EN ISO 21536:2024
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 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 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 Informationen 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 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 21536:2023)
Ta dokument določa zahteve za kolenske proteze. V zvezi z varnostjo ta dokument določa zahteve za predvideno zmogljivost, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje, informacije proizvajalca in preskusne metode.
Ta dokument se uporablja tako za popolne kot delne kolenske proteze – z zamenjavo patelofemoralnega sklepa oziroma brez nje – ter za komponente, izdelane iz kovinskih in nekovinskih materialov.
Ta dokument se uporablja za različne vrste kolenskih protez, vendar lahko pri določenih veljajo zahteve, ki niso posebej zajete v tem dokumentu. Dodatne podrobnosti so navedene v točki 7.2.1.2.
Namen zahtev, določenih v tem dokumentu, ni v tem, da se zahteva preoblikovanje ali ponovno preskušanje vsadkov, ki se zakonito tržijo ter za katere je znana pretekla zadostna in varna klinična uporaba. Pri teh vsadkih je mogoče skladnost s tem dokumentom dokazovati s predložitvijo dokazov o njihovi zadostni in varni klinični uporabi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze (ISO 21536:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants (ISO 21536:2023)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle
Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2023)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO
21536:2023)
Ta slovenski standard je istoveten z: EN ISO 21536:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21536
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 21536:2009 EN ISO
21536:2009/A1:2014
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for knee-joint replacement implants
(ISO 21536:2023)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Spezielle Anforderungen an Implantate
relatives aux implants de remplacement de für den Kniegelenkersatz (ISO 21536:2023)
l'articulation du genou (ISO 21536:2023)
This European Standard was approved by CEN on 4 June 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21536:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 21536:2024) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2025, and conflicting national standards shall
be withdrawn at the latest by January 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21536:2009, EN ISO 21536:2009/A1:2014.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21536:2023 has been approved by CEN as EN ISO 21536:2024 without any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to
be covered
This European Standard has been prepared under a Commission’s standardization request
“M/575” to provide one voluntary means of conforming to the General Safety and Performance
Requirements of Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation
(EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this
standard can differ from the scope of the European Regulation that it supports. As the scope of the
applicable regulatory requirements differ from nation to nation and region to region, the standard
can only support European regulatory requirements to the extent of the scope of the European
regulation for medical devices (EU) 2017/745).
For application of this European standard under Regulation (EU) 2017/745,
1 it is clarified that the third paragraph of the scope and the related subclause 7.2.1.2 are solely intended
to point out that additional testing not specified in this document can be required to ensure the safety
and efficacy of implants for which failure modes exist which were unknown at the time of drafting of
this document;
2 it is clarified that the fourth paragraph of the scope and related language in the first paragraphs of
Clauses 4, 5, 6 and 7 are intended to avoid unnecessary re-design or re-testing of implants which are
currently legally marketed in the European Union;
3 it is recognized that the normatively referenced ISO 7207-2:2011+Amd 1:2016+Amd 2:2020 itself
includes a reference to the withdrawn ISO 4288:1996 which has been replaced by ISO 21920-3:2021
and for application of this European standard under Regulation (EU) 2017/745 ISO 21920-3:2021 shall
be used instead of ISO 4288:1996;
4 it is recognized that the normatively referenced ISO 10993-1 includes a dated reference to ISO
14971:2007 which is outdated and for application of this European standard under Regulation (EU)
2017/745 the most recent European version EN ISO 14971:2019 + A11:2021 shall be used;
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical investigations,
clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/745
10.1 (c) 10.1 (c) is covered as follows:
7.2.2.4 The durability of the
patellofemoral joint is covered
by 7.2.2.4.
7.2.2.5 The attachment of the tibial
insert to the tibial tray is
covered by 7.2.2.5.
7.2.2.6 The attachment of the patella
insert to the patellar tray is
covered by 7.2.2.6.
7.2.2.7 The resistance to dynamic
disassociation of mobile-
bearing knee components
from the tibial tray is covered
by 7.2.2.7.
7.2.2.9
The dislocation of mobile-
bearing knees is covered by
7.2.2.10
7.2.2.9.
The static and fatigue strength
of modular connections is
7.2.2.12
covered by 7.2.2.10.
The patellofemoral resistance
to lateral subluxation is
7.2.2.13 and 7.2.2.14
covered by 7.2.2.12.
The tibio-femoral and the
patella-femoral contact area
and pressure are covered by
7.2.2.13 and 7.2.2.14.
10.1 (f) 7.2.2 (all subclauses) 10.1 (f) is covered with the
exception of “ductility” by
7.2.2 (all subclauses).
10.1 (g) 5.2.2 and 5.2.3 10.1 (g) is covered with
respect to the surface finish by
5.2.2 and 5.2.3.
st
10.4.1 1 paragraph 7.2.2.2 and 7.2.2.3 10.4.1 is covered with respect
to wear of the bearings of
knee implants by 7.2.2.2 and
7.2.2.3 which require that the
bearings of knee joints shall
undergo wear testing and the
wear shall be the same or less
than the wear of a reference
implant.
23.2 (b) 11.2 23.2 (b) is covered with
respect to product type and
dimensions by 11.2.
23.4 (s) 11.5 23.4 (s) is covered with
respect to the information for
the patient by 11.5.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard Edition
European Standard
Edition
ISO 5834-1 ISO 5834-1:2019 Implants for surgery — Ultra- -
high-molecular-weight
polyethylene — Part 1:
Powder form
ISO 7207-1:2007 ISO 7207-1:2007 Implants for surgery — -
Components for partial and
total knee joint prostheses —
Part 1: Classification,
definitions and designation of
dimensions
ISO 7207-2 ISO 7207-2:2011 Implants for surgery — -
and ISO 7207- Components for partial and
2:2011/Amd 1:2016 total knee joint prostheses —
and ISO 7207- Part 2: Articulating surfaces
2:2011/Amd 2:2020 made of metal, ceramic and
plastics materials
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 14243-1 ISO 14243-1:2009 Implants for surgery — Wear -
and ISO 14243- of total knee-joint prostheses
1:2009/Amd 1:2020 — Part 1: Loading and
displacement parameters for
wear-testing machines with
load control and
corresponding environmental
conditions for test
ISO 14243-2 ISO 14243-2:2016 Implants for surgery — Wear -
of total knee-joint prostheses
— Part 2: Methods of
measurement
ISO 14243-3 ISO 14243-3:2014 Implants for surgery — Wear -
and ISO 14243- of total knee-joint prostheses
3:2014/Amd 1:2020 — Part 3: Loading and
displacement parameters for
wear-testing machines with
displacement control and
corresponding environmental
conditions for test
ISO 14243-5 ISO 14243-5:2019 Implants for surgery — Wear -
of total knee prostheses —
Part 5: Durability
performance of the
patellofemoral joint
ISO 14630 ISO 14630:2012 Non-active surgical implants EN ISO 14630:2012
— General requirements
ISO 14879-1 ISO 14879-1:2020 Implants for surgery — Total -
knee-joint prostheses — Part
1: Determination of
endurance properties of knee
tibial trays
ISO 21534:2007 ISO 21534:2007 Non-active surgical implants EN ISO 21534:2009
— Joint replacement implants
— Particular requirements
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained
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