EN ISO 16061:2008
(Main)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2008)
Diese Internationale Norm legt allgemeine Anforderungen für Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden, fest. Diese Anforderungen gelten für Instrumente während ihrer Herstellung und wenn sie nach Aufarbeitung wiedergeliefert werden.
Diese Norm gilt auch für Instrumente, die mit Antriebseinheiten verbunden werden können, aber gilt nicht für die Antriebseinheiten selbst.
In Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffauswahl, Designprüfung, Herstellung, Sterilisation, Verpackung und Bereitstellung von Informationen durch den Hersteller fest.
Diese Norm gilt nicht für Instrumente, die in Verbindung mit Dentalimplantaten, transendodontischen und transradikulären Implantaten sowie ophthalmologischen Implantaten verwendet werden.
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2008)
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008)Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2008)Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2008)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)11.040.30Operacijski instrumenti in materialiSurgical instruments and materialsICS:Ta slovenski standard je istoveten z:EN ISO 16061:2008SIST EN ISO 16061:2009en01-marec-2009SIST EN ISO 16061:2009SLOVENSKI
STANDARDSIST EN 12011:20001DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 16061December 2008ICS 11.040.40; 11.040.99Supersedes EN 12011:1998
English VersionInstrumentation for use in association with non-active surgicalimplants - General requirements (ISO 16061:2008)Instrumentation à utiliser en association avec les implantschirurgicaux non actifs - Exigences générales (ISO16061:2008)Instrumente die in Verbindung mit nichtaktivenchirurgischen Implantaten verwendet werden - AllgemeineAnforderungen (ISO 16061:2008)This European Standard was approved by CEN on 29 November 2008.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© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 16061:2008: ESIST EN ISO 16061:2009
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 16061:2009
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 to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC of 14 June 1993 concerning 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 normative clauses of this standard given in Table ZA.1 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 1— Correspondence between this European 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, 3, 2, 4, 12
5 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, 7.5, 7.6, 8, 9, 10.1, 12
6 1, 2, 7.1
7 1, 2, 3, 4, 5, 6, 7, 9.1, 9.2, 12
8 1, 2, 3, 4, 5, 7, 9, 12
9 1, 2, 3, 4, 7, 8.1, 8.3 to 8.7, 13.3. c), 13.6 h)
10 1, 2, 4, 5, 7.2, 7.5, 7.6, 8.3, 8.6, 8.7
11 13
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
Reference numberISO 16061:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO16061Second edition2008-12-01Instrumentation for use in association with non-active surgical implants — General requirements Instrumentation à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
ISO 16061:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2008 – All rights reserved
ISO 16061:2008(E) © ISO 2008 – All rights reserved iiiContents Page Foreword.iv 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Intended performance.2 5 Design attributes.3 6 Selection of materials.3 7 Design evaluation.3 7.1 General.3 7.2 Pre-clinical evaluation.4 7.3 Clinical evaluation.4 8 Manufacture.4 9 Sterilization.4 9.1 Products supplied sterile.4 9.2 Products provided non-sterile.4 10 Packaging.4 10.1 Protection from damage in storage and transport.4 10.2 Maintenance of sterility in transit.5 11 Information to be supplied by the manufacturer.5 11.1 General.5 11.2 Instruments with measuring function.5 11.3 Restrictions in combinations.5 11.4 Marking on instruments.5 11.5 Instructions for use.5 11.6 Instruments intended for single use.6 Annex A (informative)
Examples of typical instrument applications, together with materials found acceptable for instrument manufacture.7 Bibliography.18
ISO 16061:2008(E) iv © ISO 2008 – All rights reserved 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 16061 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second edition cancels and replaces the first edition (ISO 16061:2000), which has been technically revised.
INTERNATIONAL STANDARD ISO 16061:2008(E) © ISO 2008 – All rights reserved 1Instrumentation for use in association with non-active surgical implants — General requirements 1 Scope This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edi
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