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SS-EN ISO 21535:2009/A1:2016
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016) (Swedish Standard)
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
Swedish Standards Institute [sis]