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

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Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices1. Scope 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

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