ISO/NP 20014

Implants for surgery — Test method to evaluate delamination resistance of ultra-high molecular weight polyethylene materials used for orthopaedic implants ISO/NP 20014

Scope

This document specifies two separate test methods that use loading conditions more aggressive than that expected in vivo. The purpose is to compare delamination resistance of ultra-high molecular weight polyethylene (UHMWPE) materials intended to be used for a component that is expected to be loaded at low-conformity contact with a hard material.
These test methods are intended to be used for the purpose of screening during material development by comparing with a predicate material with a successful clinical history.
These test methods are not intended to test materials under loading conditions that simulate clinical conditions, nor does it guarantee the clinical relevance of the test results, nor are these test methods intended to be used on devices.
It is not the intent of this standard to require both test methods, and either can be chosen. The test method chosen will be determined by the equipment available to the user.