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prSSH EN ISO 21536:2024

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

General information

40.20     Feb 10, 2025

40.60    May 6, 2025

DPS

DPS/KT 205

European Norm

11.040.40  

Scope

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.

Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 21536:2009

PUBLISHED
SSH EN ISO 21536:2009/A1:2014

NOW

IN_DEVELOPMENT
prSSH EN ISO 21536:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN ISO 21536:2024 IDENTICAL

Adopted from ISO 21536:2023 IDENTICAL

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