BS EN ISO 21536:2009+A1:2014

This standard BS EN ISO 21536:2009+A1:2014 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

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.