EN ISO 16061:2015
(Main)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
ISO 16061:2015 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, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2015)
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, Werkstoffe, 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 16061:2015)
L'ISO 16061:2015 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 16061:2015 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 16061:2015 donne les exigences relatives aux performances prévues, aux caractéristiques de conception, aux mat §ériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage, et aux informations fournies par le fabricant.
L'ISO 16061:2015 ne s'applique pas aux instruments associés aux implants dentaires, aux implants transendodontiques et transradiculaires, et aux implants ophtalmiques.
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) - Splošne zahteve (ISO 16061:2015)
Ta mednarodni standard določa posebne splošne zahteve za instrumente, ki se uporabljajo pri neaktivnih kirurških vsadkih. Te zahteve veljajo za instrumente, ko so proizvedeni in ko so znova dobavljeni po obnovi. Ta mednarodni standard velja tudi za instrumente, ki so morda priključeni na električni sistem, vendar pa ne velja za same električne sisteme. V zvezi z varnostjo ta mednarodni standard podaja zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec. Ta mednarodni standard se ne uporablja za instrumente, ki so povezani z dentalnimi vsadki, transendodontskimi in transradikularnimi vsadki in oftalmološkimi vsadki.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN ISO 16061:2009
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) -
Splošne zahteve (ISO 16061:2015)
Instrumentation for use in association with non-active surgical implants - General
requirements (ISO 16061:2015)
Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen (ISO 16061:2015)
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs -
Exigences générales (ISO 16061:2015)
Ta slovenski standard je istoveten z: EN ISO 16061:2015
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
May 2015
ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2009
English Version
Instrumentation for use in association with non-active surgical
implants - General requirements (ISO 16061:2015)
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
16061:2015) Anforderungen (ISO 16061:2015)
This European Standard was approved by CEN on 12 March 2015.
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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16061:2015 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 on medical devices .4
Foreword
This document (EN ISO 16061:2015) 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 November 2015, and conflicting national standards shall be withdrawn
at the latest by November 2015.
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 16061:2009.
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(s).
For relationship with EU 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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16061:2015 has been approved by CEN as EN ISO 16061:2015 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
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 Union 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.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 International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs)
Qualifying remarks/Notes
International Standard of Directive 93/42/EEC
7.3 6a
6 7.1, 1. indent
6 7.1, 2. indent
10.1 7.2 In respect of packaging only
6 7.3
5 i) 7.5
5 i) 7.6
5 b) and 6 8.1
10.2 8.3 In respect of packaging only
9.1 8.4
5 b) 8.5
10.1 8.6
9.1, 9.2, 10.2 and 11.3 i) 8.7
11.3 f) and 11.5 9.1
5 f) and 7.1 9.2, 1. indent
7.1 9.2, 2. indent
11.2 10.1
11.1, 11.4 and 11.5 13.1
11.1 13.2
11.2 b) 13.3 (a) The part of ER 13.3 (a)
concerning the information on the
manufacturer's authorized
representative in the European
Community is not addressed in
this European Standard
11.2 c) 13.3 (b)
11.2 e) 13.3 (c) This European Standard is not
applicable to power-driven
systems, so ER 13.3 (l) is not
applicable.
11.2 c) 13.3 (d)
11.2 g) and 11.1 13.3 (e)
11.2 h) 11.7 13.3 (f) ER: 13.3 (f) is only partially
addressed in this European
Standard. The safety issue is
addressed, but not the regulatory
requirement that the
manufacturer's indication of single
use must be consistent across the
European community.
11.2 i) 13.3 (i)
11.2 j) 13.3 (j)
11.2 e) 13.3 (m)
11.2 d) and 11.3 d) 13.4
113 b), 11.3 c), 11.3 h), 11.3 k), 13.6 (a) The part of ER 13.6 (a)
13.3 n) concerning the information on the
manufacturer's authorized
representative in the European
Community is not addressed in
this European Standard.
The part of ER 13.6 (a)
concerning the regulatory
requirement that the
manufacturer's indication of single
use must be consistent across the
European community is not
addressed in this European
Standard.
11.3 e) 13.6 (b)
11.3 f) 13.6 (c)
11.3 g) 13.6 (d)
13.3 j) 13.6 (g)
11.3 k) 13.6 (h)
11.3 m) 13.6 (i)
11.3 a) 13.6 (j)
11.3 k) 13.6 (k)
11.3 o) 13.6 (l)
11.3 r) 13.6 (m)
11.3 q) 13.6 (n)
11.3 r) 13.6(o)
11.4 13.6 (p)
11.3 s) 13.6 (q)
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
Third edition
2015-05-15
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 16061:2015(E)
©
ISO 2015
ISO 16061:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
ISO 16061:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 2
5 Design attributes . 2
6 Selection of materials . 3
7 Design evaluation . 3
7.1 General . 3
7.2 Pre-clinical evaluation . 3
7.3 Clinical evaluation . 3
8 Manufacture . 3
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 . 4
11 Information supplied by the manufacturer . 4
11.1 General . 4
11.2 Labelling . 5
11.3 Instructions for use . 6
11.4 Instruments with measuring function . 7
11.5 Restrictions in combinations . 7
11.6 Marking on instruments .
...
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