KS P ISO 15374-2009 Implants for surgery－Requirements for production of forgings《外科植入物 锻件制品要求》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15374 KS P ISO 15374:2009 2009 12 21 http:/www.kats.go.krKS P ISO 15374:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 15374:2009 Implants for su

2、rgery Requirements for production of forgings 1998 1 ISO 15374, Implants for surgery Requirements for production of forgings , . 1 , , . . 2 . . ( ) . KS B 0802(ISO 6892), KS P ISO 5832 1, 1： KS P ISO 5832 2, 2： KS P ISO 5832 3, 3： 6 4 KS P ISO 5832 4, 4： KS P ISO 5832 5, 5： KS P ISO 5832 6, 6： KS P

3、 ISO 5832 7, 7： KS P ISO 5832 8, 8： KS P ISO 5832 9, 9： KS P ISO 5832 11, 11： 6 7 KS P ISO 5832 12, 12： EN 10204： 1991, Metallic products Types of inspection documents ETTC 2： 19951), Microstructural standards for alpha beta titanium alloy bars 1) Deutsche Titan GmbH, Essen, Germany Timet UK Ltd., B

4、irmingham, UK KS P ISO 15374:2009 2 . 3 . 3.1 (closed-die forging) 3.2 (batch), (lot) . 3.3 (open-die forging) . 3.4 (forging) 4 (composition of forging stock) . , KS P ISO 5832 . 5 (process control) 5.1 (temperature) . , . 5.2 (shear banding) , . 5.3 (surface) 5.3.1 (general) . . , ISO . . KS P ISO

5、 15374:2009 3 5.3.2 (forgings made of unalloyed titanium or of titanium alloy) . 5.4 (hydrogen content of forgings made of unalloyed titanium or of titanium alloy) , 0.015 %( ) . 5.5 (heat treatment) . , , . 6 (mechanical testing of forgings) KS B 0802(ISO 6892) . KS P ISO 5832 . 7 (microstructure)

6、7.1 (general) , . . 7.2 (grain size) 7.2.1 (forgings made of stainless steel) KS P ISO 5832 . 7.2.2 (forgings made of unalloyed titanium) ASTM E112 , 5 . 7.2.3 (forgings made of titanium alloy) ETTC 2 , KS P ISO 5832 . 8 (traceability) (3.2 ) . KS P ISO 15374:2009 4 9 (identification and delivery) 9

7、.1 . 9.2 . a) b) c) 9.3 ( EN 10204 ) . a) b) c) d) e) f) g) h) i) ： , , , , , , , , , , , 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 15374:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Requirements for production of forgings ICS 11.040.40