FprEN ISO 21536

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

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.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle Anforderungen an Implantate für den Kniegelenkersatz (ISO/FDIS 21536:2023)

Dieses Dokument legt Anforderungen an Implantate für den Kniegelenkersatz fest. Im Hinblick auf Sicherheit legt dieses Dokument Anforderungen an vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, Bereitstellung von Informa¬tionen durch den Hersteller und für Prüfverfahren fest.
Dieses Dokument gilt sowohl für totale als auch für partielle Kniegelenkersatzimplantate. Es gilt für diese Prothesen sowohl mit als auch ohne Ersatz des patellafemoralen Gelenks. Es gilt für Komponenten aus metallischen und nichtmetallischen Werkstoffen.
Dieses Dokument gilt für eine Vielzahl von Kniegelenkersatzimplantaten. Auf einige spezielle Typen von Kniegelenkersatzimplantaten können jedoch bestimmte Überlegungen zutreffen, die in diesem Dokument nicht spezifisch abgedeckt sind. Weitere Einzelheiten sind in 7.2.1.2 angegeben.
Hinter den in diesem Dokument festgelegten Anforderungen steht nicht die Absicht, eine Neukonstruktion oder erneute Prüfung von Implantaten zu verlangen, die rechtmäßig in Verkehr gebracht wurden und die über eine Vorgeschichte der ausreichenden und sicheren klinischen Anwendung verfügen. Die Übereinstimmung solcher Implantate mit diesem Dokument kann durch den Nachweis der ausreichenden und sicheren klini¬schen Anwendung des Implantats belegt werden.

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO/FDIS 21536:2023)

Le présent document spécifie les exigences relatives aux prothèses de l'articulation du genou. En matière de sécurité, le présent document fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant ainsi que des méthodes d'essai.
Le présent document s'applique à la fois aux implants de remplacement total et partiel de l'articulation du genou. Il s'applique à ces remplacements avec et sans remplacement de l'articulation fémoro-patellaire. Il s'applique aux composants fabriqués en matériaux métalliques et non métalliques.
Le présent document s'applique à une grande variété d'implants, mais certaines considérations, non spécifiquement couvertes dans le présent document, peuvent être applicables à certains types spécifiques d'implants de remplacement de l'articulation du genou. Voir 7.2.1.2 pour plus de détails.
Les exigences spécifiées dans le présent document n'ont pas pour but d'exiger une nouvelle conception ou de nouveaux essais sur des implants qui ont été légalement mis sur le marché et pour lesquels il existe un historique d'utilisation clinique suffisante et sans danger. Pour ces implants, la conformité au présent document peut être démontrée en fournissant la preuve d'une utilisation clinique suffisante et sans danger de l'implant.

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za kolenske proteze (ISO/FDIS 21536:2023)

General Information

• Status: Not Published
• Publication Date: 03-Aug-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 04-Jun-2023
• Completion Date: 04-Jun-2023
• Directive: 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
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: kSIST FprEN ISO 21536:2023 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)

Relations

• Revises: EN ISO 21536:2009 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
• Effective Date: 18-Jan-2023
• Revises: EN ISO 21536:2009/A1:2014 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
• Effective Date: 13-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 21536:2021
01-oktober-2021
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze (ISO/DIS 21536:2021)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants (ISO/DIS 21536:2021)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz (ISO/DIS 21536:2021)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO/DIS
21536:2021)
Ta slovenski standard je istoveten z: prEN ISO 21536
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 21536:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 21536:2021

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oSIST prEN ISO 21536:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21536
ISO/TC 150/SC 4 Secretariat: BSI
Voting begins on: Voting terminates on:
2021-07-22 2021-10-14
Non-active surgical implants — Joint replacement implants
— Specific requirements for knee-joint replacement
implants
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 21536:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

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oSIST prEN ISO 21536:2021
ISO/DIS 21536:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 21536:2021
ISO/DIS 21536:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 5
5 Design attributes . 6
5.1 General . 6
5.2 Thickness of knee joint components.
...