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Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices

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Description

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices1. Scope 1. 1 This guide covers materials and design recommendations and general test methods for the chemical, mechanical, and preclinical assessment of implantable devices with hard on hard articulations intended to replace a hip joint. The provided guidance is intended to encompass both Total Hip Replacement (THR) devices with stems that extend or fix within the intramedullary canal as well as Hip Resurfacing Arthroplasty (HRA) wherein only the hip

Several test levels are defined which relate to different environments and installation conditions

BS EN 61158-6-3 is concerned

are not included in the results

1 has been replaced with a new type

The polymeric material used for stress design layers and all inner layers must be polyethylene (PE) and/or crosslinked polyethylene (PE-X)

Why should you use BS 1868 - Specification for steel check valves

Who is ISO 4064-4 - Non-metrological requirements of water meters for

This International Standard specifies criteria for authenticity of soluble (instant) coffee

several techniques can be used

Demonstrate conformity to ISO 16000‑40

test procedures and the evaluation criteria described in BS EN 61467 are intended to provide

quality algorithms

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