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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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

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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