EN ISO 16061:2021

SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST EN ISO 16061:2015
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) -
Splošne zahteve (ISO 16061:2021)
Instruments for use in association with non-active surgical implants - General
requirements (ISO 16061:2021)
Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen (ISO 16061:2021)
Instruments à utiliser en association avec les implants chirurgicaux non actifs -
Exigences générales (ISO 16061:2021)
Ta slovenski standard je istoveten z: EN ISO 16061:2021
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.

EN ISO 16061
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2021
EUROPÄISCHE NORM
ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2015
English Version
Instruments for use in association with non-active surgical
implants - General requirements (ISO 16061:2021)
Instruments à utiliser en association avec les implants Instrumente, die in Verbindung mit nichtaktiven
chirurgicaux non actifs - Exigences générales (ISO chirurgischen Implantaten verwendet werden -
16061:2021) Allgemeine Anforderungen (ISO 16061:2021)
This European Standard was approved by CEN on 5 January 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16061:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16061:2021) 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 September 2021, and conflicting national standards
shall be withdrawn at the latest by September 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 16061:2015.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16061:2021 has been approved by CEN as EN ISO 16061:2021 without any modification.

INTERNATIONAL ISO
STANDARD 16061
Fourth edition
2021-03
Instruments for use in association
with non-active surgical implants —
General requirements
Instruments à utiliser en association avec les implants chirurgicaux
non actifs — Exigences générales
Reference number
ISO 16061:2021(E)
©
ISO 2021
ISO 16061:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 16061:2021(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 2
5 Design attributes . 3
6 Selection of materials . 4
7 Design evaluation . 4
7.1 General . 4
7.2 Pre-clinical evaluation . 4
7.3 Clinical evaluation . 5
7.4 Post-market surveillance . 5
8 Manufacture . 6
9 Sterilization . 6
9.1 Instruments supplied sterile . 6
9.2 Instruments supplied non-sterile . 6
9.3 Instruments that are resterilizable . 6
10 Packaging . 6
10.1 Protection from damage in transport, storage and handling. 6
10.2 Maintenance of sterility in transport, storage and handling . 7
11 Information supplied by the manufacturer . 7
11.1 General . 7
11.2 Marking on instruments . 8
11.3 Label . 8
11.4 Instructions for use . 9
11.5 Additional information for instruments with a measuring function .10
Annex A (informative) Examples of typical applications of instruments to be used in
association with non-active surgical implants and materials found acceptable for
instrument manufacture .11
Bibliography .13
ISO 16061:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active
surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 16061:2015), which has been technically
revised. The main changes compared to the previous edition are as follows:
— A requirement to include intended purpose has been added in the list of items to be included when
establishing the intended performance of the instrument.
— The list of design attributes in Clause 5 has been reorganized and several new attributes have ad
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