KS P ISO 21534-2009 Non－active surgical implants－Joint replacement implants－Particular requirements《非活性外科植入物 关节替代用植入物 特殊要求》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 21534 KS P ISO 21534:2009 2009 12 25 http:/www.kats.go.krKS P ISO 21534:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 12 22 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 21534:2009 . iii 1 1 2 1

2、3 .1 4 (Intended performance).2 5 (Design attributes) .2 5.1 (General).2 5.2 (Surface finish of metallic or ceramic implants articulating on UHMWPE).35.3 (Surface finish of metallic or ceramic partial implants) .35.4 (Surfaces of convex, spherically conforming metallic or ceramic articulating on UHM

3、WPE) .35.5 (Surfaces of spherically conforming metallic or ceramic partial implants).35.6 UHMWPE (Surfaces of concave, spherically conforming UHMWPE components) .36 (Materials) .3 6.1 (General).3 6.2 (Dissimilar metals or alloys) .4 7 (Design evaluation) .4 7.1 (General).4 7.2 (Preclinical evaluatio

4、n)4 7.3 (Clinical evaluation).5 7.4 (Post market surveillance).5 8 (Manufacture and inspection) 5 8.1 (General).5 8.2 (Metal surfaces) 5 8.3 (Plastic surfaces).5 8.4 (Ceramic surfaces)5 9 (Sterilization) .5 9.1 (General).5 9.2 (Expiry) .6 10 (Packaging) 6 i KS P ISO 21534:2009 11 (Information suppli

5、ed by the manufacturer) 6 11.1 (General).6 11.2 (Labelling of implants for use on one side of the body only).611.3 (Instructions for orientation of implants) 6 11.4 (Markings for orientation of the implants) 6 11.5 (Placing of markings on implants).6 11.6 (Restrictions on use).6 11.7 (Re-sterilizati

6、on of zirconia ceramics)6 11.8 (Labelling of implants for use with or without bone cement) .7 A( ) 8 B( ) .9 B.1 (Suitable material combinations) 9 B.2 (Unsuitable combinations of materialsfor articulating surfaces) 9 C( ) .11C.1 (Suitable combinations of dissimilar metals for non articulating conta

7、cting surfaces)11C.2 (Non acceptable metalliccombinations for non articulating contacting surfaces)11 12 ii KS P ISO 21534:2009 2007 2 ISO 21534, Non active surgical implantsJoint replacement implantsParticular requirements . ISO/TC 150 “ ” SC 4 “ ” . 2 1 . . 1 . 1 ： 2 ： 3 ： 2 . 1 . 2 3 . 1 KS P ISO

8、 14630 . 3 . . iii KS P ISO 21534:2009 Non active surgical implantsJoint replacement implants Particular requirements 1 , . . , , , , , , . 3 . 2 . . ( ) . KS B ISO 4287, (GPS) , KS P ISO 7206 4, 4 ： KS P ISO 7206 8, 8 ： KS P ISO 14155 1, 1 ： KS P ISO 142421, 1： KS P ISO 14242 2, 2 ： KS P ISO 14243

9、2, 2 ： KS P ISO 14630, KS P ISO 14879 1, 1 ： 3 KS P ISO 14630 . KS P ISO 21534:2009 3.1 (artificial ligament) 3.2 (joint replacement implant) 3.3 (mean centre) 3.4 (radial separation value) ( m) . 4 (Intended performance) KS P ISO 14630 4. , . a) b) ( ) c) / d) e) f) 1 . 2 . , , , , . 5 (Design attr

10、ibutes) 5.1 (General) KS P ISO 14630 5. , . a) b) c) 2 KS P ISO 21534:2009 d) , e) 1 (KS P ISO 142422, KS P ISO 14243 1, KS P ISO 14243 2, KS P ISO 14243 3). 2 . 5.2 (Surface finish of metallic or ceramic implants articulating on UHMWPE) Ra 0.1 m (7.2.2 ). 5.3 (Surface finish of metallic or ceramic

11、partial implants) Ra 0.5 m ( 7.2.2 ). 5.4 (Surfaces of convex, spherically conforming metallic or ceramic implants articulating onUHMWPE) , Ra 0.05 m 10 m (7.2.2 7.2.3 ). 5.5 (Surfaces of spherically conformingmetallic or ceramic partial implants) Ra 0.5 m 100 m (7.2.2 7.2.3 ). 5.6 UHMWPE (Surfaces

12、of concave, spherically conformingUHMWPE components) Ra 2 m 200 m ( 7.2.2 7.2.3 ). 6 (Materials) 6.1 (General) KS P ISO 14630 6. 6.2 . 1 A 3 KS P ISO 21534:2009 . 2 B . 3 KS P ISO 14630 6.1 . 500 5 . 6.2 (Dissimilar metals or alloys) (metallurgical) (galvanic effect) . C , . 7 (Design evaluation) 7.

