( ) ( ) () ( ) : () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2003 12 19 ：2009 1 6 2009-0003 ： ： ( 025097266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 14630:2009 i ii .1
2、1 1 2 1 3 .2 4 .3 5 .3 6 4 7 .5 7.1 .5 7.2 5 7.3 5 7.4 .6 8 6 9 6 9.1 .6 9.2 6 9.3 .7 9.4 7 10 7 10.1 7 10.2 .7 11 .7 11.1 7 11.2 .8 11.3 9 11.4 10 11.5 .10 11.6 11 A( ) KS P ISO TR 14283 .12 13 KS P ISO 14630:2009 ii . KS P ISO 14630： 2003 . . , , . , , . KS P ISO 14630:2009 Non-active surgical imp
3、lants General requirements 2008 3 ISO 14630, Non-active surgical implants General requirements . 1 ( .) . , , (transendodontic) , (transradicular) (intra-ocular) . , , , , , , , . 2 3 . . , KS P ISO 13485 . 2 . . ( ) . KS A ISO 31( ), KS P ISO 10993 1, 1： KS P ISO 11137 1, , 1： , KS P ISO 11137 2, ,
4、 2： KS P ISO 11607 1, 1： , KS P ISO 14155 1, 1： KS P ISO 14155 2, 2： KS P ISO 17665 1, , 1： , KS X ISO 8601, ISO 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals KS P ISO 14630:2009 2 ISO 11135 1, Sterilization of health care products Ethylene oxide Pa
5、rt 1 ： Requirements for development, validation and routine control of a sterilization process for medical devices ISO 13408 1, Aseptic processing of health care products Part 1： General requirements ISO 14160, Sterilization of single use medical devices incorporating materials of animal originValid
6、ation and routine control of sterilization by liquid chemical sterilants ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Med
7、ical devices Application of risk management to medical devices ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 22442 1, Medical devices utilizing animal tissues and their derivatives Part 1： Applicati
8、on of risk management ISO 22442 2, Medical devices utilizing animal tissues and their derivatives Part 2： Controls on sourcing, collection and handling ISO 22442 3, Medical devices utilizing animal tissues and their derivatives Part 3： Validation of the elimination and/or inactivation of viruses and
9、 transmissible spongiform encephalopathy (TSE) agents 3 . 3.1 (coating) 3.2 (implantable state) 3.3 (leakage) . . 3.4 (magnetic resonance environment) MR (MR environment) (magnetic resonance imaging scanner) 3 , 0.50 mT (5 G) ASTM F2503 051), definition 3.1.7 0.50 mT Faraday shield , . , 0.50 mT Far
10、aday shield , . 1) ASTM , ASTM F2503 05 ASTM F2119 01 , ASTM International http:/www.astm.org/ .KS P ISO 14630:2009 3 3.5 (magnetic resonance imaging) MRI (static magnetic field) (time varying magnetic field) ASTM F2119 011), definition 2.1.4 3.6 (non-active surgical implant) 3.7 (safety) KS A ISO/I
11、EC Guide 51： 1999, definition 3.1 3.8 (surgical implant) , 30 4 . a) b) c) d) , . 5 . a) (6. ) b) (ageing) , , (6. 7. ) c) (6. 7. ) d) , (6. 7. ) e) (6. 7. ) f) KS P ISO 14630:2009 4 ( , ) (6. ) g) ( ) (6., 7., 8. 9. ) h) (6. 7. ) i) (7. ) j) , (7. ) k) (7. ) l) (6. 7. ) m) (7. ) n) , (6. 7. ) (MRI)
12、 . ASTM F2052, ASTM F2119, ASTM F2182 ASTM F2213 . o) , (7. ) p) q) (8., 9. 10. ) r) (10. ) . , . 6 , , ( , , , ) . , , , , , , . . . 1 , (： European Directive 2001/83/EC). , , . . . a) KS P ISO 10993 1 b) 2 2 . KS P ISO 14630:2009 5 , ISO 22442 1, ISO 22442 2, ISO 22442 3 . 3 “ ” “ ” ISO 22442 1 .
13、7 7.1 (4. ) . . ISO 14971 , (post-market surveillance) . 7.2 . a) , , b) c) , . . , . 7.3 . a) , , , b) , c) a) b) KS P ISO 14155 1 KS P ISO 14155 2 . 1 . 2 KS P ISO 14155 2 (CIP) . . KS P ISO 14630:2009 6 7.4 . , . , ( ), , ( 3 ). 8 . . 9 9.1 , , . 9.2 . “ (STERILE)” , 110 6 . 2 3 . , . KS P ISO 11
14、135 1 . KS P ISO 11137 1 KS P ISO 11137 2 . KS P ISO 17665 1 . ISO 14160 . ISO 14937 . KS P ISO 14630:2009 7 ISO 13408 1 . 9.3 9.3.1 , . (11. ). 9.3.2 , ISO 17664 . . 9.4 KS P ISO 10993 1 . ISO 10993 7 . 10 10.1 , ( , ) , . 1 EN 60068 2 27, EN 60068 2 32 EN 60068 2 47 (A.2 ). 2 . . 10.2 “ (STERILE)”
15、 , . KS P ISO 11607 1 . 11 11.1 215 lx , , . 1 / , . KS P ISO 14630:2009 8 , , . . , , . , (： KS S ISO 7000) . , , . . KS A ISO 31 , SI . . 2 SI KS A ISO 1000 , / , , . , . , . , . KS X ISO 8601 , YYYY MM DD, YYYY MM, YYYY . 11.2 . a) , . b) c) (： ), , (batch number) 1 KS S ISO 7000 2492 KS S ISO 70
16、00 2498 “LOT”, “SN”, d) , e) , 2 KS S ISO 7000 2499 “ (STERILE)” , KS S ISO 7000 2500, KS S ISO 7000 2501, KS S ISO 7000 2502 KS S ISO 7000 2503 “ ” KS P ISO 14630:2009 9 f) , , 3 KS S ISO 7000 2609 “ ” g) , “ ” 4 KS S ISO 7000 2607 “ ” h) 5 KS S ISO 7000 1051 “ ” i) / j) k) 11.3 , . a) , b) c) (： ), d) , e) 4. f) ( ) , g) , h) i) 1 KS S ISO 7000 2499 “ (STERILE)” , KS S ISO 7000 2500, KS S ISO 7000 2501, ISO 7000 2502 KS S ISO 7000 2503 “ ” j) , , k) 2 , , l) , m) 3 KS S ISO 7000 1051 “ ” n) / KS P ISO 14630:2009 10 o) (： )
