This European Standard provides specific requirements for hip joint replacement implants.
With regard to safety, the standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and methods of test.
BS EN 12563:1999 history
2010BS 3HR 2:2010+A2:2012 Specification for nickel-chromium-cobalt-titanium-aluminiumheat-resistin g alloy billets, bars, forgings and parts (Nickel base, Cr19.5, Co 18.0, Ti 2.5, Al 1.5)
2010BS 3HR 2:2010+A1:2011 Specification for nickel-chromium-cobalt-titanium-aluminium heat-resisting alloy billets, bars, forgings and parts (Nickel base, Cr 19.5, Co 18.0, Ti 2.5, Al 1.5)
2009BS EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
2008BS EN ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hipjoint replacement implants (ISO 21535:2007)
1999BS EN 12563:1999 Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants