EN ISO 16061:2009

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

• Status: Withdrawn
• Publication Date: 04-Aug-2009
• Withdrawal Date: 19-May-2015
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 1 - General requirements for non active surgical implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 20-May-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 16061:2009 - Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

Relations

• Replaces: EN ISO 16061:2008 - Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
• Effective Date: 08-Aug-2009
• Replaced By: EN ISO 16061:2015 - Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
• Effective Date: 26-May-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16061:2009
01-oktober-2009
1DGRPHãþD
SIST EN ISO 16061:2009
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
SIST EN ISO 16061:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16061:2009

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SIST EN ISO 16061:2009


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.

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SIST EN ISO 16061:2009
EN ISO 16061:2009 (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 16061:2009
EN ISO 16061:2009 (E)
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 Int
...