Tagasi

ISO 21536:2023

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants

Üldinfo
Kehtiv alates 05.07.2023
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
05.07.2023
Põhitekst
24.02.2014
Muudatus
26.09.2007
Põhitekst
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.
*
*
*
PDF
169,14 € koos KM-ga
Paber
169,14 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN ISO 21534:2009

Mitteaktiivsed kirurgilised implantaadid. Liigest asendavad implantaadid. Erinõuded
Uusim versioon Kehtiv alates 06.11.2009
Põhitekst

ISO 4587:2003

Adhesives -- Determination of tensile lap-shear strength of rigid-to-rigid bonded assemblies
Uusim versioon Kehtiv alates 19.03.2003
Põhitekst

ISO 17327-1:2018

Non-active surgical implants -- Implant coating -- Part 1: General requirements
Uusim versioon Kehtiv alates 16.02.2018
Põhitekst

ISO 13779-4:2018

Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength
Uusim versioon Kehtiv alates 03.12.2018