1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 21536 KS P ISO 21536:2009 2009 12 25 http:/www.kats.go.krKS P ISO 21536:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 21536:2009 . . ii 1 1 2 1
2、 3 .1 4 (Intended performance).2 5 (Design attributes) .2 5.1 (General) 2 5.2 (Thickness of UHMWPE in tibial components and meniscal components)25.3 (Finish of non-articulating regions of metallic knee joint components) .36 (Materials) .3 7 (Design evaluation) .3 7.1 (General) 3 7.2 (Preclinical eva
3、luation)3 8 (Manufacture) .4 9 (Sterilization) .4 10 (Packaging) 4 11 (Information to be supplied by the manufacturer) 4 11.1 (General) 4 11.2 (Information supplied on the label) .4 11.3 (Constructional compatibility of components) .4 11.4 (Information for the patient) .4 11.5 (Marking) 4 A( ) .5 i
4、KS P ISO 21536:2009 2007 2 ISO 21536, Non active surgical implantsJoint replacement implantsSpecific requirements for knee joint replacement implants . . 1 . 1 ： 2 ： 3 ： 3 . 1 . 2 3 . 2 , . . ii KS P ISO 21536:2009 Non-active surgical implantsJoint replacement implants Specific requirements for knee
5、joint replacement implants 1 . , , , , , , . 2 . . ( ) . KS P ISO 72071, 1 ： , KS P ISO 142431, 1： KS P ISO 14243 2, 2 ： KS P ISO 14243 3, 3 ： KS P ISO 14630, KS P ISO 14879 1, 1 ： KS P ISO 21534, 3 KS P ISO 21534 KS P ISO 72071 . 3.1 (femoral component) . 3.2 (tibial component) KS P ISO 21536:2009
6、 . 3.3 (tibial tray) 3.4 (patellar component) 3.5 (patellar tray) 3.6 (unicompartmental knee joint prosthesis) KS P ISO 7207 1 3.1.2 . 3.7 (meniscal component) 4 (Intended performance) KS P ISO 21534 4. . KS P ISO 21534 4. a) . A . . 5 (Design attributes) 5.1 (General) KS P ISO 21534 5. . 5.2 (Thick
7、ness of UHMWPE in tibial components and meniscal components) UHMWPE(ultra high molecular weight polyethylene) . . a) 6 mm b) 9 mm 2 KS P ISO 21536:2009 5.3 (Finish of non-articulating regions ofmetallic knee joint components) . Ra 1.5 m . 6 (Materials) KS P ISO 21534 6. . . 7 (Design evaluation) 7.1
8、 (General) KS P ISO 21534 7. . KS P ISO 21534 7.2 . a) ( ) b) . 7.2 (Preclinical evaluation) 7.2.1 (Endurance of tibial trays of knee joint components Cemented and non-cemented) KS P ISO 14879 1 . 5 10 106 900 N (KS P ISO 14879 1 ). . KS P ISO 14879 1 . 900 N . . 7.2.2 (Wear testing of total knee jo
9、int replacements) KS P ISO 14243 1, KS P ISO 14243 2, KS P ISO 14243 3 . 3 KS P ISO 21536:2009 8 (Manufacture) KS P ISO 21534 8. . , (cobalt chromium) . . 1 200 4 . 9 (Sterilization) KS P ISO 14630 9. . 10 (Packaging) KS P ISO 14630 10. . 11 (Information to be supplied by the manufacturer) 11.1 (Gen
10、eral) KS P ISO 14630 11. 11.2 11.5 . 11.2 (Information supplied on the label) . a) b) ( ) (KS P ISO 72071 ), , , c) (KS P ISO 7207 1 ) , , d) ( ) 11.3 (Constructional compatibility of components) . , , , . . 11.4 (Information for the patient) . “ .” 11.5 (Marking) KS P ISO 21534 11. . 4 KS P ISO 215
11、36:2009 A () A.1 . . A.2 / 1 . 5 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 21536:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Non-active surgical implants Joint replacement implants Specific requirements for knee-joint replacement implants ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr
