NF ISO 5834-3

NF ISO 5834-3

July 2019
Standard Current

Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3 : accelerated ageing methods

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2019

Number of pages

8 p.

Reference

NF ISO 5834-3

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-060-3

Print number

1

International kinship

ISO 5834-3:2019
Sumary
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3 : accelerated ageing methods

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

Replaced standards (1)
NF ISO 5834-3
April 2006
Standard Cancelled
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3 : accelerated ageing methods

Le présent document constitue la partie 3 de la norme ISO 5834, présentée sous le titre général "Implants chirurgicaux - Polyéthylène à très haute masse moléculaire". Le présent document décrit une méthode de laboratoire pour le vieillissement accéléré des éprouvettes et composants à base de polyéthylène à très haute masse moléculaire destinés aux prothèses totales d'articulations. Le polyéthylène à très haute masse moléculaire est soumis au vieillissement à température élevée et à pression d'oxygène élevée afin d'accélérer l'oxydation du matériau et, par ce moyen, permettre l'évaluation de sa stabilité mécanique et chimique potentielle à long terme.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Classification, désignation et codage
  • 5 Matériau
  • 6 Appareillage et éprouvettes
  • 7 Validation de l'appareillage
  • 8 Conditionnement
  • 9 Portée et utilisation
  • 10 Mode opératoire de vieillissement accéléré
  • 11 Rapport
  • Bibliographie
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