KS P ISO 8871-3-2009 Elastomeric parts for parenterals and for devices for pharmaceutical use-Part 3:Determination of released-particle count《非肠道及制药设备用弹性件 第3部分 释放粒子计数的测定》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 7207 2 2: , KS P ISO 7207 2:2012 2012 12 27 http:/www.kats.go.krKS P ISO 7207 2:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2002 6 29 :2012 12 27 2012-0767 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 7207 2:2012 i . KS P I

2、SO 7207 2: 2007 . . , , . , , . KS P ISO 7207 2:2012 ii 2011 2 ISO 7207 2, Implants for surgery Components for partial and total knee-joint prostheses Part 2: Articulating surfaces made of metal, ceramic and plastics materials . KS P ISO 7207 2:2012 2: , Implants for surgery Components for partial a

3、nd total knee joint prostheses Part 2: Articulating surfaces made of metal, ceramic and plastics materials 1 KS P ISO 7207 1 . 2 . . ( ) . ISO 4287, Geometrical Product Specifications(GPS) Surface texture: Profile method Terms, definitions and surface texture parameters ISO 4288:1996, Geometrical Pr

4、oduct Specifications(GPS) Surface texture: Profile method Rules and procedures for the assessment of surface texture 3 3.1 ISO 4288:1996, 5.3 . Ramax . 3.2 (total knee-joint prostheses) 3.2.1 (metallic or ceramic femoral components) ISO 4287 , 10 mm . 0.08 mm 0.1 m Ramax . 2 , 3 . KS P ISO 7207 2:20

5、12 2 Ra . a) (stylus tip) b) , , , , . 3.2.2 (plastics tibial and patella components) ISO 4287 , 10 mm . 0.08 mm , 0.1 m Ramax . Ra . a) (stylus tip) b) , , , , . 3.2.3 (metallic or ceramic femoral prostheses for partial knee joint replacement) ISO 4287 , 10 mm . 0.08 mm , 2 m Ramax . Ra . a) (stylu

6、s tip) b) , , , , . KS P ISO 7207 2:2012 3 1 KS P ISO 7207 1, 1: , 2:, 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 7207 2:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryComponents for partial and total knee joint prostheses Part 2:Articulating surfaces made of metal, ceramic and plastics materials ICS 11.040.40

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