SIST EN ISO 21535:2008
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)
Diese Internationale Norm legt spezielle Anforderungen an Implantate für den Hüftgelenkersatz fest. Mit Bezug auf die Sicherheit legt diese Norm Anforderungen an die vorgesehene Leistung, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2007)
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO 21535:2007)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO 21535:2007)Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2007)Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)Ta slovenski standard je istoveten z:EN ISO 21535:2007SIST EN ISO 21535:2008en11.040.40ICS:SIST EN 12563:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 21535:200801-april-2008
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 21535September 2007ICS 11.040.40Supersedes EN 12563:1998
English VersionNon-active surgical implants - Joint replacement implants -Specific requirements for hip-joint replacement implants (ISO21535:2007)Implants chirurgicaux non actifs - Implants deremplacement d'articulation - Exigences spécifiquesrelatives aux implants de remplacement de l'articulation dela hanche (ISO 21535:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen an Implantate fürden Hüftgelenkersatz (ISO 21535:2007)This European Standard was approved by CEN on 16 August 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21535:2007: E
EN ISO 21535:2007 (E) 2 Contents Page Foreword.3
EN ISO 21535:2007 (E) 3 Foreword This document (EN ISO 21535:2007) 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 March 2008, and conflicting national standards shall be withdrawn at the latest by March 2008. This document supersedes EN 12563:1998. 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 EC Directive(s). For relationship with EC Directive(s), 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 21535:2007 has been approved by CEN as a EN ISO 21535:2007 without any modification.
EN ISO 21535:2007 (E) 4
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.
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 International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2
6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, 9.2
7 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 14
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 Via ISO 14630 10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630 11 9.1, 13
NOTE
Clauses 4, 5, 6, 7, 8 and subclause 11.5 supplement and are dependent on the corresponding clauses of ISO 21534.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 21534:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO21534Second edition2007-10-01Non-active surgical implants — Joint replacement implants — Particular requirements Implants chirurgicaux non actifs — Implants de remplacement d'articulation — Exigences particulières
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ii © ISO 2007 – All rights reserved
ISO 21534:2007(E) © ISO 2007 – All rights reserved iiiContents 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 21534:2007(E) iv © ISO 2007 – All rights reserved Annex C (informative)
List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants.11 Bibliography.12
ISO 21534:2007(E) © ISO 2007 – All rights reserved vForeword 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 21534:2007(E) vi © ISO 2007 – All rights reserved 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.
INTERNATIONAL STANDARD ISO 21534:2007(E) © ISO 2007 – All rights reserved 1Non-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 ISO 14630:—1), 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 21534:2007(E) 2 © ISO 2007 – All rights reserved 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 acti
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