SIST EN ISO 16061:2015

SLOVENSKI STANDARD
SIST EN ISO 16061:2015
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
SIST EN ISO 16061:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16061:2015

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SIST EN ISO 16061:2015

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.

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SIST EN ISO 16061:2015
EN ISO 16061:2015 (E)
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
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SIST EN ISO 16061:2015
EN ISO 16061:2015 (E)
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.
3

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SIST EN ISO 16061:2015
EN ISO 16061:2015 (E)
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)
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SIST EN ISO 16061:2015
EN ISO 16061:2015 (E)
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.
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SIST EN ISO 16061:2015

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SIST EN ISO 16061:2015
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

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SIST EN ISO 16061:2015
ISO 16061:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 16061:2015
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 . 7
11.7 Instruments intended for single use . 7
Annex A (informative) Examples of typical instrument applications, together with
materials found acceptable for instrument manufacture . 8
Bibliography .17
© ISO 2015 – All rights reserved iii

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SIST EN ISO 16061:2015
ISO 16061:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 150, Implants for surgery.
This third edition cancels and replaces the second edition (ISO 16061:2008), which has been
technically revised.
iv © ISO 2015 – All rights reserved

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SIST EN ISO 16061:2015
INTERNATIONAL STANDARD ISO 16061:2015(E)
Instrumentation 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, 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 8601, Data elements and interchange formats — Information interchange — Representation of
dates and times
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 80000-1, Quantities and units — Part 1: General
© ISO 2015 – All rights reserved 1

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SIST EN ISO 16061:2015
ISO 16061:2015(E)

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
associated implant
specific non-active surgical implant in association with which a specific surgical instrument is intended
to be used during a surgical procedure
3.2
instrument
non-active medical device intended for use during surgical procedures related to a specific non-active
surgical implant
3.3
resupplied instrument
instrument or set of instruments that has been returned to the manufacturer and has been re-issued
4 Intended performance
The intended performance of an instrument shall be described and documented by addressing the
following, with particular regard to safety:
a) functional characteristics; and
b) intended conditions of use.
Account should be taken of:
— published standards;
— published clinical and scientific literature;
— validated test results.
The extent to which the intended performance of an instrument has been achieved shall be determined
(see Clause 7).
5 Design attributes
The development of the design attributes of an instrument to meet the performance intended by the
manufacturer shall take into account at least the following:
a) physical, mechanical, and chemical properties of the instrument materials (see Clauses 6 and 7);
b) microbiological and particulate contamination levels (see Clauses 7, 9, and 10);
c) ease of use, cleaning, and maintenance (see Clause 7);
d) potential deterioration of the material characteristics due to sterilization and storage (see
Clauses 6, 7, and 8);
e) effects of contact between the instrument and body, the implant, and other instruments (see Clause 7);
f) shape and dimensions of the instrument, including their possible effects on the body (see Clause 7);
g) wear characteristics of materials and the effect of wear and wear products on the instrument and
the body (see Clauses 6 and 7);
h) insertion, removal, and interconnection of parts (see Clause 7);
2 © ISO 2015 – All rights reserved

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SIST EN ISO 16061:2015
ISO 16061:2015(E)

i) extent of fluid leakage and/or diffusion of substances into or out of instruments (see Clauses 6 and 7);
j) accuracy and stability of instruments with a measuring function (see Clauses 7 and 8);
k) ability of the instrument or fragment of instrument to be located by means of an external imaging
device (see 11.3 p); and
l) compatibility with any medicinal substances incorporated into or used with the instrument.
6 Selection of materials
Materials for the manufacture of instruments shall be selected with regard to the properties required
for the intended purpose, taking into account the effects of manufacture, handling, sterilization, and
storage, as well as any treatment (chemical, electro-chemical, thermal, mechanical, etc.) applied to the
surface or a part of the surface of the instrument in order to modify its properties. Possible reactions of
instrument materials with human tissues and body fluids shall be considered (see Clause 7).
The suitability of a given material for a particular application shall be demonstrated by either
a) documented assessment in accordance with ISO 10993-1, or
b) selection from the materials found suitable by proven clinical use in similar applications.
NOTE Annex A lists some of the materials that have been found acceptable in certain applications.
7 Design evaluation
7.1 General
Instruments shall be evaluated in association with the implant they are designed for, in order to
demonstrate that the intended performance is achieved (see Clause 4). Safety shall be demonstrated by
pre-clinical evaluation and by carrying out a risk analysis in accordance with ISO 14971.
7.2 Pre-clinical evaluation
If pre-clinical testing of instruments is required, the testing shall simulate conditions of intended use.
7.3 Clinical evaluation
If a clinical evaluation is required, it shall be based on the following:
a) critical evaluation of the relevant scientific and clinical literature relating to the safety, performance,
design characteristics, and intended use of the instrument or demonstrably similar instruments; or
b) critical evaluation of the results of all clinical investigations conducted using the associated implant
under the intended conditions of use; or
c) combination of the clinical data provided in a) and b) above.
Where a clinical investigation is carried out, it shall be managed in accordance with ISO 14155.
8 Manufacture
Instruments shall be manufactured to specifications in accordance with the required design attributes
(see Clause 5).
© ISO 2015 – All rights reserved 3

