ISO 21535:2023
(Main)Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
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.
Implants chirurgicaux non actifs — Implants de remplacement d'articulation — Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche
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.
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INTERNATIONAL ISO
STANDARD 21535
Third edition
2023-07
Non-active surgical implants —
Joint replacement implants —
Specific requirements for hip-joint
replacement implants
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation de la hanche
Reference number
ISO 21535:2023(E)
© ISO 2023
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ISO 21535:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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Email: copyright@iso.org
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Published in Switzerland
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ISO 21535:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Intended performance .7
5 Design attributes .7
5.1 General . 7
5.2 Tolerances and dimensions . 8
5.2.1 Tolerances and dimensions of taper connections . 8
5.2.2 Tolerances on diameters of articulating surfaces, sphericity of articulating
surfaces and surface finish of articulating surfaces . 8
5.3 Thickness of acetabular components, bipolar heads and dual mobility heads . 9
5.3.1 General . 9
5.3.2 Thickness of UHMWPE in acetabular components, bipolar heads and dual
mobility heads . 9
5.3.3 Thickness of metal and ceramic acetabular shell and acetabular liner
components, bipolar heads, and dual mobility heads . 10
6 Materials .11
7 Design evaluation .11
7.1 General . 11
7.2 Pre-clinical evaluation . .12
7.2.1 General .12
7.2.2 Test methods and performance requirements . 14
7.3 Clinical investigation . 20
7.4 Post market surveillance . 20
8 Manufacture .20
9 Sterilization .20
10 Packaging.21
11 Information to be supplied by the manufacturer .21
11.1 General . 21
11.2 Product type and dimensions . 21
11.3 Structural and functional compatibility of components . 21
11.4 Marking . 21
11.5 Information for the patient . 22
11.6 Information for the surgeon . 22
11.7 Electronic instructions for use .22
Annex A (normative) Evaluation of the range of relative angular motion of the femoral and
acetabular components of a total hip replacement .23
Bibliography .26
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ISO 21535:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 4, Bone and joint replacements, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 21535:2007), which has been technically
revised. It also incorporates the Amendment ISO 21535:2007/Amd 1:2016.
The main changes are as follows:
— The scope has been expanded to specify more precisely the hip joint replacement types which are
the subject of this document. Also, the scope now clarifies the requirements for implants which have
been legally marketed and for which there is a history of sufficient and safe clinical use.
— The number of normative references has been expanded, including the addition of several ASTM
standards.
— Several new definitions have been added, including: bipolar femoral hip and bipolar femoral hip joint
replacement, bipolar femoral component, constrained hip and constrained hip joint replacement,
dual mobility head and dual mobility femoral component, dual mobility hip and dual mobility hip
joint replacement, femoral head, reference implant, resurfacing hip joint replacement, sufficient and
safe clinical use, ultra-high molecular weight polyethylene and UHMWPE, and worst case.
— The design attributes to be taken into account have been specified in Clause 5. The requirements
for tolerances, dimensions and thickness of various hip components made from plastic, metal and
ceramic have been expanded.
— Several new general requirements have been added in 7.2.1, which specify
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ISO 21535:2023(E)
a) the circumstances when a test can be omitted,
b) the testing of the worst case,
c) the processes to be followed when no performance requirement has been specified, and
d) the processes to be followed when a performance requirement has been specified but has not
been met.
— The number of pre-clinical evaluations (bench tests) to be performed has been greatly increased
in 7.2.2. For some of the tests, a performance requirement has been specified. For some of the
tests, no performance requirement has been specified, and, in these cases, a new requirement has
been added, namely the requirement to demonstrate that the performance of the implant under
evaluation is the same or better than that of a reference implant. If no reference implant exists, a
sequence of alternative options has been specified. These alternative options are also available in
the case where there is a performance requirement, which is not met by the implant being tested.
— A new clinical investigation subclause has been added in 7.3, with several requirements which
specify the circumstances in which a clinical investigation can be required.
— A new post-market surveillance subclause has been added in 7.4, which references the requirements
in ISO 21534:2007, 7.4.
— A warning for the surgeon about the consequences of component malposition or the use of specific
components which can decrease joint range of motion has been added in 11.6.
— A note has been added in 11.7 which states that in some jurisdictions there is the option to provide
the instructions for use in electronic instead of paper format.
— All the figures have been revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO 21535:2023(E)
Introduction
There are three levels of standards dealing with non-active surgical implants.
These are as follows, with level 1 being the highest:
— level 1: general requirements for non-active surgical implants and instrumentation used in
association with implants;
— level 2: particular requirements for families of non-active surgical implants;
— level 3: specific requirements for types of non-active surgical implant.
This document is a level 3 standard and contains requirements applying specifically to hip joint
replacements.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It
also indicates that there are additional requirements in the level 2 and level 3 standards.
The level 2 standards apply to more restricted sets or families of implants such as those designed for
use in osteosynthesis, cardiovascular surgery or joint replacement. For joint replacement implants, the
level 2 standard is ISO 21534.
To address all requirements, it is recommended that a standard of the lowest available level be consulted
first.
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INTERNATIONAL STANDARD ISO 21535:2023(E)
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5834-1, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 6475, Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface
— Mechanical requirements and test methods
ISO 7206-1:2008, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and
designation of dimensions
ISO 7206-2, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces
made of metallic, ceramic and plastics materials
ISO 7206-4, Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of
endurance properties and performance of stemmed femoral components
ISO 7206-6, 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, Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of
resistance to static load of modular femoral heads
ISO 7206-12, Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test
method for acetabular shells
ISO 7206-13, Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of
resistance to torque of head fixation of stemmed femoral components
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ISO 21535:2023(E)
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11491, Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip
joint prostheses
ISO 14242-1, Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement
parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-2, Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ISO 14242-3, Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement
parameters for orbital bearing type wear testing machines and corresponding environmental conditions
for test
ISO 14242-4, Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses
under variations in component positioning which results in direct edge loading
ISO 14630, Non-active surgical implants — General requirements
ISO 21534:2007, Non-active surgical implants — Joint replacement implants — Particular requirements
ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated
Form for Surgical Implants
ASTM F1820, Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular
Devices
ASTM F1875, Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper Interface
ASTM F2009, Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of
Modular Prostheses
ASTM F2033, Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces
Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2345, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads
ASTM F2580, Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip
Prosthesis
ASTM F2582, Standard Test Method for Impingement of Acetabular Prostheses
ASTM F3018, Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip
Resurfacing Arthroplasty Devices
ASTM F3047M, Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
ASTM F3090, Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
ASTM F3143, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Replacement Bearings Under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3446, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Implants Using an Anatomical Motion Hip Simulator
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ISO 21535:2023(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7206-1, ISO 7206-2,
ISO 7206-10, ISO 14630, ISO 21534 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
acetabular component
implant intended to be fixed to the prepared biological acetabulum
Note 1 to entry: The acetabular component can be of monobloc or modular construction. If modular, typically
there can be two sub-components, each fulfilling a different function: one is the bearing surface and the other
provides the means of fixation to the prepared biological acetabulum. The bearing surface is also referred to as
the liner (or the insert) and the other sub-component is also referred to as the shell or cup.
3.2
bipolar femoral hip
bipolar femoral hip joint replacement
type of partial hip joint replacement (3.12) consisting of a bipolar head (3.3) and a femoral component
(3.7)
3.3
bipolar head
bipolar femoral component
component of a bipolar femoral hip (3.2) with a concave (inner) surface intended to articulate with
the spherical head of the femoral component (3.7) and a convex (outer) spherical surface intended to
articulate with the biological acetabulum
Note 1 to entry: The bipolar head can be a monobloc component (3.11) or a modular component (3.10).
Note 2 to entry: The above definition for bipolar femoral component above is compatible with the definition
included in ISO 7206-1:2008, 3.1, but it includes additional information for clarity.
3.4
constrained hip
constrained hip joint replacement
type of total hip joint replacement (3.16) intended to prevent hip dislocation in more than one anatomic
plane, which consists of a femoral component (3.7) and an acetabular component (3.1), which are
connected across the joint
Note 1 to entry: A dual mobility constrained hip is a type of constrained hip which consists of a femoral component
(3.7), a dual mobility head (3.5) and a modular constrained acetabular component, which are connected across the
joint. This type of constrained hip is also called a “tripolar hip”. Although the term “tripolar” is used to describe
the construct, there are only two bearings.
3.5
dual mobility head
dual mobility femoral component
component of a total hip joint replacement (3.16) with a concave (inner) surface intended to articulate
with the spherical head of the femoral component (3.7) and a convex (outer) spherical surface intended
to articulate with an acetabular component (3.1)
Note 1 to entry: The dual mobility head can be a monobloc component (3.11) or a modular component (3.10).
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ISO 21535:2023(E)
3.6
dual mobility hip
dual mobility hip joint replacement
type of total hip joint replacement (3.16) consisting of a femoral component (3.7), dual mobility head (3.5)
and an acetabular component (3.1)
3.7
femoral component
part of a total hip joint replacement (3.16) or a partial hip joint replacement (3.12) which is intended to be
fixed to the proximal femur
Note 1 to entry: The femoral component fulfils two different functions: one is to provide the bearing surface and
the other is to provide the means of fixation to the proximal femur.
Note 2 to entry: The femoral component can be monobloc or modular. If modular, typically there are two sub-
components, each fulfilling a different function: one is the modular femoral head (3.8) and the other is the
modular femoral stem. A modular femoral stem can itself be modular, consisting of a single or multi-component
modular femoral stem and a single or multi-component modular femoral neck and taper connection(s).
Note 3 to entry: The femoral component of a resurfacing hip joint replacement (3.14) can also be referred to as the
femoral cap.
3.8
femoral head
part of a total hip joint replacement (3.16) or a partial hip joint replacement (3.12) which articulates with:
a) the natural acetabulum or a bipolar head (3.3), in the case of a partial hip joint replacement (3.12),
and
b) the acetabular component (3.1) or a dual mobility head (3.5), in the case of a total hip joint replacement
(3.16)
3.9
hip joint replacement
implant used to replace one or both of the articulating surfaces of the hip joint
Note 1 to entry: An implant intended to replace only the femoral articulating surface of the hip joint is referred to
as partial hip joint replacement (3.12).
Note 2 to entry: An implant intended to replace the femoral and acetabular surfaces of the hip joint is referred to
as total hip joint replacement (3.16).
Note 3 to entry: The term hip arthroplasty refers to the act of implanting a hip joint replacement.
3.10
modular component
femoral component (3.7) or acetabular component (3.1) that consists of two or more sub-components
Note 1 to entry: A modular component can be supplied preassembled or as separate components to be assembled
by the user.
3.11
monobloc component
component that consists of a single part with no modularity
3.12
partial hip joint replacement
implant comprising a femoral component (3.7) intended to replace only the femoral articulating surface
of the hip joint
Note 1 to entry: A modular partial hip joint replacement incorporates either a bipolar or a unipolar head.
Note 2 to entry: The term hip hemiarthroplasty refers to the act of implanting a partial hip joint replacement.
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ISO 21535:2023(E)
Note 3 to entry: A partial hip joint replacement is sometimes referred to as a “hemi”.
3.13
reference implant
legally-marketed implant which, when compared to the implant under evaluation, satisfies both of the
following conditions:
a) it has the same intended use, similar materials and a similar design with regard to the specific
dimensional or performance criteria under evaluation to address the same clinical and technical
requirements, and
b) there is evidence of successful clinical use in sufficient numbers; for a sufficient period of time; and
at a minimum, without known or reasonably-known evidence of design or performance-related
recalls with regard to the specific dimensional or performance criteria under evaluation
Note 1 to entry: The term “reference” is not intended to imply that the implant under evaluation and the
reference implant are “equivalent” or that the reference implant is a “predicate” implant. This is because for some
regulatory authorities, the terms “equivalent” and “predicate” have a meaning which is beyond that intended by
the term “reference” as used in this document.
Note 2 to entry: A reference implant is the comparison implant for dimensional or performance parameter(s)
under evaluation. Other characteristics of the reference implant shall be considered in order for the comparison
to be suitable, as in some situations there can be cross-effects. Ideally, for the majority of dimensional and
performance parameters, a single reference implant should be used for comparison to the implant under
evaluation. However, more than one reference implant may be used for comparison purposes, with adequate
scientific and clinical justification.
Note 3 to entry: Some regulatory authorities can require that a reference implant is one that is legally marketed
in their own country or jurisdiction. This fact can be taken into account when selecting a reference implant for
the purposes of this document.
Note 4 to entry: There is no agreed upon interpretation for what constitutes “sufficient numbers” or a “sufficient
period of time” in the above definition. Typically, a determination of what constitutes “sufficient numbers” and a
“sufficient period of time” is demonstrated by using statistical methods and clinical judgement in the evaluation
of implant performance.
Note 5 to entry: A justification for a “similar material” may include information that although the materials are
not the same, the material(s) used for the implant under evaluation can be shown to perform similarly with
regard to th
...
