EN ISO 21535:2024
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
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.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2023)
Dieses Dokument legt Anforderungen an Implantate für den Hüftgelenkersatz fest. Im Hinblick auf Sicherheit legt dieses Dokument Anforderungen an die vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, die Bereitstellung von Informationen durch den Hersteller und Prüfverfahren fest.
Dieses Dokument gilt für Implantate sowohl zum totalen als auch zum partiellen Hüftgelenkersatz. Es gilt für Komponenten aus metallischen und nichtmetallischen Werkstoffen.
Dieses Dokument gilt für eine Vielzahl von Hüftgelenkersatzimplantaten. Auf einige spezifische Typen von Hüftgelenkersatzimplantaten 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 klinischen Anwendung des Implantats belegt werden.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2023)
Le présent document spécifie les exigences relatives aux prothèses de l'articulation de la hanche. 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 de la hanche. 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 de la hanche. 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 umetni kolk (ISO 21535:2023)
Ta dokument določa zahteve za umetni kolk. V zvezi z varnostjo ta dokument določa zahteve za predvideno zmogljivost, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje, informacije proizvajalca in preskusne metode.
Uporablja se tako za popolne kot delne umetne kolke ter za komponente, izdelane iz kovinskih in nekovinskih materialov.
Ta dokument se uporablja za različne vrste umetnih kolkov, 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
umetni kolk (ISO 21535:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO 21535:2023)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle
Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2023)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO
21535:2023)
Ta slovenski standard je istoveten z: EN ISO 21535:2024
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 21535
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 21535:2009, EN ISO
21535:2009/A1:2016
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants
(ISO 21535:2023)
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 Hüftgelenkersatz (ISO 21535:2023)
l'articulation de la hanche (ISO 21535:2023)
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 21535:2024 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 21535:2024) 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 21535:2009, EN ISO 21535:2009/A1:2016.
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 21535:2023 has been approved by CEN as EN ISO 21535:2024 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 7206-2:2011+Amd 1:2016 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:
5.2.1 The compatibility of taper
connections is covered by 5.2.1.
7.2.2.3
The pull-off and lever off
characteristics of the heads are
covered by 7.2.2.3.
4 and 7.2.2.5 The range of motion is covered
by Clause 4 and 7.2.2.5.
7.2.2.6 The resistance to torque is
covered by 7.2.2.6.
7.2.2.10 The disassembly force is covered
by 7.2.2.10.
7.2.2.11 The fretting corrosion is covered
by 7.2.2.11.
7.2.2.12 Impingement is covered by
7.2.2.12.
7.2.2.13 and 7.2.2.14 The static and fatigue strength of
modular connections is covered
by 7.2.2.13 and 7.2.2.14.
7.2.2.15 The frictional torque of a hip
joint bearing is covered by
7.2.2.15.
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 10.1 (g) is covered by 5.2.2.
st
10.4.1 1 paragraph 7.2.2.4 10.4.1 is covered with respect to
wear of the bearings of hip
implants by 7.2.2.4 which
requires that the bearings of hip
joints shall undergo wear testing
and the wear shall be the same or
less than the wear of a reference
implant.
23.4 (s) 11.5 23.4 (s) is covered with respect
to the information for the patient
by 11.5.
11.6 23.4 (s) is covered with respect
to the information for the
surgeon by 11.6.
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 6475 ISO 6475:1989 Implants for surgery — Metal -
bone screws with
asymmetrical thread and
spherical under-surface —
Mechanical requirements and
test methods
ISO 7206-1:2008 ISO 7206-1:2008 Implants for surgery — -
Partial and total hip joint
prostheses — Part 1:
Classification and designation
of dimensions
ISO 7206-2 ISO 7206-2:2011 Implants for surgery — -
and ISO 7206- Partial and total hip joint
2:2011/Amd prostheses — Part 2:
1:2016 Articulating surfaces made of
metallic, ceramic and plastics
materials
ISO 7206-4 ISO 7206-4:2010 Implants for surgery — -
and ISO 7206- Partial and total hip joint
4:2010/Amd prostheses — Part 4:
1:2016 Determination of endurance
properties and performance
of stemmed femoral
components
ISO 7206-6 ISO 7206-6:2013 Implants for surgery — -
Partial and total hip joint
prostheses — Part 6:
Endurance properties testing
and performance
requirements of neck region
of stemmed femoral
components
ISO 7206-10 ISO 7206- Implants for surgery — -
10:2018 and ISO Partial and total hip-joint
7206- prostheses — Part 10:
10:2018/Amd Determination of resistance
1:2021 to static load of modular
femoral heads
ISO 7206-12 ISO 7206- Implants for surgery — -
12:2016 Partial and total hip joint
prostheses — Part 12:
Deformation test method for
acetabular shells
ISO 7206-13 ISO 7206- Implants for surgery — -
13:2016 and ISO Partial and total hip joint
7206- prostheses — Part 13:
13:2016/Amd Determination of resistance
1:2022 to torque of head fixation of
stemmed femoral
components
ISO 10993-1 ISO 10993- Biological evaluation of EN ISO 10993-1:2020
1:2018 medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 11491 ISO 11491:2017 Implants for surgery — -
Determination of impact
resistance of ceramic femoral
heads for hip joint prostheses
ISO 14242-1 ISO 14242- Implants for surgery — Wear -
1:2014 and ISO of total hip-joint prostheses
14242- — Part 1: Loading and
1:2014/Amd displacement parameters for
1:2018 wear-testing machines and
corresponding environmental
conditions for test
ISO 14242-2 ISO 14242- Implants for surgery — Wear -
2:2016 of total hip-joint prostheses
— Part 2: Methods of
measurement
ISO 14242-3 ISO 14242- Implants for surgery — Wear -
3:2009 and ISO of total hip-joint prostheses
14242- — Part 3: Loading and
3:2009/Amd displacement parameters for
1:2019 orbital bearing type wear
testing machines and
corresponding environmental
conditions for test
...
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