SIST EN ISO 21534:2009
(Main)Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007)
Diese Internationale Norm legt besondere Anforderungen an Implantate für den totalen oder partiellen
Gelenkersatz, für künstliche Bänder und für Knochenzement fest, die im Folgenden als Implantate bezeichnet
werden. Für die Anwendung dieser Internationalen Norm werden künstliche Bänder und die zu ihnen
gehörenden Befestigungsmittel in den Begriff „Implantate“ eingeschlossen.
Sie legt Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung,
Herstellung, Sterilisation, Verpackung und Bereitstellung von Informationen durch den Hersteller fest.
Einige, zum Nachweis der Übereinstimmung mit dieser Internationalen Norm erforderlichen Prüfungen, sind in
den Normen der Ebene 3 enthalten oder dort als Verweise angeführt.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences particulières (ISO 21534:2007)
L'ISO 21534:2007 spécifie les exigences particulières relatives aux implants de remplacement total et partiel des articulations, aux ligaments artificiels, au ciment pour os, désignés «implants» ci-après. Pour les besoins de la présente Norme internationale, le terme «implant» englobe les ligaments artificiels et les dispositifs de fixation qui y sont associés, désignés ci-après «implants».
L'ISO 21534:2007 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.
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO 21534:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21534:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 21534:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve (ISO
21534:2007)
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO
21534:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen (ISO 21534:2007)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
particulières (ISO 21534:2007)
Ta slovenski standard je istoveten z: EN ISO 21534:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21534:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 21534:2009
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SIST EN ISO 21534:2009
EUROPEAN STANDARD
EN ISO 21534
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21534:2007
English Version
Non-active surgical implants - Joint replacement implants -
Particular requirements (ISO 21534:2007)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences particulières (ISO Gelenkersatz - Besondere Anforderungen (ISO
21534:2007) 21534:2007)
This European Standard was approved by CEN on 12 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21534:2009: E
worldwide for CEN national Members.
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SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
Foreword
The text of ISO 21534:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 21534:2009 by
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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21534:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 21534:2007 has been approved by CEN as a EN ISO 21534:2009 without any modification.
3
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SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN Directive 93/42/EEC
4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 The part of ER 1 relating to the risk
of use error is not addressed in this
European Standard.
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2 The part of ER 1 relating to the risk
of use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by this
European Standard.
6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, 9.2 The part of ER 1 relating to the risk
of use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results
of biophysical and modelling
research is not addressed by this
European Standard.
The part of ER 7.4 relating to the
regulatory provision for the
verification of the medicinal product
is not addressed in this European
Standard.
4
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SIST EN ISO 21534:2009
EN ISO 21534:2009 (E)
7 1, 2, 3, 4, 5, 6,, 6a., 7.1, 7.2, 7.3, The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results of
biophysical and modelling research is
not addressed by this European
Standard.
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard.
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 The part of ER 13.3 f is not addressed
in this European Standard.
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7
11 9.1, 13 The part of ER 13.3.a concerning the
information on the authorized
representative is not addressed in this
European Standard.
The ER 13.3 f is only partly addressed
in this European Standard: safety issue
of single use.
The part of ER 13.6.h) relating to single
use is not addressed in this European
Standard.
ER 13.6 q is not addressed in this
European Standard.
NOTE All clauses supplement and are dependent on the corresponding clauses of EN 14630
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 21534:2009
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SIST EN ISO 21534:2009
INTERNATIONAL ISO
STANDARD 21534
Second edition
2007-10-01
Non-active surgical implants — Joint
replacement implants — Particular
requirements
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences particulières
Reference number
ISO 21534:2007(E)
©
ISO 2007
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Intended performance . 2
5 Design attributes. 3
5.1 General. 3
5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight
polyethylene (UHMWPE) . 3
5.3 Surface finish of metallic or ceramic partial implants . 3
5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on
UHMWPE. 3
5.5 Surfaces of spherically-conforming metallic or ceramic partial implants. 3
5.6 Surfaces of concave, spherically-conforming UHMWPE components. 3
6 Materials . 4
6.1 General. 4
6.2 Dissimilar metals or alloys . 4
7 Design evaluation . 4
7.1 General. 4
7.2 Preclinical evaluation . 4
7.3 Clinical investigation. 5
7.4 Post market surveillance . 5
8 Manufacture and inspection . 5
8.1 General. 5
8.2 Metal surfaces . 5
8.3 Plastic surfaces. 5
8.4 Ceramic surfaces. 5
9 Sterilization. 6
9.1 General. 6
9.2 Expiry . 6
10 Packaging . 6
11 Information supplied by the manufacturer .6
11.1 General. 6
11.2 Labelling of implants for use on one side of the body only. 6
11.3 Instructions for orientation of implants. 6
11.4 Markings for orientation of the implants. 6
11.5 Placing of markings on implants . 6
11.6 Restrictions on use. 7
11.7 Re-sterilization of zirconia ceramics . 7
11.8 Labelling of implants for use with or without bone cement. 7
Annex A (informative) List of International Standards for materials found acceptable for the
manufacture of implants . 8
Annex B (informative) List of International Standards for materials found acceptable or not
acceptable for articulating surfaces of implants. 9
© ISO 2007 – All rights reserved iii
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
Annex C (informative) List of materials found acceptable or non-acceptable for metallic
combinations for non-articulating contacting surfaces of implants . 11
Bibliography . 12
iv © ISO 2007 – All rights reserved
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SIST EN ISO 21534:2009
ISO 21534:2007(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 21534 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.
This second edition cancels and replaces the first edition (ISO 21534:2002), which has been technically
revised.
© ISO 2007 – All rights reserved v
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
Introduction
There are three levels of International Standard 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 International Standard is a level 2 standard and contains requirements that apply to all non-active
surgical implants in the family of joint replacement implants.
The level 1 standard 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 1 standard has been
published as ISO 14630.
Level 3 standards apply to specific types of implants within a family, such as knee and hip joints. To address
all requirements, it is recommended that a standard of the lowest available level be consulted first.
vi © ISO 2007 – All rights reserved
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SIST EN ISO 21534:2009
INTERNATIONAL STANDARD ISO 21534:2007(E)
Non-active surgical implants — Joint replacement implants —
Particular requirements
1 Scope
This International Standard specifies particular requirements for total and partial joint replacement implants,
artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International
Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
It specifies requirements for intended performance, design attributes, materials, design evaluation,
manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Some tests required to demonstrate conformance to this International Standard are contained in or referenced
in level 3 standards.
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 4287, Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions
and surface texture parameters
ISO 7206-4, Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of
endurance properties of stemmed femoral components
ISO 7206-8, Implants for surgery — Partial and total hip joint prostheses — Part 8: Methods of determining
endurance performance of stemmed femoral components
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
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 tests
ISO 14242-2, Implants for surgery — Wear of total hip joint prostheses — Part 2: Methods of measurement
ISO 14243-2, Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
1)
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
1) To be published. (Revision of ISO 14630:2005)
© ISO 2007 – All rights reserved 1
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions in ISO 14630 together with the following apply.
3.1
artificial ligament
device, including its necessary fixing devices, intended to augment or replace the natural ligament
3.2
joint replacement implant
implantable device, including ancillary implanted components and materials, intended to provide function
similar to a natural joint and which is connected to the corresponding bones
3.3
mean centre
position within the spherical head for which the average of the distances to a set of points uniformly distributed
over the surface of the sphere is minimum
3.4
radial separation value
difference between the mean radius of the spherical surface and the radius to the point on the spherical
surface furthest from the mean centre
NOTE The units of the radial separation value are in micrometres.
4 Intended performance
For the purpose of this International Standard, the intended performance of implants shall conform to Clause 4
of ISO 14630:—, and the design input shall additionally address the following matters:
a) intended minimum and maximum relative angular movement between the skeletal parts to which the joint
replacement implant is attached;
b) expected maximum load actions (forces and moments) to be transmitted to the bony parts to which the
joint replacement implant is attached;
c) dynamic response of the body to the shape/stiffness of the implants;
d) expected wear of articulating surfaces;
e) suitability of the dimensions and shape of the implant for the population for which it is intended;
f) strength of the adhesion and durability of surface coatings or surface treatments.