NORME ISO
INTERNATIONALE 21535
Troisième édition
2023-07
Implants chirurgicaux non actifs —
Implants de remplacement
d'articulation — Exigences
spécifiques relatives aux implants de
remplacement de l'articulation de la
hanche
Non-active surgical implants — Joint replacement implants —
Specific requirements for hip-joint replacement implants
Numéro de référence
ISO 21535:2023(F)
© ISO 2023
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ISO 21535:2023(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2023
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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Publié en Suisse
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ISO 21535:2023(F)
Sommaire Page
Avant-propos .iv
Introduction . vi
1 Domaine d'application .1
2 Références normatives .1
3 Termes et définitions . 3
4 Performances prévues . 7
5 Attributs de conception .8
5.1 Généralités . 8
5.2 Tolérances et dimensions . 9
5.2.1 Tolérances et dimensions des raccordements coniques . 9
5.2.2 Tolérances relatives au diamètre des surfaces articulaires, à la sphéricité
des surfaces articulaires et à l'état de surface des surfaces articulaires . 9
5.3 Épaisseur des composants acétabulaires, des têtes bipolaires et des inserts mobiles . 10
5.3.1 Généralités . 10
5.3.2 Épaisseur du PE-UHMW dans les composants acétabulaires, les têtes
bipolaires et les inserts mobiles . 10
5.3.3 Épaisseur de la cupule acétabulaire en métal et en céramique et des
composants d'insert acétabulaire, têtes bipolaires, et inserts mobiles . 11
6 Matériaux .12
7 Évaluation de la conception .13
7.1 Généralités . 13
7.2 Évaluation préclinique . 13
7.2.1 Généralités .13
7.2.2 Méthodes d'essai et exigences relatives à la performance .15
7.3 Investigation clinique . 21
7.4 Surveillance après mise sur le marché. 22
8 Fabrication .22
9 Stérilisation .22
10 Emballage .22
11 Informations à fournir par le fabricant .22
11.1 Généralités .22
11.2 Type et dimensions du produit .23
11.3 Compatibilité structurelle et fonctionnelle des composants .23
11.4 Marquage . 23
11.5 Informations à fournir au patient . 23
11.6 Informations à fournir au chirurgien . 24
11.7 Instructions d'utilisation au format électronique . 24
Annexe A (normative) Évaluation de l'amplitude de mouvement angulaire relatif des
composants fémoraux et acétabulaires d'une prothèse totale de la hanche .25
Bibliographie .28
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ISO 21535:2023(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner
l’utilisation d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité
et à l’applicabilité de tout droit de brevet revendiqué à cet égard. À la date de publication du présent
document, l’ISO n'avait pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa
mise en application. Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent
document que des informations plus récentes sont susceptibles de figurer dans la base de données de
brevets, disponible à l'adresse www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne
pas avoir identifié tout ou partie de tels droits de propriété.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 150, Implants chirurgicaux, sous-
comité SC 4, Prothèses des os et des articulations, en collaboration avec le comité technique CEN/TC 285,
Implants chirurgicaux non actifs, du Comité européen de normalisation (CEN), conformément à l'Accord
de coopération technique entre l'ISO et le CEN (Accord de Vienne).
Cette troisième édition annule et remplace la deuxième édition (ISO 21535:2007), qui a fait l'objet d'une
révision technique. Elle incorpore également l'Amendement ISO 21535:2007/Amd 1:2016.
Les principales modifications sont les suivantes:
— le domaine d'application a été élargi pour spécifier plus précisément les types de prothèses
de l'articulation de la hanche qui sont traités dans le présent document. En outre, le domaine
d'application clarifie désormais les exigences relatives aux implants qui ont été légalement mis sur
le marché et pour lesquels il existe un historique d'utilisation clinique suffisante et sans danger;
— le nombre de références normatives a été élargi, notamment par l'ajout de plusieurs normes ASTM;
— plusieurs nouvelles définitions ont été ajoutées, y compris les suivantes: hanche fémorale bipolaire
et prothèse de l'articulation de la hanche fémorale bipolaire, composant fémoral bipolaire, hanche
contrainte et prothèse contrainte de l'articulation de la hanche, tête double mobilité et composant
fémoral à double mobilité, hanche à double mobilité et prothèse de l'articulation de la hanche à
double mobilité, tête fémorale, implant de référence, prothèse de resurfaçage de l'articulation de la
hanche, utilisation clinique suffisante et sans danger, polyéthylène à très haute masse moléculaire
et PE-UHMW, et cas le plus défavorable;
iv
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ISO 21535:2023(F)
— les attributs de conception à prendre en compte ont été précisés à l'Article 5. Les exigences portant
sur les tolérances, les dimensions et l'épaisseur des différents composants de hanche en plastique,
en métal et en céramique ont été élargies;
— plusieurs nouvelles exigences générales ont été ajoutées en 7.2.1, qui spécifient:
a) les circonstances dans lesquelles un essai peut être omis;
b) l'essai du cas le plus défavorable;
c) les processus à suivre lorsqu'aucune exigence de performance n'a été spécifiée; et
d) les processus à suivre lorsqu'une exigence de performance a été spécifiée mais n'a pas été
satisfaite;
— le nombre d'évaluations précliniques (essais au banc) à réaliser a été considérablement augmenté
en 7.2.2. Pour certains de ces essais, une exigence de performance a été spécifiée. Pour certains de
ces essais, aucune exigence de performance n'a été spécifiée et, dans ces cas, une nouvelle exigence
a été ajoutée, à savoir une exigence pour démontrer que la performance de l'implant évalué est égale
ou supérieure à celle d'un implant de référence. En l'absence d'implant de référence, une séquence
d'options alternatives a été spécifiée. Ces options alternatives sont également applicables dans le
cas où une exigence de performance existe mais n'est pas satisfaite par l'implant soumis à essai;
— un nouveau paragraphe relatif à l'investigation clinique a été ajouté en 7.3, comprenant plusieurs
exigences qui spécifient les circonstances dans lesquelles une investigation clinique peut être
requise;
— un nouveau paragraphe relatif à la surveillance après mise sur le marché a été ajoutée en 7.4, faisant
référence aux exigences de l'ISO 21534:2007, 7.4;
— un avertissement à l'intention du chirurgien, sur les conséquences du mauvais positionnement des
composants ou de l'utilisation de composants spécifiques susceptibles de réduire l'amplitude de
mouvement de l'articulation, a été ajouté en 11.6;
— une note a été ajoutée en 11.7, indiquant que dans certaines juridictions, il est possible de fournir les
instructions d'utilisation sous forme électronique plutôt que sur papier;
— toutes les figures ont été révisées.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l'adresse www.iso.org/fr/members.html.
v
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ISO 21535:2023(F)
Introduction
Les normes relatives aux implants chirurgicaux non actifs sont réparties en trois niveaux.
Ces niveaux sont les suivants, le niveau 1 étant le plus élevé:
— niveau 1: exigences générales relatives aux implants chirurgicaux non actifs et aux instruments
utilisés en association avec les implants;
— niveau 2: exigences particulières relatives aux familles d'implants chirurgicaux non actifs;
— niveau 3: exigences spécifiques à certains types d'implants chirurgicaux non actifs.
Le présent document est de niveau 3 et énonce des exigences spécifiquement applicables aux prothèses
de l'articulation de la hanche.
L'ISO 14630, relevant du niveau 1, contient des exigences qui s'appliquent à tous les implants
chirurgicaux non actifs. Elle indique également que des exigences supplémentaires sont stipulées dans
les normes de niveaux 2 et 3.
Les normes de niveau 2 s'appliquent à des séries ou à des familles plus restreintes d'implants, tels que
ceux destinés à être utilisés en ostéosynthèse, en chirurgie cardiovasculaire ou en arthroplastie. Pour
les implants de remplacement des articulations, la norme de niveau 2 est l’ISO 21534.
Pour couvrir toutes les exigences, il est préférable de consulter en premier lieu la norme du niveau le
plus bas existant.
vi
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NORME INTERNATIONALE ISO 21535:2023(F)
Implants chirurgicaux non actifs — Implants de
remplacement d'articulation — Exigences spécifiques
relatives aux implants de remplacement de l'articulation
de la hanche
1 Domaine d'application
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.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu'ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l'édition citée s'applique.
Pour les références non datées, la dernière édition du document de référence s'applique (y compris les
éventuels amendements).
