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prEN ISO 21536

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021)

General information
Draft
Base Documents
ISO/DIS 21536; prEN ISO 21536
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.04.2014
Amendment
03.12.2009
Main
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.
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