NOTE 1 The clinical indications and contra-indications for the use of a particular implant are complex and should be
reviewed by the surgeons when they are selecting implants to be used for particular patients, relying upon their own
personal judgment and experience.
NOTE 2 The lifetime of an implant depends on the interaction of various factors; some are the responsibility of the
manufacturer, some, such as the implantation technique, are the responsibility of the surgeon in conducting the operation,
and some relate to the patient, for example, the biological and physiological response to the implant, the medical condition
of the patient, the conduct of the patient in respect of increasing body weight, carriage of heavy loads and adopting a high
level of physical activity.
2 © ISO 2007 – All rights reserved
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
5 Design attributes
5.1 General
The development of the design attributes to meet the performance intended by the manufacturer shall
conform to the requirements of Clause 5 of ISO 14630:—, and in addition, account shall be taken of the
following points:
a) the strength of adhesion and durability of surface coatings and surface treatments;
b) the wear of the articulating and other surfaces;
c) stability of the implant while allowing prescribed minimum and maximum relative movements between the
skeletal parts;
d) avoidance of cutting or abrading tissue during function other than insertion or removal;
e) the creep resistance and rupture characteristics, particularly as they relate to ligaments.
NOTE 1 Methods of assessment of the wear of articulating and other surfaces are prescribed in, e.g. ISO 14242-2 and
ISO 14243-1, -2 and -3.
NOTE 2 More specific requirements, such as that for hip joint replacements, might appear in other standards.
5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-
weight polyethylene (UHMWPE)
The articulating surfaces of metallic or ceramic components of total joint replacements intended to articulate
on UHMWPE shall have a surface roughness value Ra no greater than 0,1 µm (when measured in
accordance with 7.2.2).
5.3 Surface finish of metallic or ceramic partial implants
The articulating surface of metallic or ceramic components of partial joint replacements shall have a surface
roughness value Ra no greater than 0,5 µm (when measured in accordance with 7.2.2).
5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on
UHMWPE
The articulating surface of convex spherically conforming metallic or ceramic components of total joint
replacements intended to articulate on UHMWPE shall have a surface roughness Ra no greater than 0,05 µm
and a radial separation value for sphericity no greater than 10 µm (when measured in accordance with 7.2.2
and 7.2.3).
5.5 Surfaces of spherically-conforming metallic or ceramic partial implants
The articulating surface of spherically conforming metallic or ceramic components of partial joint replacements
shall have a surface roughness value Ra no greater than 0,5 µm and a radial separation value for sphericity
no greater than 100 µm (when measured in accordance with 7.2.2 and 7.2.3).
5.6 Surfaces of concave, spherically-conforming UHMWPE components
The articulating surface of concave, spherically-conforming UHMWPE components of total joint replacements
shall have a surface roughness Ra no greater than 2 µm and a radial separation value for sphericity no greater
than 200 µm (when measured in accordance with 7.2.2 and 7.2.3).
© ISO 2007 – All rights reserved 3
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SIST EN ISO 21534:2009
ISO 21534:2007(E)
6 Materials
6.1 General
The requirements of Clause 6 of ISO 14630:— apply together with the particular requirement of 6.2 of the
present document.
NOTE 1 Annex A gives a list of International Standards for materials found acceptable through proven use for the
manufacture of implants or for use in association with implants.
NOTE 2 Annex B gives lists of International Standards for pairs of materials found acceptable or not acceptable
through proven use for articulating surfaces of implants.
NOTE 3 Where 6.1 of ISO 14630:— states that the acceptability of materials may be demonstrated by selection from
the materials found suitable by proven clinical use in similar applications, for the purposes of this International Standard,
proven use should be demonstrated by records of implantation of at least 500 of the implants and recorded satisfactory
clinical use over a period of not less than five years.
6.2 Dissimilar metals or alloys
For applications in which two dissimilar metals or alloys or the same metals or alloys in different metallurgical
states are in contact where articulation is not intended, combinations used shall not produce unacceptable
galvanic effects.
NOTE Annex C gives lists of International Standards for acceptable and unacceptable metallic combinations for use
in non-articulating bearing surfaces of implants.
7 Design evaluation
7.1 General
Joint replacement implants shall be evalua
...
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