ISO 5834-1, Implants chirurgicaux — Polyéthylène à très haute masse moléculaire — Partie 1: Produits
sous forme de poudre
ISO 6475, Implants chirurgicaux — Vis métalliques à filetage asymétrique et à embase sphérique pour os
— Caractéristiques mécaniques et méthodes d'essai
ISO 7206-1:2008, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche —
Partie 1: Classification et désignation des dimensions
ISO 7206-2, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche — Partie
2: Surfaces articulaires constituées de matériaux métalliques, céramiques et plastiques
ISO 7206-4, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche — Partie
4: Détermination des propriétés d'endurance et des performances des tiges fémorales
ISO 7206-6, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche — Partie
6: Exigences de performance et essais des propriétés d'endurance de la région du col des tiges fémorales
ISO 7206-10, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche —
Partie 10: Détermination de la résistance à la charge statique de têtes fémorales modulaires
1
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ISO 21535:2023(F)
ISO 7206-12, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche —
Partie 12: Méthode d’essai de déformation des cupules acétabulaires
ISO 7206-13, Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche —
Partie 13: Détermination de la résistance au couple de la fixation des têtes des tiges fémorales
ISO 10993-1, Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais au sein d'un
processus de gestion du risque
ISO 11491, Implants chirurgicaux — Détermination de la résistance à l'impact des têtes de fémur en
céramique pour les prothèses de la hanche
ISO 14242-1, Implants chirurgicaux — Usure des prothèses totales de l'articulation de la hanche — Partie
1: Paramètres de charge et de déplacement pour machines d'essai d'usure et conditions environnementales
correspondantes d'essai
ISO 14242-2, Implants chirurgicaux — Usure des prothèses totales de l'articulation de la hanche — Partie
2: Méthodes de mesure
ISO 14242-3, Implants chirurgicaux — Usure des prothèses totales de l'articulation de la hanche — Partie
3: Paramètres de charge et de déplacement pour machines d'essai d'usure du type orbital de maintien et
conditions environnementales correspondantes d'essai
ISO 14242-4, Implants chirurgicaux — Usure des prothèses totales de l'articulation de la hanche — Partie 4:
Essai des prothèses de hanche par variation du positionnement des composants pour induire un chargement
direct de bord
ISO 14630, Implants chirurgicaux non actifs — Exigences générales
ISO 21534:2007, Implants chirurgicaux non actifs — Implants de remplacement d'articulation — Exigences
particulières
ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated
Form for Surgical Implants
ASTM F1820, Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular
Devices
ASTM F1875, Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper Interface
ASTM F2009, Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of
Modular Prostheses
ASTM F2033, Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces
Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2345, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads
ASTM F2580, Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip
Prosthesis
ASTM F2582, Standard Test Method for Impingement of Acetabular Prostheses
ASTM F3018, Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip
Resurfacing Arthroplasty Devices
ASTM F3047M, Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
ASTM F3090, Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
2
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ISO 21535:2023(F)
ASTM F3143, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Replacement Bearings Under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3446, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Implants Using an Anatomical Motion Hip Simulator
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions de l’ISO 7206-1, l’ISO 7206-2,
l’ISO 7206-10, l’ISO 14630 et l’ISO 21534, ainsi que les suivants s'appliquent.
L'ISO et l'IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l'adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l'adresse https:// www .electropedia .org/
3.1
composant acétabulaire
implant destiné à être fixé dans l'acétabulum biologique préparé
Note 1 à l'article: Le composant acétabulaire peut être monobloc ou modulaire. S'il est modulaire, il peut y avoir
deux sous-composants, chacun remplissant une fonction différente: l'un est la surface articulaire et l'autre
fournit les moyens de fixation à l'acétabulum biologique préparé. La surface articulaire est également appelée
«insert» et l'autre sous-composant est également appelé «cupule».
3.2
hanche fémorale bipolaire
prothèse de l'articulation de la hanche fémorale bipolaire
type de prothèse partielle de l'articulation de la hanche (3.12) composé d'une tête bipolaire (3.3) et d'un
composant fémoral (3.7)
3.3
tête bipolaire
composant fémoral bipolaire
composant de la hanche fémorale bipolaire (3.2) ayant une surface (intérieure) concave qui s'articule
sur la tête sphérique du composant fémoral (3.7) et une surface (extérieure) sphérique convexe qui
s'articule sur l'acétabulum biologique
Note 1 à l'article: La tête bipolaire peut être un composant monobloc (3.11) ou un composant modulaire (3.10).
Note 2 à l'article: La définition ci-dessus pour le composant fémoral bipolaire est compatible avec la définition de
l'ISO 7206-1:2008, 3.1, mais elle comprend des informations supplémentaires par souci de clarté.
3.4
hanche contrainte
prothèse contrainte de l'articulation de la hanche
type de prothèse totale de l'articulation de la hanche (3.16) destiné à prévenir la luxation de la hanche
dans plus d'un plan anatomique et constitué d'un composant fémoral (3.7) et d'un composant acétabulaire
(3.1), qui sont reliés à travers l'articulation
Note 1 à l'article: Une hanche contrainte à double mobilité est un type de hanche contrainte composé d'un
composant fémoral (3.7), d'une tête double mobilité (3.5), et d'un composant acétabulaire modulaire contraint,
qui sont reliés à travers l'articulation. Ce type de hanche contrainte est également appelé «hanche tripolaire».
Bien que le terme «tripolaire» soit utilisé pour décrire la structure, celle-ci ne comporte que deux surfaces
articulaires.
3
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ISO 21535:2023(F)
3.5
tête double mobilité
composant fémoral à double mobilité
composant de prothèse totale de l'articulation de la hanche (3.16) ayant une surface (intérieure) concave
qui s'articule sur la tête sphérique du composant fémoral (3.7) et une surface (extérieure) sphérique
convexe qui s'articule sur un composant acétabulaire (3.1)
Note 1 à l'article: La tête double mobilité peut être un composant monobloc (3.11) ou un composant modulaire
(3.10).
3.6
hanche à double mobilité
prothèse de l'articulation de la hanche à double mobilité
type de prothèse totale de l'articulation de la hanche (3.16) constituée d'un composant fémoral (3.7),
d'une tête double mobilité (3.5) et d'un composant acétabulaire (3.1)
3.7
composant fémoral
partie d'une prothèse totale de l'articulation de la hanche (3.16) ou d'une prothèse partielle de l'articulation
de la hanche (3.12), destinée à être fixée sur le fémur proximal
Note 1 à l'article: Le composant fémoral remplit deux fonctions différentes: la première est de fournir la surface
articulaire, la seconde est de fournir des moyens de fixation au fémur proximal.
Note 2 à l'article: Le composant fémoral peut être monobloc ou modulaire. S'il est modulaire, il existe
généralement deux sous-composants, chacun remplissant une fonction différente: le premier est la tête fémorale
(3.8) modulaire et l'autre est la tige fémorale modulaire. Une tige fémorale modulaire peut elle-même être
modulaire et être composée d'une tige fémorale modulaire à un ou plusieurs composants et d'un col fémoral
modulaire à un ou plusieurs composants et une ou plusieurs jonctions coniques.
Note 3 à l'article: Le composant fémoral d'une prothèse de resurfaçage d'articulation de la hanche (3.14) peut
également être appelé «calotte fémorale».
