EN ISO 16061:2009
(Main)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
ISO 16061:2008 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.
ISO 16061:2008 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, ISO 16061:2008 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, korr. Version 2009-03-15)
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 Bereit¬stellung 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, Version corrigés 2009-03-15)
L'ISO 16061:2008 spécifie les exigences générales relatives aux instruments à utiliser en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis après fabrication ou aux instruments refournis après remise en état.
L'ISO 16061:2008 s'applique également aux instruments pouvant être connectés à des systèmes motorisés mais elle ne s'applique pas aux systèmes eux-mêmes.
En matière de sécurité, l'ISO 16061:2008 fournit des exigences relatives aux performances prévues, à la conception, au choix des matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations à fournir par le fabricant.
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008, popravljena verzija 2009-03-15)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
1DGRPHãþD
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) -
Splošne zahteve (ISO 16061:2008, popravljena verzija 2009-03-15)
Instrumentation for use in association with non-active surgical implants - General
requirements (ISO 16061:2008, Corrected version 2009-03-15)
Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen (ISO 16061:2008, korr. Version 2009-03-15)
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs -
Exigences générales (ISO 16061:2008, Version corrigés 2009-03-15)
Ta slovenski standard je istoveten z: EN ISO 16061:2009
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 16061
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2008
English Version
Instrumentation for use in association with non-active surgical
implants - General requirements (ISO 16061:2008, Corrected
version 2009-03-15)
Instrumentation à utiliser en association avec les implants Instrumente die in Verbindung mit nichtaktiven
chirurgicaux non actifs - Exigences générales (ISO chirurgischen Implantaten verwendet werden - Allgemeine
16061:2008, Version corrigés 2009-03-15) Anforderungen (ISO 16061:2008, korr. Version 2009-03-15)
This European Standard was approved by CEN on 20 July 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 16061:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 16061:2008, corrected version 2009-03-15 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 16061:2009 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 February 2010, and conflicting national standards shall be withdrawn
at the latest by February 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 16061:2008.
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 93/42/EEC.
For relationship with EC Directive 93/42/EEC, 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 16061:2008, corrected version 2009-03-15 has been approved by CEN as a EN ISO
16061:2009 without any modification.
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/subclause of this Essential requirements (ERs) of Qualifying
International Standard EU Directive 93/42/EEC remarks/Notes
4 1, 2, 3, 4, 12
5 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, 7.5, 7.6, 8, Part of ER 1 relating to risk of use
9, 10.1, 12 error is not addressed by this
European Standard.
6 1, 2, 7.1
1, 2, 3, 4, 5, 6, 7, 9.1, 9.2, 12
7 Part of ER 7.1 relating to the results of
biophysical or modelling research is
not explicitly addressed by this
European Standard.
1, 2, 3, 4, 5, 7, 9, 12
1, 2, 3, 4, 7, 8.1, 8.3 to 8.7,
9 Part of ER 13.6 h) relating to single
13.3. c), 13.6 h) use is not addressed by this European
Standard.
1, 2, 4, 5, 7.2, 7.5, 7.6,
8.3, 8.6, 8.7
11 Part of ER 13.3 a) concerning the
information on the authorized
representative is not addressed in this
European Standard.
Part of ER 13.3 f) is only partially
addressed: Safety issue is addressed,
but not the regulatory requirement
(consistency around Europe).
Part of ER 13.6 h) relating to single
use is not addressed by this European
Standard.
ER 13.6 q) is not addressed by this
European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 16061
Second edition
2008-12-01
Corrected version
2009-03-15
Instrumentation for use in association
with non-active surgical implants —
General requirements
Instrumentation à utiliser en association avec les implants chirurgicaux
non actifs — Exigences générales
Reference number
ISO 16061:2008(E)
©
ISO 2008
ISO 16061:2008(E)
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ISO 16061:2008(E)
Contents 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)
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.
...
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