DIN Standards Committee Optics and Precision Mechanics
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
Abstract
This document specifies requirements for knee-joint replacement implants. Regarding 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, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant's sufficient and safe clinical use.
Begin
2019-01-22
WI
00285136
Planned document number
EN ISO 21536
Responsible national committee
NA 027-05-05 AA - Endoprosthesis and osteosynthesis
Responsible european committee
CEN/TC 285 - Non-active surgical implants
draft standard
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)
2023-03
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previous edition(s)
Order from DIN MediaNon-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
2009-05
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