YY 0502-2016 Translated English of Chinese Standard. YY0502-2016: Joint Replacement Implants - Knee Joint Prostheseshttps://www.chinesestandard.net, 23 apr. 2018 - 19 pagini This Standard specifies the requirements for terms and definitions, classification and dimension marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, package, and information provided by the manufacturer of the knee joint prostheses. This Standard is applicable to partial or total knee joint prostheses manufactured by the materials and processes specified in this Standard. |
Cuprins
Foreword | 7 |
Coatings | 8 |
Design Evaluation | 10 |
Manufacture | 12 |
Package | 13 |
Appendix A Normative Approved Material Standard List on Manufacturing the Knee Joint Prostheses | 14 |
Composite | 15 |
Appendix B Normative Approved and NonApproved Material List on Manufacturing Articular Surface of Knee Joint Prostheses | 16 |
Termeni și expresii frecvente
8.4.1 The articular Appendix based on high-purity bone cement casting alloy ISO Ceramic Materials Based chromium cobalt-base alloy ISO contents are applicable corrected vision corresponding standard dimension and tolerance Dimension Marking Epoxyethane sterilization residue examining with normal extrusion molding finite element analysis following contents full knee joint given in ASTM given in YY/T High-Purity Alumina ISO Implants for Surgery knee joint components knee joint prostheses manufactured by mold manufacturer shall specify manufacturing the knee matrix shall reach mechanical properties meet the requirements meniscal components metal combinations metal or alloy Metallic Materials molybdenum normal or corrected Plasma sprayed products supplied prostheses shall conform provisions of corresponding requirements of YY/T Resin Cements shear strength Stainless steel ISO sterilization process surface of knee surface roughness Ra surface When visually test method given tibial components tibial tray titanium alloy titanium-base alloy ISO UHMWPE ISO Unalloyed titanium ISO visually examining Wrought Cobalt Wrought Titanium 6-Aluminum Zirconia