DS/EN ISO 21536:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.80
Legislation:

Legislation

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

Harmonized standards:
Links

Scope

This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.


Number of pages: 24

Published: 2009-06-26

Date of approval: 2009-06-11

International relationships : EN ISO 21536:2009 IDT ISO 21536:2007 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M235346


Committees

Committee

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

Danish committee

DS/S-160