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prSSH EN ISO 21535:2024

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)

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 hip-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 hip joint replacement implants. It applies to components made of metallic and non-metallic materials.
This document applies to a wide variety of hip replacement implants, but for some specific hip 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 21535:2009

PUBLISHED
SSH EN ISO 21535:2009/A1:2016

NOW

IN_DEVELOPMENT
prSSH EN ISO 21535:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN ISO 21535:2024 IDENTICAL

Adopted from ISO 21535:2023 IDENTICAL

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