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.
ISO 21535:2002 history
2023ISO 21535:2023 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
2016ISO 21535:2007/Amd 1:2016 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants; Amendment 1
2007ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
2002ISO 21535:2002 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants