kSIST FprEN ISO 21535:2023
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023)
This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.
This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials.
This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2.
The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle Anforderungen an Implantate für den Hüftgelenkersatz (ISO/FDIS 21535:2023)
Dieses Dokument legt Anforderungen an Implantate für den Hüftgelenkersatz fest. Im Hinblick auf Sicherheit legt dieses Dokument Anforderungen an die vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, die Bereitstellung von Informationen durch den Hersteller und Prüfverfahren fest.
Dieses Dokument gilt für Implantate sowohl zum totalen als auch zum partiellen Hüftgelenkersatz. Es gilt für Komponenten aus metallischen und nichtmetallischen Werkstoffen.
Dieses Dokument gilt für eine Vielzahl von Hüftgelenkersatzimplantaten. Auf einige spezifische Typen von Hüftgelenkersatzimplantaten können jedoch bestimmte Überlegungen zutreffen, die in diesem Dokument nicht spezifisch abgedeckt sind. Weitere Einzelheiten sind in 7.2.1.2 angegeben.
Hinter den in diesem Dokument festgelegten Anforderungen steht nicht die Absicht, eine Neukonstruktion oder erneute Prüfung von Implantaten zu verlangen, die rechtmäßig in Verkehr gebracht wurden und die über eine Vorgeschichte der ausreichenden und sicheren klinischen Anwendung verfügen. Die Übereinstimmung solcher Implantate mit diesem Dokument kann durch den Nachweis der ausreichenden und sicheren klinischen Anwendung des Implantats belegt werden.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO/FDIS 21535:2023)
Le présent document spécifie les exigences relatives aux prothèses de l'articulation de la hanche. En matière de sécurité, le présent document fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant ainsi que des méthodes d'essai.
Le présent document s'applique à la fois aux implants de remplacement total et partiel de l'articulation de la hanche. Il s'applique aux composants fabriqués en matériaux métalliques et non métalliques.
Le présent document s'applique à une grande variété d'implants, mais certaines considérations, non spécifiquement couvertes dans le présent document, peuvent être applicables à certains types spécifiques d'implants de remplacement de l'articulation de la hanche. Voir 7.2.1.2 pour plus de détails.
Les exigences spécifiées dans le présent document n'ont pas pour but d'exiger une nouvelle conception ou de nouveaux essais sur des implants qui ont été légalement mis sur le marché et pour lesquels il existe un historique d'utilisation clinique suffisante et sans danger. Pour ces implants, la conformité au présent document peut être démontrée en fournissant la preuve d'une utilisation clinique suffisante et sans danger de l'implant.
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO/FDIS 21535:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 21535:2021
01-oktober-2021
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO/DIS 21535:2021)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO/DIS 21535:2021)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz (ISO/DIS 21535:2021)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche
(ISO/DIS 21535:2021)
Ta slovenski standard je istoveten z: prEN ISO 21535
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 21535:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 21535:2021
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oSIST prEN ISO 21535:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21535
ISO/TC 150/SC 4 Secretariat: BSI
Voting begins on: Voting terminates on:
2021-07-22 2021-10-14
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 21535:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 6
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 . 8
5.3.1 General. 8
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 . 9
6 Materials .10
7 Design evaluation .10
7.1 General .10
7.2 Pre-clinical evaluation .10
7.2.1 General.10
7.2.2 Test methods and performance requirements .12
7.3 Clinical investigation .19
8 Manufacture .19
9 Sterilization .19
10 Packaging .19
11 Information to be supplied by the manufacturer .19
11.1 General .19
11.2 Product type and dimensions .20
11.3 Structural and functional compatibility of components .20
11.4 Marking .20
11.5 Information for the patient .20
11.6 Information for the surgeon .21
11.7 Electronic instructions for use .21
Annex A (informative) Evaluation of 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 .28
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oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part
2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 21535 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.
This third edition cancels and replaces the second edition (ISO 21535:2007), which has been technically
revised.
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oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(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 standard 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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oSIST prEN ISO 21535:2021
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oSIST prEN ISO 21535:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 21535:2021(E)
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
1 Scope
This document provides specific 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, may be
applicable. Further details are given in Clause 7.2.1.1.
The requirements which are specified in this document are not intended to require the re-design or
re-testing of devices which have been legally marketed and for which there is a history of sufficient and
safe clinical use. For such devices compliance with this document shall be demonstrated by providing
evidence of the sufficient and safe clinical use.
2 Normative references
The following referenced documents are indispensable for the application 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 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 11491, Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip
joint prostheses
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ISO/DIS 21535:2021(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 17853, Wear of implant materials — Polymer and metal wear particles — Isolation and characterization
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 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 F1877, Standard Practice for Characterization of Particles
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 in ISO 21534, ISO 7206-1, ISO 7206-2 and
ISO 7206-10 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available from https:// www .iso .org/ obp
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— IEC Electropedia: available from 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 sometimes referred to as the shell.
3.2
bipolar femoral hip
type of partial hip joint replacement consisting of a bipolar femoral component and a femoral component
3.3
bipolar head
bipolar femoral component
component of a partial hip joint replacement with a concave (inner) surface intended to articulate
with the spherical head of the femoral component 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 or a modular component.
