DS/EN ISO 21536/A1:2014

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 41.82

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: 16

Published: 2014-04-28

Date of approval: 2014-03-21

International relationships : EN ISO 21536:2009/A1:2014 IDT ISO 21536:2007/Amd 1:2014 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M262528


Committees

Committee

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

Danish committee

DS/S-160