DS/EN ISO 21534:2009

Non-active surgical implants - Joint replacement implants - Particular requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.08
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
It specifies requirements for intended performance, design attributes, materials, design evaluation,
manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.


Number of pages: 32

Published: 2009-06-26

Date of approval: 2009-06-11

International relationships : EN ISO 21534:2009 IDT ISO 21534:2007 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M235344


Committees

Committee

  • CEN/TC 285/WG 4
  • ISO/TC 150/SC 4

Danish committee

DS/S-160