EN ISO 21535:2024

SLOVENSKI STANDARD
01-september-2024
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO 21535:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO 21535:2023)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle
Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2023)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO
21535:2023)
Ta slovenski standard je istoveten z: EN ISO 21535:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21535
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 21535:2009, EN ISO
21535:2009/A1:2016
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants
(ISO 21535:2023)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Spezielle Anforderungen an Implantate
relatives aux implants de remplacement de für den Hüftgelenkersatz (ISO 21535:2023)
l'articulation de la hanche (ISO 21535:2023)
This European Standard was approved by CEN on 4 June 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21535:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4

European foreword
This document (EN ISO 21535:2024) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2025, and conflicting national standards shall
be withdrawn at the latest by January 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21535:2009, EN ISO 21535:2009/A1:2016.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21535:2023 has been approved by CEN as EN ISO 21535:2024 without any modification.

Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European Standard has been prepared under a Commission’s standardization request “M/575” to
provide one voluntary means of conforming to the General Safety and Performance Requirements of
Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
For application of this European standard under Regulation (EU) 2017/745,
1. it is clarified that the third paragraph of the scope and the related subclause 7.2.1.2 are solely
intended to point out that additional testing not specified in this document can be required to
ensure the safety and efficacy of implants for which failure modes exist which were unknown at
the time of drafting of this document;
2. it is clarified that the fourth paragraph of the scope and related language in the first paragraphs
of Clauses 4, 5, 6 and 7 are intended to avoid unnecessary re-design or re-testing of implants
which are currently legally marketed in the European Union;
3. it is recognized that the normatively referenced ISO 7206-2:2011+Amd 1:2016 itself includes a
reference to the withdrawn ISO 4288:1996 which has been replaced by ISO 21920-3:2021 and
for application of this European standard under Regulation (EU) 2017/745 ISO 21920-3:2021
shall be used instead of ISO 4288:1996;
4. it is recognized that the normatively referenced ISO 10993-1 includes a dated reference to ISO
14971:2007 which is outdated and for application of this European standard under Regulation
(EU) 2017/745 the most recent European version EN ISO 14971:2019 + A11:2021 shall be
used;
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to
be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far
as possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical investigations,
clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements
Remarks / Notes
of Regulation (EU)
of this EN
2017/745
10.1 (c) 10.1 (c) is covered as follows:
5.2.1 The compatibility of taper
connections is covered by 5.2.1.
7.2.2.3
The pull-off and lever off
characteristics of the heads are
covered by 7.2.2.3.
4 and 7.2.2.5 The range of motion is covered
by Clause 4 and 7.2.2.5.
7.2.2.6 The resistance to torque is
covered by 7.2.2.6.
7.2.2.10 The disassembly force is covered
by 7.2.2.10.
7.2.2.11 The fretting corrosion is covered
by 7.2.2.11.
7.2.2.12 Impingement is covered by
7.2.2.12.
7.2.2.13 and 7.2.2.14 The static and fatigue strength of
modular connections is covered
by 7.2.2.13 and 7.2.2.14.
7.2.2.15 The frictional torque of a hip
joint bearing is covered by
7.2.2.15.
10.1 (f) 7.2.2 (all subclauses) 10.1 (f) is covered with the
exception of “ductility” by 7.2.2
(all subclauses).
10.1 (g) 5.2.2 10.1 (g) is covered by 5.2.2.
st
10.4.1 1 paragraph 7.2.2.4 10.4.1 is covered with respect to
wear of the bearings of hip
implants by 7.2.2.4 which
requires that the bearings of hip
joints shall undergo wear testing
and the wear shall be the same or
less than the wear of a reference
implant.
23.4 (s) 11.5 23.4 (s) is covered with respect
to the information for the patient
by 11.5.
11.6 23.4 (s) is covered with respect
to the information for the
surgeon by 11.6.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard Edition
European Standard
Edition
ISO 5834-1 ISO 5834-1:2019 Implants for surgery — Ultra- -
high-molecular-weight
polyethylene — Part 1:
Powder form
ISO 6475 ISO 6475:1989 Implants for surgery — Metal -
bone screws with
asymmetrical thread and
spherical under-surface —
Mechanical requirements and
test methods
ISO 7206-1:2008 ISO 7206-1:2008 Implants for surgery — -
Partial and total hip joint
prostheses — Part 1:
Classification and designation
of dimensions
ISO 7206-2 ISO 7206-2:2011 Implants for surgery — -
and ISO 7206- Partial and total hip joint
2:2011/Amd prostheses — Part 2:
1:2016 Articulating surfaces made of
metallic, ceramic and plastics
materials
ISO 7206-4 ISO 7206-4:2010 Implants for surgery — -
and ISO 7206- Partial and total hip joint
4:2010/Amd prostheses — Part 4:
1:2016 Determination of endurance
properties and performance
of stemmed femoral
components
ISO 7206-6 ISO 7206-6:2013 Implants for surgery — -
Partial and total hip joint
prostheses — Part 6:
Endurance properties testing
and performance
requirements of neck region
of stemmed femoral
components
ISO 7206-10 ISO 7206- Implants for surgery — -
10:2018 and ISO Partial and total hip-joint
7206- prostheses — Part 10:
10:2018/Amd Determination of resistance
1:2021 to static load of modular
femoral heads
ISO 7206-12 ISO 7206- Implants for surgery — -
12:2016 Partial and total hip joint
prostheses — Part 12:
Deformation test method for
acetabular shells
ISO 7206-13 ISO 7206- Implants for surgery — -
13:2016 and ISO Partial and total hip joint
7206- prostheses — Part 13:
13:2016/Amd Determination of resistance
1:2022 to torque of head fixation of
stemmed femoral
components
ISO 10993-1 ISO 10993- Biological evaluation of EN ISO 10993-1:2020
1:2018 medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 11491 ISO 11491:2017 Implants for surgery — -
Determination of impact
resistance of ceramic femoral
heads for hip joint prostheses
ISO 14242-1 ISO 14242- Implants for surgery — Wear -
1:2014 and ISO of total hip-joint prostheses
14242- — Part 1: Loading and
1:2014/Amd displacement parameters for
1:2018 wear-testing machines and
corresponding environmental
conditions for test
ISO 14242-2 ISO 14242- Implants for surgery — Wear -
2:2016 of total hip-joint prostheses
— Part 2: Methods of
measurement
ISO 14242-3 ISO 14242- Implants for surgery — Wear -
3:2009 and ISO of total hip-joint prostheses
14242- — Part 3: Loading and
3:2009/Amd displacement parameters for
1:2019 orbital bearing type wear
testing machines and
corresponding environmental
conditions for test
ISO 14242-4 ISO 14242- Implants for surgery — Wear -
4:2018 of total hip-joint prostheses
— Part 4: Testing hip
prostheses under variations
in component positioning
which results in direct edge
loading
ISO 14630 ISO 14630:2012 Non-active surgical implants EN ISO 14630:2012
— General requirements
ISO 21534:2007 ISO 21534:2007 Non-active surgical implants EN ISO 21534:2009
— Joint replacement implants
— Particular requirements
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in  Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
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 21535:2023(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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
iii
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
iv
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.
v
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.
vi
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
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
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).
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.
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
...