YY 0502-2016 Translated English of Chinese Standard. YY0502-2016: Joint Replacement Implants - Knee Joint Prostheses [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]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. |
Contents
Foreword | 7 |
Design Evaluation | 10 |
Manufacture | 12 |
Package | 13 |
Appendix A Normative Approved Material Standard List on Manufacturing the Knee Joint Prostheses | 14 |
Powder Form | 15 |
Appendix B Normative Approved and NonApproved Material List on Manufacturing Articular Surface of Knee Joint Prostheses | 16 |
Common terms and phrases
Appendix articular surface roughness based on high-purity bone cement casting alloy ISO Ceramic Materials Based chromium cobalt-base alloy ISO Cobalt-Chromium-nickel-Molybdenum-Iron 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 manufacturer shall specify manufacturing the knee matrix shall reach mechanical properties meet the requirements metal combinations metal or alloy Metallic Materials molybdenum normal or corrected Plasma sprayed prostheses shall conform provisions of corresponding requirements of YY/T Resin Cements Stainless steel ISO sterilization process stipulated in YY/T supplied in non-sterilized 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