3.8
tête fémorale
partie d'une prothèse totale de l'articulation de la hanche (3.16) ou d'une prothèse partielle de l'articulation
de la hanche (3.12) qui s'articule avec:
a) l'acétabulum naturel ou une tête bipolaire (3.3), dans le cas d'une prothèse partielle de l'articulation
de la hanche (3.12); et
b) le composant acétabulaire (3.1) ou une tête double mobilité (3.5), dans le cas d'une prothèse totale de
l'articulation de la hanche (3.16).
3.9
prothèse de l'articulation de la hanche
implant utilisé pour remplacer l'une des deux ou les deux surfaces articulaires de l'articulation de la
hanche
Note 1 à l'article: Un implant destiné à remplacer uniquement la surface articulaire fémorale de l'articulation de
la hanche est appelé «prothèse partielle de l'articulation de la hanche» (3.12).
Note 2 à l'article: Un implant destiné à remplacer les surfaces fémorale et acétabulaire de l'articulation de la
hanche est appelé «prothèse totale de l'articulation de la hanche» (3.16).
Note 3 à l'article: Le terme «arthroplastie de la hanche» désigne l'acte consistant à implanter une prothèse de
l'articulation de la hanche.
4
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ISO 21535:2023(F)
3.10
composant modulaire
composant fémoral (3.7) ou composant acétabulaire (3.1) composé de deux sous-composants ou plus
Note 1 à l'article: Un composant modulaire peut être fourni préassemblé ou sous forme de composants séparés à
assembler par l'utilisateur.
3.11
composant monobloc
composant constitué d'une seule partie, sans modularité
3.12
prothèse partielle de l'articulation de la hanche
implant comprenant un composant fémoral (3.7) destiné à remplacer uniquement la surface articulaire
fémorale de l'articulation de la hanche
Note 1 à l'article: Une prothèse modulaire partielle de l'articulation de la hanche comprend une tête bipolaire ou
unipolaire.
Note 2 à l'article: Le terme «hémiarthroplastie de la hanche» désigne l'acte consistant à implanter une prothèse
partielle de l'arti
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21535
ISO/TC 150/SC 4
Non-active surgical implants —
Secretariat: BSI
Joint replacement implants —
Voting begins on:
2023-03-08 Specific requirements for hip-joint
replacement implants
Voting terminates on:
2023-05-03
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation de la hanche
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 21535:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 21535:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21535
ISO/TC 150/SC 4
Non-active surgical implants —
Secretariat: BSI
Joint replacement implants —
Voting begins on:
Specific requirements for hip-joint
replacement implants
Voting terminates on:
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation de la hanche
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 21535:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 21535:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Intended performance .7
5 Design attributes .7
5.1 General . 7
5.2 Tolerances and dimensions . 8
5.2.1 Tolerances and dimensions of taper connections . 8
5.2.2 Tolerances on diameters of articulating surfaces, sphericity of articulating
surfaces and surface finish of articulating surfaces . 8
5.3 Thickness of acetabular components, bipolar heads and dual mobility heads . 9
5.3.1 General . 9
5.3.2 Thickness of UHMWPE in acetabular components, bipolar heads and dual
mobility heads . 9
5.3.3 Thickness of metal and ceramic acetabular shell and acetabular liner
components, and bipolar heads and dual mobility heads . 10
6 Materials .11
7 Design evaluation .11
7.1 General . 11
7.2 Preclinical evaluation . .12
7.2.1 General .12
7.2.2 Test methods and performance requirements . 14
7.3 Clinical investigation . 20
7.4 Post market surveillance . 20
8 Manufacture .20
9 Sterilization .20
10 Packaging.21
11 Information to be supplied by the manufacturer .21
11.1 General . 21
11.2 Product type and dimensions . 21
11.3 Structural and functional compatibility of components . 21
11.4 Marking . 21
11.5 Information for the patient . 22
11.6 Information for the surgeon . 22
11.7 Electronic instructions for use .22
Annex A (normative) Evaluation of the range of relative angular motion of the femoral and
acetabular components of a total hip replacement .23
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .25
Bibliography .29
iii
© ISO 2023 – All rights reserved
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ISO/FDIS 21535:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 4, Bone and joint replacements, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 21535:2007), which has been technically
revised. It also incorporates the Amendment ISO 21535:2007/Amd 1:2016.
The main changes are as follows:
— The scope has been expanded to specify more precisely the hip joint replacement types which are
the subject of this document. Also, the scope now clarifies the requirements for implants which have
been legally marketed and for which there is a history of sufficient and safe clinical use.
— The number of normative references has been expanded, including the addition of several ASTM
standards.
— Several new definitions have been added, including: bipolar femoral hip and bipolar femoral hip joint
replacement, bipolar femoral component, constrained hip and constrained hip joint replacement,
dual mobility head and dual mobility femoral component, dual mobility hip and dual mobility hip
joint replacement, femoral head, reference implant, resurfacing hip joint replacement, sufficient and
safe clinical use, ultra-high molecular weight polyethylene and UHMWPE, and worst case.
— The design attributes to be taken into account have been specified in Clause 5. The requirements
for tolerances, dimensions and thickness of various hip components made from plastic, metal and
ceramic have been expanded.
— Several new general requirements have been added in 7.2.1, which specify
a) the circumstances when a test can be omitted,
b) the testing of the worst case,
iv
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ISO/FDIS 21535:2023(E)
c) the processes to be followed when no performance requirement has been specified, and
d) the processes to be followed when a performance requirement has been specified but has not
been met.
— The number of pre-clinical evaluations (bench tests) to be performed has been greatly increased
in 7.2.2. For some of the tests, a performance requirement has been specified. For some of the
tests, no performance requirement has been specified, and, in these cases, a new requirement has
been added, namely the requirement to demonstrate that the performance of the implant under
evaluation is the same or better than that of a reference implant. If no reference implant exists, a
sequence of alternative options has been specified. These alternative options are also available in
the case where there is a performance requirement, which is not met by the implant being tested.
— A new clinical investigation subclause has been added in 7.3, with several requirements which
specify the circumstances in which a clinical investigation can be required.
— A new postmarket surveillance subclause has been added in 7.4, which references the requirements
in ISO 21534:2007, 7.4.
— A warning for the surgeon about the consequences of component malposition or the use of specific
components which can decrease joint range of motion has been added in 11.6.
— A note has been added in 11.7 which states that in some jurisdictions there is the option to provide
the instructions for use in electronic instead of paper format.
— All the figures have been revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
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---------------------- Page: 5 ----------------------
ISO/FDIS 21535:2023(E)
Introduction
There are three levels of standards dealing with nonactive surgical implants.
These are as follows, with level 1 being the highest:
— level 1: general requirements for non-active surgical implants and instrumentation used in
association with implants;
— level 2: particular requirements for families of non-active surgical implants;
— level 3: specific requirements for types of non-active surgical implant.
This document is a level 3 standard and contains requirements applying specifically to hip joint
replacements.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It
also indicates that there are additional requirements in the level 2 and level 3 standards.
The level 2 standards apply to more restricted sets or families of implants such as those designed for
use in osteosynthesis, cardiovascular surgery or joint replacement. For joint replacement implants, the
level 2 standard is ISO 21534.
