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 retesting 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.
Cross References:ISO 7207-1
ISO 7207-2
ISO 14243-1
ISO 14243-2
ISO 14243-3
ISO 14630
ISO 14879-1
ISO 21534:2007
93/42/EEC
Incorporates the following:Amendment, April 2014. Amends and replaces BS EN ISO 21536:2009
| File Size : | 1
file
, 1.1 MB |
| ISBN(s) : | 9780539038019 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 38 |
| Published : | 07/31/2024 |
