ISO 21534:2007 Preview
Non-active surgical implants -- Joint replacement implants -- Particular requirements
This standard was last reviewed and confirmed* in 2016.
*Therefore this version remains current
ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.