YY 0341.2-2020 Translated English of Chinese Standard (YY0341.2-2020): Non-active surgical implants -- Osteosynthesis and spinal implants -- Part 2: Particular requirements for spinal implantsThis Part of YY 0341 specifies the special requirements for non-active surgical spinal implants (hereinafter referred to as "spinal implants"). In addition to the requirements that are specified in YY/T 0640, it also specifies the definition, requirements, test methods, manufacturing, sterilization, packaging and information provided by the manufacturer of spinal implants. This Part of YY 0341 applies to non-active surgical spinal implants other than artificial intervertebral disc implants. |
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4.2 Hardness 4.3 Static and/or 4.4 Corrosion resistance 4.5 Surface quality 4.5.1 Surface defects 4.5.2 Surface roughness 4.6 Dimensions alloy YY/T and/or dynamic mechanical Anodized surface treatment calcium phosphate Coatings 5.7.1 Coatings Coatings of hydroxyapatite Coatings of surgical coatings on metallic corresponding standards dynamic load tests dynamic mechanical properties electrical measurement method ethylene oxide Implants for surgery implants shall meet lactide manufacturer shall specify material standards meet the requirements Metallic materials metallic spinal implants metallic surgical implants Non-active surgical implants non-active surgical spinal Note number of samples performed according pitting corrosion Plasma-sprayed unalloyed titanium quality 4.5.1 Surface relevant product standards specified in YY/T specify the coating spinal skeletal system stainless steel Standard Test Method Static and/or dynamic substrates or coatings Surface quality 5.5.1 surgical fixation surgical implants YY/T surgical spinal implants Test method GB/T titanium alloy titanium and titanium unalloyed titanium coatings validated methods Vickers hardness test Wrought cobalt