DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

prSSH EN ISO 21536:2024

Implante kirurgjikalë joaktivë - Implante të nyjeve të rivendoshme - Kërkesa specifike për implante të nyjeve të gjurit të rivendosshme (ISO 21536:2023)

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

General information

40.20     10 shk 2025

40.60    6 maj 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.

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
10 shk 2025

Related project

Adopted from EN ISO 21536:2024 IDENTICAL

Adopted from ISO 21536:2023 IDENTICAL

Preview

Vetëm seksionet informative të projekteve janë në dispozicion të publikut. Për të parë përmbajtjen e plotë, do t'ju duhet të krijoni një llogari. Nëse jeni anëtar, ju lutemi hyni në llogarinë tuaj duke klikuar në butonin "Identifikohu".

Login