NF ISO 5834-1

NF ISO 5834-1

July 2019
Standard Current

Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1 : powder form

This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products.

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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 5834-1

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-060-1

Print number

1

International kinship

ISO 5834-1:2019
Sumary
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1 : powder form

This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.

It is not applicable to finished products.

Replaced standards (1)
NF ISO 5834-1
June 2007
Standard Cancelled
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1 : powder form

Le présent document spécifie les exigences et les méthodes d'essai correspondantes pour les produits à mouler sous forme de poudre de polyéthylène à très haute masse moléculaire (PE-UHMW), utilisés dans la fabrication d'implants chirurgicaux. Il ne s'applique pas aux produits finis.

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Classification, désignation et codage
  • 5 Exigences de fabrication
  • 6 Propriétés d'écoulement
  • 7 Limites de contamination
  • 8 Méthodes d'essai
  • 9 Rapport d'essai
  • 10 Étiquetage
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