Rationale

The proposed revisions will: - change the scope to no longer call out specific preclinical functional component tests for UHMWPE joint implant devices but instead point to device specific standards, examples of such tests will still be included (see 7.4) - introduce new terms, - harmonize some of the information in Table 3 with ASTM F648, and - clarify the material characterization process for unaged and aged materials.