To address all requirements, it is recommended that a standard of the lowest available level be consulted
first.
vi
© ISO 2023 – All rights reserved
---------------------- Page: 6 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21535:2023(E)
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
1 Scope
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 nonmetallic 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 58341, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 6475, Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface
— Mechanical requirements and test methods
ISO 72061:2008, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and
designation of dimensions
ISO 72062, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces
made of metallic, ceramic and plastics materials
ISO 72064, Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of
endurance properties and performance of stemmed femoral components
ISO 72066, 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 720610, Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of
resistance to static load of modular femoral heads
ISO 720612, Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test
method for acetabular shells
ISO 720613, Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of
resistance to torque of head fixation of stemmed femoral components
1
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ISO/FDIS 21535:2023(E)
ISO 109931, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11491, Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip
joint prostheses
ISO 142421, Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement
parameters for wear-testing machines and corresponding environmental conditions for test
ISO 142422, Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ISO 142423, Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement
parameters for orbital bearing type wear testing machines and corresponding environmental conditions
for test
ISO 142424, Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses
under variations in component positioning which results in direct edge loading
ISO 14630, Non-active surgical implants — General requirements
ISO 21534:2007, Non-active surgical implants — Joint replacement implants — Particular requirements
ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated
Form for Surgical Implants
ASTM F1820, Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular
Devices
ASTM F1875, Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper Interface
ASTM F2009, Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of
Modular Prostheses
ASTM F2033, Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces
Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2345, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads
ASTM F2580, Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip
Prosthesis
ASTM F2582, Standard Test Method for Impingement of Acetabular Prostheses
ASTM F3018, Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip
Resurfacing Arthroplasty Devices
ASTM F3047M, Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
ASTM F3090, Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
ASTM F3143, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Replacement Bearings Under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3446, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Implants Using an Anatomical Motion Hip Simulator
2
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ISO/FDIS 21535:2023(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630, ISO 21534, ISO 7206-1,
ISO 7206-2, ISO 7206-10 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
acetabular component
implant intended to be fixed to the prepared biological acetabulum
Note 1 to entry: The acetabular component can be of monobloc or modular construction. If modular, typically
there can be two sub-components, each fulfilling a different function: one is the bearing surface and the other
provides the means of fixation to the prepared biological acetabulum. The bearing surface is also referred to as
the liner (or the insert) and the other subcomponent is also referred to as the shell or cup.
3.2
bipolar femoral hip
bipolar femoral hip joint replacement
type of partial hip joint replacement (3.12) consisting of a bipolar head (3.3) and a femoral component
(3.7)
3.3
bipolar head
bipolar femoral component
component of a bipolar femoral hip (3.2) with a concave (inner) surface intended to articulate with
the spherical head of the femoral component (3.7) and a convex (outer) spherical surface intended to
articulate with the biological acetabulum
Note 1 to entry: The bipolar head can be a monobloc component (3.11) or a modular component (3.10).
Note 2 to entry: The above definition for bipolar femoral component above is compatible with the definition
included in ISO 7206-1:2008, 3.1, but it includes additional information for clarity.
3.4
constrained hip
constrained hip joint replacement
type of total hip joint replacement (3.16) intended to prevent hip dislocation in more than one anatomic
plane, which consists of a femoral component (3.7) and an acetabular component (3.1), which are
connected across the joint
Note 1 to entry: A dual mobility constrained hip is a type of constrained hip which consists of a femoral component
(3.7), a dual mobility head (3.5), and a modular constrained acetabular component, which are connected across
the joint. This type of constrained hip is also called a “tripolar hip”. Although the term “tripolar” is used to
describe the construct, there are only two bearings.
3.5
dual mobility head
dual mobility femoral component
component of a total hip joint replacement (3.16) with a concave (inner) surface intended to articulate
with the spherical head of the femoral component (3.7) and a convex (outer) spherical surface intended
to articulate with an acetabular component (3.1)
Note 1 to entry: The dual mobility head can be a monobloc component (3.11) or a modular component (3.10).
3
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ISO/FDIS 21535:2023(E)
3.6
dual mobility hip
dual mobility hip joint replacement
type of total hip joint replacement (3.16) consisting of a femoral component (3.7), dual mobility head (3.5)
and an acetabular component (3.1)
3.7
femoral component
part of a total hip joint replacement (3.16) or a partial hip joint replacement (3.12) which is intended to be
fixed to the proximal femur
Note 1 to entry: The femoral component fulfils two different functions: one is to provide the bearing surface and
the other is to provide the means of fixation to the proximal femur.
Note 2 to entry: The femoral component can be monobloc or modular. If modular, typically there are two sub-
components, each fulfilling a different function: one is the modular femoral head (3.8) and the other is the
modular femoral stem. A modular femoral stem can itself be modular, consisting of a single or multicomponent
modular femoral stem and a single or multicomponent modular femoral neck and taper connection(s).
Note 3 to entry: The femoral component of a resurfacing hip joint replacement (3.14) can also be referred to as the
femoral cap.
3.8
femoral head
part of a total hip joint replacement (3.16) or a partial hip joint replacement (3.12) which articulates with:
a) the natural acetabulum or a bipolar head (3.3), in the case of a partial hip joint replacement (3.12),
and
b) the acetabular component (3.1) or a dual mobility head (3.5), in the case of a total hip joint replacement
(3.16)
3.9
hip joint replacement
implant used to replace one or both of the articulating surfaces of the hip joint
Note 1 to entry: An implant intended to replace only the femoral articulating surface of the hip joint is referred to
as partial hip joint replacement (3.12).
Note 2 to entry: An implant intended to replace the femoral and acetabular surfaces of the hip joint is referred to
as total hip joint replacement (3.16).
Note 3 to entry: The term hip arthroplasty refers to the act of implanting a hip joint replacement.
3.10
modular component
femoral component (3.7) or acetabular component (3.1) that consists of two or more subcomponents
Note 1 to entry: A modular component can be supplied preassembled or as separate components to be assembled
by the user.
3.11
monobloc component
component that consists of a single part with no modularity
3.12
partial hip joint replacement
implant comprising a femoral component (3.7) intended to replace only the femoral articulating surface
of the hip joint
Note 1 to entry: A modular partial hip joint replacement incorporates either a bipolar or a unipolar head.
Note 2 to entry: The term hip hemiarthroplasty refers to the act of implanting a partial hip joint replacement.
4
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ISO/FDIS 21535:2023(E)
Note 3 to entry: A partial hip joint replacement is sometimes referred to as a “hemi”.
3.13
reference implant
legally-marketed implant which, when compared to the implant under evaluation, satisfies both of the
following conditions:
a) it has the same intended use, similar materials and a similar design with regard to the specific
dimensional or performance criteria under evaluation to address the same clinical and technical
requirements, and
b) there is evidence of successful clinical use in sufficient numbers; for a sufficient period of time; and
at a minimum, without known or reasonably-known evidence of design or performance-related
recalls with regard to the specific dimensional or performance criteria under evaluation
Note 1 to entry: The term “reference” is not
...
