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ISO 21536:2023

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
5 korr 2023

General information

60.60     5 korr 2023

ISO

ISO/TC 150/SC 4

International Standard

11.040.40  

anglisht   frëngjisht  

Buying

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 21536:2007

WITHDRAWN
ISO 21536:2007/Amd 1:2014

NOW

PUBLISHED
ISO 21536:2023
60.60 Standard published
5 korr 2023

National adoptions

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

40.20 DIS ballot initiated: 12 weeks

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