kSIST FprEN ISO 21536:2023
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)
This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.
This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials.
This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2.
The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Spezielle Anforderungen an Implantate für den Kniegelenkersatz (ISO/FDIS 21536:2023)
Dieses Dokument legt besondere Anforderungen an Implantate für den Kniegelenksersatz fest. Unter Berück-sichtigung der Sicherheit legt dieses Dokument Anforderungen an vorgesehene Funktion, Konstruktions-merkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisierung, Verpackung, Bereitstellung von Informa-tionen durch den Hersteller und für Prüfverfahren fest.
Dieses Dokument gilt sowohl für totale als auch für partielle Kniegelenkersatzimplantate. Es gilt für diese Prothesen sowohl mit als auch ohne Ersatz des patellafemoralen Gelenks. Es gilt für Komponenten aus metallischen und nichtmetallischen Werkstoffen.
Dieses Dokument gilt für eine Vielzahl von Kniegelenkersatzimplantaten. Auf einige spezifische Typen von Kniegelenkersatzimplantaten können jedoch bestimmte Überlegungen zutreffen, die in diesem Dokument nicht spezifisch abgedeckt sind. Weitere Einzelheiten sind in 7.2.1.1 angegeben.
Hinter den in diesem Dokument festgelegten Anforderungen steht nicht die Absicht, eine Neukonstruktion oder erneute Prüfung von Produkten zu verlangen, die rechtmäßig in Verkehr gebracht wurden und die über eine Vorgeschichte der ausreichenden und sicheren klinischen Anwendung verfügen. Die Übereinstimmung solcher Produkte mit diesem Dokument muss durch den Nachweis ihrer ausreichenden und sicheren klini-schen Anwendung belegt werden.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO/FDIS 21536:2023)
Le présent document spécifie les exigences relatives aux prothèses de l'articulation du genou. En matière de sécurité, le présent document fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant ainsi que des méthodes d'essai.
Le présent document s'applique à la fois aux implants de remplacement total et partiel de l'articulation du genou. Il s'applique à ces remplacements avec et sans remplacement de l'articulation fémoro-patellaire. Il s'applique aux composants fabriqués en matériaux métalliques et non métalliques.
Le présent document s'applique à une grande variété d'implants, mais certaines considérations, non spécifiquement couvertes dans le présent document, peuvent être applicables à certains types spécifiques d'implants de remplacement de l'articulation du genou. Voir 7.2.1.2 pour plus de détails.
Les exigences spécifiées dans le présent document n'ont pas pour but d'exiger une nouvelle conception ou de nouveaux essais sur des implants qui ont été légalement mis sur le marché et pour lesquels il existe un historique d'utilisation clinique suffisante et sans danger. Pour ces implants, la conformité au présent document peut être démontrée en fournissant la preuve d'une utilisation clinique suffisante et sans danger de l'implant.
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za kolenske proteze (ISO/FDIS 21536:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 21536:2021
01-oktober-2021
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
kolenske proteze (ISO/DIS 21536:2021)
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee-joint replacement implants (ISO/DIS 21536:2021)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz (ISO/DIS 21536:2021)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation du genou (ISO/DIS
21536:2021)
Ta slovenski standard je istoveten z: prEN ISO 21536
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 21536:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 21536:2021
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oSIST prEN ISO 21536:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21536
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 knee-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 21536:2021(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 21536:2021
ISO/DIS 21536:2021(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
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ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 21536:2021
ISO/DIS 21536:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 5
5 Design attributes . 6
5.1 General . 6
5.2 Thickness of knee joint components. 6
5.2.1 General. 6
5.2.2 Thickness of UHMWPE in tibial inserts, monobloc tibial components,
mobile-bearing components, patella inserts and monobloc patellar components 7
5.2.3 Thickness of metal and ceramic in femoral components, tibial trays,
mobile-bearing components and patellar trays . 7
5.3 Surface finish of non-articulating regions of knee joint components. 7
5.4 Surface finish of articulating surfaces of knee joint components . 7
6 Materials . 7
7 Design evaluation . 8
7.1 General . 8
7.2 Pre-clinical evaluation . 8
7.2.1 General. 8
7.2.2 Test methods and performance requirements .10
7.3 Clinical investigation .15
8 Manufacture .16
9 Sterilization .16
10 Packaging .16
11 Information to be supplied by the manufacturer .16
11.1 General .16
11.2 Product type and dimensions .16
11.3 Constructional and functional compatibility of components .17
11.4 Marking .17
11.5 Information for the patient .17
11.6 Electronic instructions for use .17
Annex A (informative) Evaluation of range of relative angular motion of components of
fully constrained total knee joint replacement implants.18
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .19
Bibliography .22
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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 21536 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 21536:2007), which has been technically
revised.