ISO/FDIS 21535
ISO/TC 150/SC 4
Secretariat: BSI
Date: 2023-02-22
Non-active surgical implants — Joint replacement implants —
Specific requirements for hip-joint replacement implants
Implants chirurgicaux non actifs — Implants de remplacement d'articulation — Exigences spécifiques
relatives aux implants de remplacement de l'articulation de la hanche
FDIS stage
© ISO 2023 – All rights reserved
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ISO/FDIS 21535:20212023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 20212023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DISFDIS 21535:20212023(E)
Contents Page
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 7
5 Design attributes . 7
5.1 General . 7
5.2 Tolerances and dimensions . 8
5.2.1 Tolerances and dimensions of taper connections . 8
5.2.2 Tolerances on diameters of articulating surfaces, sphericity of articulating surfaces and surface
finish of articulating surfaces . 8
5.3 Thickness of acetabular components, bipolar heads and dual mobility heads . 9
5.3.1 General . 9
5.3.2 Thickness of UHMWPE in acetabular components, bipolar heads and dual mobility heads . 9
5.3.3 Thickness of metal and ceramic acetabular shell and acetabular liner components, and bipolar
heads and dual mobility heads . 10
6 Materials . 11
7 Design evaluation . 11
7.1 General . 11
7.2 Pre-clinical evaluation . 12
7.2.1 General . 12
7.2.2 Test methods and performance requirements . 13
7.3 Clinical investigation . 19
7.4 Post market surveillance . 20
8 Manufacture . 20
9 Sterilization . 20
10 Packaging . 20
11 Information to be supplied by the manufacturer . 20
11.1 General . 20
11.2 Product type and dimensions . 20
11.3 Structural and functional compatibility of components . 20
11.4 Marking . 21
11.5 Information for the patient . 21
11.6 Information for the surgeon . 21
11.7 Electronic instructions for use . 21
Annex A (normative) Evaluation of the range of relative angular motion of the femoral and acetabular
components of a total hip replacement . 22
Annex ZA (informative) Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 25
Bibliography . 29
iii
© ISO 2023 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 21535:20212023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 4, Bone and joint replacements, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 21535:2007), which has been technically
revised. It also incorporates the Amendment ISO 21535:2007/Amd 1:2016.
This third edition is a major revision with many added requirements. The main changes are as follows:
— 1 Scope
— The scope ishas been expanded to specify more precisely the hip joint replacement types which are
the subject of this document. Also, the scope now clarifies the requirements for implants which have
been legally marketed and for which there is a history of sufficient and safe clinical use.
— 2 Normative references
— The number of normative references has been expanded, including the addition of several ASTM
standards.
— 3 Terms and definitions
— Several new definitions arehave been added, including: a) bipolar femoral hip, b) and bipolar femoral
hip joint replacement, bipolar femoral component, constrained hip, c) and constrained hip joint
replacement, dual mobility head, d) and dual mobility hip, e)femoral component, dual mobility hip
and dual mobility hip joint replacement, femoral head, f) reference implant, g) resurfacing hip joint
replacement, h) sufficient and safe clinical use, i) ultra-high molecular weight polyethylene and
UHMWPE, and j) worst case.
iv © ISO 20212023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DISFDIS 21535:20212023(E)
— 5 Design attributes
The design attributes to be taken into account arehave been specified in Clause 5.
— . The requirements for a) tolerances, b) dimensions and c) thickness of various hip components made
from plastic, metal and ceramic have been expanded.
— 7.2.1 General
— Several new general requirements arehave been added in 7.2.1. These new requirements a), which
specify
a) the circumstances when a test can be omitted, b) specify that
b) the testing of the worst case shall be tested, c) specify ,
a)c) the processes to be followed when no performance requirement has been specified, and
b)d) d) specify the processes to be followed when a performance requirement has been
specified but has not been met.
— 7.2.2 Pre-clinical evaluation
— The number of pre-clinical evaluations (bench tests) to be performed ishas been greatly increased in
7.2.2. For some of the tests, a performance requirement ishas been specified. For some of the tests,
no performance requirement ishas been specified, and, in these cases, a new requirement has been
added, namely the requirement to demonstrate that the performance of the implant under evaluation
is the same or better than that of a reference implant. If no reference implant exists, a sequence of
alternative options ishas been specified. These alternative options are also available in the case where
there is a performance requirement, which is not met by the implant being tested.
— 7.3 Clinical investigation
— A new clinical investigation subclause ishas been added in 7.3, with several requirements which
specify the circumstances in which a clinical investigation can be required.
— 7.4 Post market surveillance
— A new post-market surveillance subclause ishas been added in 7.4,, which references the
requirements in ISO 21534:2007, 7.4.
— 11.6 Information for the surgeon
— A warning for the surgeon about the consequences of component malposition or the use of specific
components which can decrease joint range of motion ishas been added in 11.6.
— 11.7 Electronic instructions for use
— A note ishas been added in 11.7 which states that in some jurisdictions there is the option to provide
the instructions for use in electronic instead of paper format.
— Annex A
— All the figures werehave been revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
Field Code Changed
v
© ISO 2023 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/FDIS 21535:20212023(E)
Introduction
There are three levels of standards dealing with non-active surgical implants.
These are as follows, with level 1 being the highest:
— — level 1: general requirements for non-active surgical implants and instrumentation used in
association with implants;
— — level 2: particular requirements for families of non-active surgical implants;
— — level 3: specific requirements for types of non-active surgical implant.
This document is a level 3 standard and contains requirements applying specifically to hip joint
replacements.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It
also indicates that there are additional requirements in the level 2 and level 3 standards.
The level 2 standards apply to more restricted sets or families of implants such as those designed for use
in osteosynthesis, cardiovascular surgery or joint replacement. For joint replacement implants, the level
2 standard is ISO 21534.
To address all requirements, it is recommended that a standard of the lowest available level be consulted
first.
vi © ISO 20212023 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/FDIS 21535:2023(E)
Non-active surgical implants — Joint replacement implants —
Specific requirements for hip-joint replacement implants
1 Scope
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 7.2.1.27.2.1.2.
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5834-1, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 6475, Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface
— Mechanical requirements and test methods
ISO 7206--1:2008, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification
and designation of dimensions
ISO 7206--2, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces
made of metallic, ceramic and plastics materials
ISO 7206--4, Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of
endurance properties and performance of stemmed femoral components
ISO 7206--6, 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, Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of
resistance to static load of modular femoral heads
ISO 7206--12, Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test
method for acetabular shells
ISO 7206--13, Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of
resistance to torque of head fixation of stemmed femoral components
ISO 10993-1, Biological evaluation of medical devices –— Part 1: Evaluation and testing within a risk
management process
ISO 11491, Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip
joint prostheses
© ISO 2023 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO/FDIS 21535:2023(E)
ISO 14242--1, Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and
displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242--2, Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ISO 14242--3, Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and
displacement parameters for orbital bearing type wear testing machines and corresponding environmental
conditions for test
ISO 14242--4, Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses
under variations in component positioning which results in direct edge loading
ISO 14630, Non-active surgical implants — General requirements
ISO 21534:2007, Non-active surgical implants — Joint replacement implants — Particular requirements
ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated
Form for Surgical Implants
ASTM F1820, Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular
Devices
ASTM F1875, Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper Interface
ASTM F2009, Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of
Modular Prostheses
ASTM F2033, Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces
Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2345, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads
ASTM F2580, Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip
Prosthesis
ASTM F2582, Standard Test Method for Impingement of Acetabular Prostheses
ASTM F3018, Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip
Resurfacing Arthroplasty Devices
ASTM F3047M, Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard
Articulations
ASTM F3090, Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
ASTM F3143, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Replacement Bearings Under Standard Conditions Using a Reciprocal Friction Simulator
ASTM F3446, Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip
Implants Using an Anatomical Motion Hip Simulator
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630, ISO 21534, ISO 7206-1,
ISO 7206-2, ISO 7206-10 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
2 © ISO 2023 – All rights reserved
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ISO/FDIS 21535:2023(E)
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
3.1
acetabular component
implant intended to be fixed to the prepared biological acetabulum
Note 1 to entry: The acetabular component can be of monobloc or modular construction. If modular, typically there
can be two sub-components, each fulfilling a different function: one is the bearing surface and the other provides
the means of fixation to the prepared biological acetabulum. The bearing surface is also referred to as the liner (or
the insert) and the other sub-component is also referred to as the shell or cup.
