ONORM EN ISO 21536:2024

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)

This document specifies requirements for implants for knee replacement. With regard to safety, this document specifies requirements for intended function, design features, materials, design verification, manufacturing, sterilization, packaging, provision of information by the manufacturer and testing procedures. This document applies to both total and partial knee replacement implants. It applies to these prostheses both with and without replacement of the patellafemoral joint. It applies to components made of metallic and non-metallic materials. This document applies to a variety of knee replacement implants. However, some specific types of knee replacement implants may have certain considerations that are not specifically covered in this document. Further details are given in 7.2.1.2. The requirements set out in this document are not intended to require redesign or retesting of implants that have been lawfully placed on the market and have a history of sufficient and safe clinical use. Compliance of such implants with this document can be demonstrated by demonstrating sufficient and safe clinical use of the implant.