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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 knee 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 21536:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 21536:2021(E)
Non-active surgical implants — Joint replacement implants
— Specific requirements for knee-joint replacement
implants
1 Scope
This document provides specific requirements for knee 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 knee joint replacement implants. It applies to these
replacements both with and without the replacement of the patella-femoral joint. It applies to
components made of metallic and non-metallic materials.
This document applies to a wide variety of knee replacement implants, but for some specific knee
replacement implant types, some considerations, not specifically covered in this document, 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 7207-1:2007, Implants for surgery — Components for partial and total knee joint prostheses — Part 1:
Classification, definitions and designation of dimensions
ISO 7207-2, Implants for surgery — Components for partial and total knee joint prostheses — Part 2:
Articulating surfaces made of metal, ceramic and plastics materials
ISO 14243-1, Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and
displacement parameters for wear-testing machines with load control and corresponding environmental
conditions for test
ISO 14243-2, Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
ISO 14243-3, Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and
displacement parameters for wear-testing machines with displacement control and corresponding
environmental conditions for test
ISO 14243-5, Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of
the patellofemoral joint
ISO 14630, Non-active surgical implants — General requirements
ISO 14879-1, Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance
properties of knee tibial trays
ISO 17853, Wear of implant materials — Polymer and metal wear particles — Isolation and characterization
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ISO 21534:2007, Non-active surgical implants — Joint replacement implants — Particular requirements
ASTM F1223, Standard Test Method for Determination of Total Knee Replacement Constraint
ASTM F1672-14(2019), Standard Specification for Resurfacing Patellar Prosthesis
ASTM F1877, Standard Practice for Characterization of Particles
ASTM F2083-21, Standard Specification for Knee Replacement Prosthesis
ASTM F2722, Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
ASTM F2723, Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing
Resistance to Dynamic Disassociation
ASTM F2724, Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
ASTM F2777, Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation
Under High Flexion
3 Terms and definitions
For the purposes of this document the terms and definitions in ISO 21534 and ISO 7207-1 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
— IEC Electropedia: available from https:// www .electropedia .org/
3.1
femoral component
component of a total, patella-femoral or uni-compartmental knee joint prosthesis intended to be
secured to the femur to replace its articulating surface(s)
Note 1 to entry: From ISO 7207-1: 2007. 3.2.3
3.2
mobile-bearing component
component of a total or uni-compartmental mobile-bearing knee joint prosthesis which articulates
with both the femoral component and the tibial tray
Note 1 to entry: From ISO 7207-1:2007, 3.2.10
Note 2 to entry: The mobile-bearing component can be manufactured as one component or a set of components,
in both cases intended to be assembled in the mobile-bearing knee joint prosthesis by the user.
Note 3 to entry: The mobile-bearing component is usually a sub-component of the tibial component, supported
by the tibial tray.
Note 4 to entry: The mobile-bearing component can also be referred to as the meniscal component.
3.3
mobile-bearing knee joint prosthesis
total or uni-compartmental knee joint prosthesis which allows relative motion between the mobile-
bearing component and both the femoral component and the tibial tray
Note 1 to entry: From ISO 7207-1:2007, 3.1.6
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3.4
patellar component
component of a total or patella-femoral knee joint prosthesis which is used to replace the articulating
surface of the patella
Note 1 to entry: From ISO 7207-1:2007, 3.2.13
Note 2 to entry: Patellar components can be monobloc or modular
3.5
patellar tray
sub-component of a modular patellar component used to support and secure the patellar insert
Note 1 to entry: Derived from ISO 7207-1:2007, 3.2.14
3.6
posterior stabilized tibial insert
A tibial insert with a centre post protruding superiorly or some other mechanism which interfaces with
the femoral component to restrict anterior translation of the femoral component when the knee is in
flexion.
Note 1 to entry: The portion of the femoral component interfacing with the tibial insert centre post is sometimes
referred to as the “cam”.
3.7
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, without
known or reasonably known evidence of device-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 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.
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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.
3.8
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 of a legally-marketed hip replacement implant system
for which there is not sufficient evidence to demonstrate sufficient and safe clinical use.
Note 5 to entry: Identification of a device with sufficient and safe clinical use is at the discretion of the
manufacturer and regulatory body in accordance with the regulatory requirements in the jurisdictions where
the device is marketed.
