YY 0502-2016: Translated English of Chinese Standard. YY0502-2016: Joint Replacement Implants - Knee Joint Prostheses
https://www.chinesestandard.net, 2018 M04 23 - 19 pages
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.
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Appendix A Normative Approved Material Standard List on Manufacturing the Knee Joint Prostheses
Appendix B Normative Approved and NonApproved Material List on Manufacturing Articular Surface of Knee Joint Prostheses
alloy powder Appendix based on high-purity bone cement Calcium Phosphate casting alloy ISO Ceramic Materials Based chromium cobalt-base alloy ISO Composite Materials contents are applicable corrected vision corresponding standard dimension and tolerance Dimension Marking examining with normal extrusion molding finite element analysis following contents full knee joint full knee replacement given in ASTM given in YY/T Implants for Surgery joint components expected knee joint components knee joint prostheses manufacturer shall specify manufacturing the knee mechanical properties meet the requirements 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 Stainless steel ISO sterilization process strength between coating surface of knee surface roughness Ra surface When visually test method given tibial components tibial tray titanium alloy titanium-base alloy ISO UHMWPE ISO UHMWPE material according Unalloyed titanium ISO visually examining Wrought Cobalt Wrought Titanium 6-Aluminum Zirconia