YY 0118-2005 Translated English of Chinese Standard. YY0118-2005: Hip joint prostheseshttps://www.chinesestandard.net, 25. maj 2015 - 27 sider This Standard specifies the definitions, classification, requirements, test methods, inspection rules, marking, packaging, instructions for use, transportation, storage etc. of total-hip and partial-hip joint replacements. |
Indhold
Foreword | 8 |
Definitions in Chapter 3 adopts the definition part in ISO 21535 Nonactive | 11 |
Scope | 15 |
Appendix B Normative List of Materials Found Acceptable or | 21 |
Almindelige termer og sætninger
accordance with GB/T accordance with ISO and/or articulate with biological bacterium based alloys ISO biological acetabulum ceramic femoral components ceramic-on-ceramic articulating surfaces components of total corresponding standards Dimensions and tolerances Endurance properties ethylene oxide sterilization greater than 100 hip joint prostheses hip joint replacements Hydroxyapatite Implants for Surgery Instructions intended to articulate internal quality joint replacement implants joint replacements intended lot-by-lot inspection manufacturer shall specify manufacturing hip joint meet the requirements metal-on-metal and ceramic-on-ceramic metallic and ceramic Metallic Materials nominal value periodic inspection plastic acetabulum components polyethylene prostheses shall meet radial separation value region of stemmed requirements of corresponding Resin Cements roughness value Ra spherical articulating surfaces spherical diameters Stainless steel ISO stemmed femoral components structure of forgings supplied in non-sterile supplied in sterile surface roughness value surfaces of hip surfaces of metallic tested in accordance titanium alloy total hip joint UHMW UHMWPE ISO Unalloyed titanium ISO value for sphericity