13、1 (General) . 7.2 7.4 KS P ISO 14630 7. . . 7.2 (Preclinical evaluation) 7.2.1 (General) . a) b) KS P ISO 14630 c) (KS P ISO 7206 4, KS P ISO 7206 8, KS P ISO 14879 1) d) (KS P ISO 14242 1, KS P ISO 14242 2, KS P ISO 14243 1) e) ( ) X , CAT (6.1 3 ). f) , 7.2.2 (Surface roughness measurement) KS B I

14、SO 4287 . 7.2.3 (Sphericity measurement) . 4 KS P ISO 21534:2009 7.3 (Clinical evaluation) KS P ISO 14155 1 . 7.4 (Post market surveillance) . . . 8 (Manufacture and inspection) 8.1 (General) 8.2 8.4 KS P ISO 14630 8. . 8.2 (Metal surfaces) . , , . . , , , , , , . 8.3 (Plastic surfaces) . . , , . 8.

15、4 (Ceramic surfaces) . , , , , , . 9 (Sterilization) 9.1 (General) KS P ISO 14630 9. . 5 KS P ISO 21534:2009 4. 7.2.1 c), d) f) . , 40 kGy . . 9.2 (Expiry) . 10 (Packaging) KS P ISO 14630 10. . (9.2 ). 11 (Information supplied by the manufacturer) 11.1 (General) KS P ISO 14630 11. 11.2 11.8 . 11.2 (

16、Labelling of implants for use on one side of the body only) “LEFT” , “RIGHT” . 11.3 (Instructions for orientation of implants) / . ( 11.2 11.4 ). 11.4 (Markings for orientation of the implants) / “ANT” / “POST” ( 11.3 ). 11.5 (Placing of markings on implants) 7.2.1 c), d), f) . 11.6 (Restrictions on

17、 use) . 11.7 (Re-sterilization of zirconia ceramics) “ ” . 6 KS P ISO 21534:2009 11.8 (Labelling of implants for use with or without bone cement) 1 . 1 7 KS P ISO 21534:2009 A () . . 7. . KS P ISO 58321, 1 ： KS P ISO 58322, 2 ： KS P ISO 58323, 3 ： 6 4 KS P ISO 58324, 4 ： KS P ISO 58325, 5 ： KS P ISO

18、 58326, 6 ： KS P ISO 58327, 7 ： KS P ISO 5832 8, 8 ： KS P ISO 58329, 9 ： KS P ISO 583211, 11： 6 7 KS P ISO 583212, 12： KS P ISO 5833, KS P ISO 58341, 1： KS P ISO 58342, 2： KS P ISO 6474, KS P ISO 13356, (Y TZP) KS P ISO 13779 1, 1： KS P ISO 13779 2, 2： KS P ISO 13779 4, 4： 8 KS P ISO 21534:2009 B ()

19、 B.1 (Suitable material combinations) A , , . a) wrought stainless steel(KS P ISO 58321)/UHMWPE(KS P ISO 5834 1, KS P ISO 58342) b) wrought high nitrogen stainless steel(KS P ISO 5832 9)/UHMWPE(KS P ISO 5834 1, KS PISO 58342) c) cobalt chromium molybdenum casting alloy(KS P ISO 5832 4)/UHMWPE(KS P I

20、SO 5834 1, KS P ISO 5834 2) d) wrought cobalt chromium tungsten nickel alloy(KS P ISO 5832 5)/UHMWPE(KS P ISO 5834 1, KS P ISO 5834 2) e) forgeable and cold formed cobalt chromium nickel molybdenum iron alloy(KS P ISO 5832 7)/ UHMWPE(KS P ISO 58341, KS P ISO 5834 2) f) wrought cobalt nickel chromium

21、 molybdenum tungsten iron alloy(KS P ISO 5832 8)/UHMWPE(KS P ISO 5834 1, KS P ISO 58342) g) wrought titanium 6 aluminium 4 vanadium alloy1)(KS P ISO 5832 3)/UHMWPE(KS P ISO 5834 1,KS P ISO 5834 2) h) wrought titanium 6 aluminium 7 niobium alloy1)(KS P ISO 5832 11)/UHMWPE(KS P ISO 5834 1,KS P ISO 583

22、4 2) i) ceramic materials based on alumina1)(KS P ISO 6474)/UHMWPE(KS P ISO 58341, KS P ISO58342) j) ceramic materials based on zirconia(KS P ISO 13356)/UHMWPE(KS P ISO 58341, KS P ISO58342) k) ceramic materials based on alumina(KS P ISO 6474)/ceramic materials based on alumina(KS P ISO 6474) l) forgeable and cold formed cobalt chromium nickel molybdenum iron alloy(KS P ISO 58327)/ forgeable and cold formed cobalt c