YY 0118-2016: Translated English of Chinese Standard. YY0118-2016: Joint Replacement Implants - Hip Joint Prostheses
https://www.chinesestandard.net, 2016 M08 10 - 23 pages
This Standard specifies the terms and definitions, classification and size marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, packing, and manufacturer information requirements for the total-hip and partial-hip joint prostheses.
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Terms and Definitions
applicable based alloys ISO Calcium Phosphate ceramic femoral component Ceramic Materials Based Clause cobalt based alloys cobalt-chromium-nickel-molybdenum-iron alloy ISO cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Composite Materials conventional UHMWP diameter shall equal Dimension and tolerance Ethylene Oxide Sterilization femoral component matched Forgeable and cold-formed GB/T hip joint prostheses hip joint replacement Hydroxyapatite Implants for Surgery Joint Replacement Implants Manufacturer shall specify mechanical properties metallic and ceramic Metallic Materials method specified Molecular Weight Polyethylene Molybdenum nominal value Partial and Total performance of stemmed Plasma spraying plastic acetabular component prostheses shall conform provisions of corresponding requirements of YY/T roundness radial deviation specified in ASTM specified in YY/T spherical articulating surface spherical diameter spherical roundness radial Stainless steel ISO Standard Test Method stemmed femoral component surface of metallic surface roughness Ra Surfaces of Hip titanium based alloys total hip joint UHMWPE ISO UHMWPE materials Ultra-high Molecular Weight Unalloyed titanium ISO Wrought Titanium 6-aluminium Zirconia