21/30390836 DC

This standard 21/30390836 DC BS EN ISO 21536. 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 document provides specific requirements for knee joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials.

This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, may be applicable. Further details are given in Clause 7.2.1.1.

The requirements which are specified in this document are not intended to require the re-design or re-testing of devices which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such devices compliance with this document shall be demonstrated by providing evidence of the sufficient and safe clinical use.