Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices Ingestion-build-95349 Harmonized standard covering the essential

Harmonized standard covering the essential requirements of article 3

This PAS is for use by:

It also establishes basic rules for the design and application of the test equipment and its interface with the systems important to safety

This first amendment to Part 1 of BS EN 62563 supersedes the 2010 version of the standard which will be withdrawn on 28 April 2019

and specification of the metadata elements required to describe a learning resource

Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices Ingestion-build-95349 Harmonized standard covering the essential1. 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