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ISO 21534:2007
M00006927
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ISO 21534:2007 Non-active surgical implants - Joint replacement implants - Particular requirements
standard by International Organization for Standardization, 10/01/2007
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Full Description
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.