3.4
constrained hip
type of total hip joint replacement intended to prevent hip dislocation in more than one anatomic plane,
which consists of femoral and acetabular components, 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 with a concave (inner) surface intended to articulate with the
spherical head of the femoral component and a convex (outer) spherical surface intended to articulate
with an acetabular component
Note 1 to entry: The dual mobility head can be a monobloc component or a modular component.
3.6
dual mobility hip
type of total hip joint replacement 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 or partial hip joint replacement which is intended to be fixed to the proximal femur
Note 1 to entry: The femoral component fulfills 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 2 sub-
components, each fulfilling a different function: one is the modular femoral head (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).
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ISO/DIS 21535:2021(E)
Note 4 to entry: The femoral component of a resurfacing hip joint replacement can also be referred to as the
femoral cap.
3.8
femoral head
the part of a total or partial hip joint replacement which articulates with:
a) the natural acetabulum or a bipolar head (3.3), in the case of a partial hip joint replacement (3.12);
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 (see 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 (see 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 or acetabular component 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
Note 1 to entry: Derived from ISO 7206-1:2008, 3.6
3.12
partial hip joint replacement
implant comprising a femoral component (3.7) intended to replace the femoral articulating surface of
the hip joint
Note 1 to entry: Modular partial hip joint replacement implants incorporate 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.
Note 3 to entry: A partial hip joint replacement is sometimes referred to as a “hemi”.
3.13
reference device
a legally-marketed device which, when compared to the device under investigation, satisfies both of the
following conditions:
1) 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
2) there is evidence of clinical use in sufficient numbers; for a sufficient period of time; and, at a
minimum, without known or reasonably-known evidence of device-related recalls with regard to
the specific dimensional or performance criteria under evaluation.
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ISO/DIS 21535:2021(E)
Note 1 to entry: The term “reference” is not intended to imply that the device under investigation and the
reference device are “equivalent” or that the reference device is a “predicate” device. This is because in some
regulatory regimes 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: For the purposes of this document, a reference device is the comparison device for the performance
parameter under consideration. For each performance parameter there can be a different reference device. The
reference device can be different from the device under investigation with respect to other parameters.
Note 3 to entry: Some regulatory regimes require that a legally-marketed device is one that is legally marketed in
their own country or jurisdiction. This fact may need to be taken into account when selecting a reference device
for the purposes of this document.
Note 4 to entry: There is no agreed interpretation for what constitutes “sufficient numbers” or a “sufficient
period of time” in the above definition. ISO 21534:2007, Clause 6.1, Note 3 gives an example of what may be a
sufficient number of implants and a sufficient number of years of evidence. The example in ISO 21534: 2007,
Clause 6.1 is not included here as a requirement, only as an example which may be useful when interpreting what
may be “sufficient clinical evidence”. 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 device performance.
Note 5 to entry: A justification for a “similar material” might include information that although the materials
are not the same, the material(s) used for the device under investigation can be shown to perform similarly with
regard to the test or its underlying clinical concern.
Note 6 to entry: Examples of design features that may be taken into consideration when evaluating whether a
device has ‘similar design’ to the device under investigation include means of fixation, modularity, constraint,
key dimensions, processing, surface treatment, etc. A justification for a “similar design” therefore might include
information that although the designs are not the same, the design of the device under investigation can be
shown to perform similarly with regard to the test or its underlying clinical concern.
Note 7 to entry: Identification of a reference device is at the discretion of the manufacturer and regulatory body
in accordance with the regulatory requirements in the jurisdictions where the device is marketed.
3.14
resurfacing hip joint replacement
type of total or partial hip joint replacement intended to replace (1) only the femoral articulating surface
of the joint in a partial hip replacement, which usually consists of a monobloc femoral cap component,
with a central stem, that is placed over the head of a prepared biological femoral head and intended to
articulate with the biological acetabulum; or (2) both the femoral and acetabular articulating surfaces
of the joint in a total hip replacement, which consists of a monobloc femoral cap component; and a
matching monobloc or modular acetabular component (3.1)
3.15
sufficient and safe clinical use
Clinical use of a legally-marketed device a) in sufficient numbers, b) for a sufficient period of time and c)
at a minimum, without known or reasonably-known evidence of device-related recalls.
Note 1 to entry: There is no agreed interpretation for what constitutes “sufficient numbers” or “sufficient period
of time” in the above definition. Typically, these are demonstrated by using statistical methods and clinical
judgement in the evaluation of device performance.
Note 2 to entry: Some regulatory regimes require that a legally-marketed device is one which is legally marketed
in their country or jurisdiction.
Note 3 to entry: For a legally-marketed system of hip replacement implants there may be evidence to demonstrate
sufficient and safe clinical use for some parts of the system (e.g. some components and some sizes) but not for
others. For those parts of the system for which there is sufficient evidence the requirements of this document
relating to design and testing shall not apply.
Note 4 to entry: This document does apply to those parts o
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