YY 0502-2005 Translated English of Chinese Standard. YY0502-2005: Knee joint prosthesesThis Standard specifies the definitions, classification, intended performance, requirements, test methods, inspection rules, marking, instructions for use, packaging, transportation, and storage of knee joint prostheses. This Standard is applicable to non-active surgical implants that replace partial or full knee joint of human body. |
Common terms and phrases
and/or articulating surfaces based alloys ISO bearing surface Tibial Bicondylar bone cement Ceramic Materials Based cobalt based alloys Cobalt-chromium-molybdenum casting alloy cobalt-chromium-nickel-molybdenum-iron alloy ISO cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Components for Partial condyle dimensions Femoral and Tibial femoral components femur Forgeable and cold-formed Implants for Surgery Implants ISO Instructions intended performance intracondylar projection Femoral intramedullary stem Joint Replacement Implants knee joint prostheses knee joint replacement lot-by-lot inspection Manufacture Practice manufacturing knee joint Materials Found Acceptable meet the requirements metallic and ceramic Metallic Materials molecular weight polyethylene Non-active Surgical Implants overall width Oxide Sterilization Residuals Partial and Total Patella bearing surface Patella component periodic inspection plateau Tibial prostheses shall meet Resin Cements specific test Stainless steel ISO surfaces of knee Tibial bearing surface Tibial Components Tibial plateau tibial stem titanium based alloys total joint replacements total knee joint UHMWPE ISO ultrahigh molecular weight Unalloyed titanium ISO Wrought Titanium 6-Aluminium