3.9
tibial component
component of a total or uni-compartmental knee joint prosthesis intended to be secured to the tibia to
replace its articulating surface(s)
Note 1 to entry: From ISO 7207-1:2007, 3.2.5
Note 2 to entry: Tibial components can be monobloc or modular. When modular the tibial component usually
consists either of a tibial insert (3.10) or a mobile-bearing component (3.2); and a tibial tray (3.11)
3.10
tibial insert
sub-component of a modular tibial component of a total or uni-compartmental knee joint prosthesis
which is attached to the tibial tray and which articulates with the femoral component
Note 1 to entry: From ISO 7207-1:2007, 3.2.9
3.11
tibial tray
sub-component of a modular tibial component of a total or uni-compartmental knee joint prosthesis
used to support the tibial insert or mobile-bearing component
Note 1 to entry: From ISO 7207-1:2007, 3.2.8
Note 2 to entry: The tibial tray is also referred to as the tibial baseplate
Note 3 to entry: The central stem or other prominence on the inferior surface of the tibial tray is also referred to
as the keel.
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3.12
total knee joint prosthesis
bi-compartmental or tri-compartmental knee joint prosthesis
Note 1 to entry: From ISO 7207-1:2007, 3.1.1
Note 2 to entry: Bi-compartmental refers to the replacement of the medial and lateral compartments of the knee
without resurfacing the patella
Note 3 to entry: Derived from ISO 7207-1:2007, 3.1.3
Note 4 to entry: Tri-compartmental refers to the replacement of the medial and lateral compartments of the knee
and also the patella-femoral compartment
Note 5 to entry: Derived from ISO 7207-1:2007, 3.1.4
3.13
UHMWPE
ultra-high molecular weight polyethylene.
Note 1 to entry: This term includes the following types of polyethylene-based materials: 1) conventional
UHMWPE (not intentionally cross-linked), 2) crosslinked UHMWPE achieved by radiation treatment or other
means and 3) crosslinked or not crosslinked UHMWPE with the addition of Vitamin E or another anti-oxidant.
3.14
uni-compartmental knee joint prosthesis
set of implant components used to replace the femoral and tibial articulating surfaces in either the
medial or the lateral compartment of a knee joint
Note 1 to entry: From ISO 7207-1:2007, 3.1.2.
Note 2 to entry: A uni-compartmental knee joint prosthesis is also referred to as a unicondylar knee joint
prosthesis
3.15
worst case
designation given 1) to an implant component or combination of components in an implant family most
susceptible to failure in a given test (e.g. based on size, geometry, design features, materials, means of
fixation, surface treatments or coatings, modularity); and, 2) to testing condition(s) which produce the
most severe anticipated physiological condition(s) or failure mode(s) for the requirements to which the
implant is under evaluation
Note 1 to entry: For any given implant component or combination of components or set of testing conditions,
there can be more than one worst case.
Note 2 to entry: For any modification to the device design or change in compatibility with other components, the
design should be assessed to determine if a new worst case(s) is created for a given test.
4 Intended performance
The requirements of this clause 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.
The requirements of ISO 21534:2007, Clause 4, shall apply together with the following.
The intended range of angular movement between the skeletal parts referred to in ISO 21534:2007,
Clause 4a), shall be determined.
NOTE 1 Further details for range of angular movement measurement can be found in ASTM F2083-21,
paragraph 6.5.
NOTE 2 Annex A gives a suitable method by which the range of motion between the femoral and tibial
components of a fully constrained total knee joint replacement can be measured.
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5 Design attributes
5.1 General
The requirements of this clause 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.
The design attributes, to meet the intended performance, shall conform to the requirements of Clause 5
of ISO 21534: 2007, and those specified in 5.2, 5.3 and 5.4 to meet the intended use.
In addition, account shall be taken of at least the following points, if applicable:
a) the tibial and femoral intramedullary stem length and diameter,
b) the dimensions of the tibial tray including the width, depth, thickness, minimum thickness; and, the
dimensions of the keel including the medial/lateral and anterior/posterior dimensions,
c) dimensions of the femoral component including the width, depth, height (anterior and posterior),
thickness and minimum thickness (anterior, posterior and distal), intracondylar depth,
intercondylar notch width radius/radii of curvature of the articulating surface, and any other
critical dimensions,
d) dimensions of the tibial and patella components including the width, depth, thickness, minimum
thickness, radius/radii of curvature of the articulating sur
...
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