3.2
bipolar femoral hip
bipolar femoral hip joint replacement
type of partial hip joint replacement (3.12(3.12)) consisting of a bipolar head (3.3(3.3)) and a femoral
component (3.7(3.7))
3.3
bipolar head
bipolar femoral component
component of a bipolar femoral hip (3.2(3.2)) with a concave (inner) surface intended to articulate with
the spherical head of the femoral component (3.7(3.7)) and a convex (outer) spherical surface intended
to articulate with the biological acetabulum
Note 1 to entry: The bipolar head can be a monobloc component (3.11(3.11)) or a modular component (3.10(3.10).).
Note 2 to entry: The above definition for bipolar femoral component above is compatible with the definition
included in ISO 7206-1:2008, 3.1, but it includes additional information for clarity.
3.4
constrained hip
constrained hip joint replacement
type of total hip joint replacement (3.16(3.16)) intended to prevent hip dislocation in more than one
anatomic plane, which consists of a femoral component (3.7(3.7)) and an acetabular component
(3.1(3.1),), which are connected across the joint
Note 1 to entry: A dual mobility constrained hip is a type of constrained hip which consists of a femoral component
(3.7(3.7),), a dual mobility head (3.5(3.5),), and a modular constrained acetabular component (3.1),, which are
connected across the joint. This type of constrained hip is also called a “tripolar hip”. Although the term “tripolar” is
used to describe the construct, there are only two bearings.
3.5
dual mobility head
dual mobility femoral component
component of a total hip joint replacement (3.16(3.16)) with a concave (inner) surface intended to
articulate with the spherical head of the femoral component (3.7(3.7)) and a convex (outer) spherical
surface intended to articulate with an acetabular component (3.1(3.1))
Note 1 to entry: The dual mobility head can be a monobloc component (3.11(3.11)) or a modular component
(3.10(3.10).).
3.6
dual mobility hip
dual mobility hip joint replacement
type of total hip joint replacement (3.16(3.16)) consisting of a femoral component (3.7(3.7),), dual mobility
head (3.5(3.5)) and an acetabular component (3.1(3.1))
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ISO/FDIS 21535:2023(E)
3.7
femoral component
part of a total hip joint replacement (3.16(3.16)) or a partial hip joint replacement (3.12(3.12)) which is
intended to be fixed to the proximal femur
Note 1 to entry: The femoral component fulfils two different functions: one is to provide the bearing surface and the
other is to provide the means of fixation to the proximal femur.
Note 2 to entry: The femoral component can be monobloc or modular. If modular, typically there are two sub-
components, each fulfilling a different function: one is the modular femoral head (3.8(3.8)) and the other is the
modular femoral stem.
Note 3 to entry: A modular femoral stem (see Note 2 to entry) can itself be modular, consisting of a single or multi-
component modular femoral stem and a single or multi-component modular femoral neck and taper connection(s).
Note 4 3 to entry: The femoral component of a resurfacing hip joint replacement (3.14(3.14)) can also be referred
to as the femoral cap.
3.8
femoral head
part of a total hip joint replacement (3.16(3.16)) or a partial hip joint replacement (3.12(3.12)) which
articulates with:
a) a) the natural acetabulum or a bipolar head (3.3(3.3),), in the case of a partial hip joint replacement
(3.12(3.12);), and
b) b) the acetabular component (3.1(3.1)) or a dual mobility head (3.5(3.5),), in the case of a total hip
joint replacement (3.16(3.16))
3.9
hip joint replacement
implant used to replace one or both of the articulating surfaces of the hip joint
Note 1 to entry: An implant intended to replace only the femoral articulating surface of the hip joint is referred to
as partial hip joint replacement (3.12(3.12).).
Note 2 to entry: An implant intended to replace the femoral and acetabular surfaces of the hip joint is referred to as
total hip joint replacement (3.16(3.16).).
Note 3 to entry: The term hip arthroplasty refers to the act of implanting a hip joint replacement.
3.10
modular component
femoral component (3.7(3.7)) or acetabular component (3.1(3.1)) that consists of two or more sub-
components
Note 1 to entry: A modular component can be supplied preassembled or as separate components to be assembled
by the user.
3.11
monobloc component
component that consists of a single part with no modularity
3.12
partial hip joint replacement
implant comprising a femoral component (3.7(3.7)) intended to replace only the femoral articulating
surface of the hip joint
Note 1 to entry: A modular partial hip joint replacement incorporates either a bipolar or a unipolar head.
Note 2 to entry: The term hip hemiarthroplasty refers to the act of implanting a partial hip joint replacement.
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ISO/FDIS 21535:2023(E)
Note 3 to entry: A partial hip joint replacement is sometimes referred to as a “hemi”.
3.13
reference implant
legally-marketed implant which, when compared to the implant under evaluation, satisfies both of the
following conditions:
a) a) it has the same intended use, similar materials and a similar design with regard to the specific
dimensional or performance criteria under evaluation to address the same clinical and technical
requirements, and
b) b) there is evidence of successful clinical use in sufficient numbers; for a sufficient period of time;
and at a minimum, without known or reasonably-known evidence of design or performance-related
recalls with regard to the specific dimensional or performance criteria under evaluation
Note 1 to entry: The term “reference” is not intended to imply that the implant under evaluation and the reference
implant are “equivalent” or that the reference implant is a “predicate” implant. This is because for some regulatory
authorities, the terms “equivalent” and “predicate” have a meaning, which is beyond that intended by the term
“reference” as used in this document.
Note 2 to entry: A reference implant is the comparison implant for dimensional or performance parameter(s) under
evaluation. Other characteristics of the reference implant shall be considered in order for the comparison to be
suitable, as in some situations there can be cross-effects. Ideally, for the majority of dimensional and performance
parameters, a single reference implant should be used for comparison to the implant under evaluation. However,
more than one reference implant may be used for comparison purposes, with adequate scientific and clinical
justification.
Note 3 to entry: Some regulatory authorities require that a reference implant is one that is legally marketed in their
own country or jurisdiction. This fact can be taken into account when selecting a reference implant for the purposes
of this document.
Note 4 to entry: There is no agreed upon interpretation for what constitutes “sufficient numbers” or a “sufficient
period of time” in the above definition. T
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