BS EN ISO 21535:2009+A1:2016

What is this standard about?

This international standard contains requirements applying specifically to hip joint replacement implants.

Who is this standard for? 

• Manufacturers and suppliers of non-active surgical implants
• Testers of non-active surgical implants
• Medical/healthcare organizations

Why should you use this standard? 

This is a level 3 safety standard for non-active surgical implants, specific to hip replacements. It covers the specific requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and test methods.

What’s changed since the last update?

BS EN ISO 21535 has been systematically reviewed by experts, who have taken into consideration recent technological and industry developments plus changes to medical best practice. Changes include:

• Amendments to acetabular components and bi-polar heads 
• Additions to requirements for sterilization and packaging procedures