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SIST EN ISO 16061:2015
ISO 16061:2015(E)

9 Sterilization
9.1 Products supplied sterile
For terminally sterilized instruments to be designated “STERILE”, the theoretical probability of there
−6
being a viable microorganism present on or in the instrument shall be equal to or less than 1 × 10 .
Manufacturers may use other sterility assurance levels, provided that this is justified by a documented
risk assessment.
If instruments are to be sterilized by ethylene oxide, it shall be done according to ISO 11135.
If instruments are to be sterilized by irradiation, it shall be done according to ISO 11137-1, ISO 11137-2,
and ISO 11137-3.
If instruments are to be sterilized by moist heat, it shall be done according to ISO 17665-1.
9.2 Products provided non-sterile
For instruments that are supplied non-sterile, the manufacturer shall specify at least one appropriate
sterilization method such that the functional safety of the product is not adversely affected. If multiple
sterilizations are not allowed, this shall be stated.
For instruments that are supplied non-sterile or claimed to be resterilizable, the manufacturer shall
provide information on the processing of these instruments in accordance with ISO 17664.
10 Packaging
10.1 Protection from damage in storage and transport
For each instrument, the packaging shall be designed so that, under conditions specified by the
manufacturer for storage, transport, and handling (including control of temperature, humidity, and
ambient pressure, if applicable), the instrument is protected against damage and deterioration and the
packaging does not adversely affect the intended performance of the instrument.
NOTE Possible test methods are specified in IEC 60068–2-27, IEC 60068–2-31, and/or IEC 60068–2-47.
10.2 Maintenance of sterility in transit
Instruments labelled “STERILE” shall be packaged such that they remain sterile under normal storage,
transport, and handling conditions, unless the protective package is damaged or opened.
The packaging shall comply with ISO 11607-1 and ISO 11607-2.
11 Information supplied by the manufacturer
11.1 General
Information supplied by the manufacturer and intended for direct visual recognition shall be legible
when viewed under illumination of 215 lx using normal vision, corrected if necessary, at a distance that
takes into account the form and size of the individual instrument.
If there is insufficient space on each instrument’s individual packaging, the relevant information may be
given on an insert, accompanying document, or on the next layer of packaging, as applicable.
The recognition of certain markings on small or specialized instruments might require the use of
methods other than visual, e.g. electronic methods.
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SIST EN ISO 16061:2015
ISO 16061:2015(E)

When appropriate, symbols, abbreviations, and identification colour may be used in the markings and
accompanying documents of an instrument. Any symbols, abbreviations, and identification colours
used shall conform to published International Standards (e.g. ISO 15223-1). Where no such standards
exist, the manufacturer shall describe the symbols, abbreviations, or identification colours used in the
documentation supplied with the instrument.
The information supplied by the manufacturer shall not be presented in such a manner that it can be
confused with other essential information and shall be understandable by the intended user and/or
other persons, where appropriate.
Any units of measurement shall be expressed in SI units complying with ISO 80000-1. Equivalent units
may be stated in parentheses.
As far as practicable and appropriate, the information needed to use the instrument safely shall be set
out on the instrument itself and/or on the packaging for each unit or, where appropriate, on the sales
packaging. If individual packaging of each unit is not practicable, the information shall be set out in the
leaflet supplied with each instrument or package.
When applicable, instruments with user adjustable controls shall have their function clearly specified.
Any detachable components, intended by the manufacturer to be used separately from the original
instrument, shall be identified by their batch code or by other appro
...