ISO 21534:2002

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

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, hereinafter referred to as implants.

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 compliance with this International Standard are contained in or referenced in level 3 standards.


General information

  • Status :  Withdrawn
    Publication date : 2002-11
  • Edition : 1
  • :
    ISO/TC 150/SC 4
    Bone and joint replacements
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

Subscribe