【国外标准】 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders.4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model.4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review.(A) For materials terminally sterilized by gamma or e-beam irradiation.1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.