EN ISO 16061:2009

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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ii © ISO 2008 – All rights reserved

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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 16061 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first edition (ISO 16061:2000), which has been technically
revised.
In this corrected version of ISO 16061:2008 the normative reference to EN 1041 has been altered:
⎯ in Clause 2 (date deleted);
⎯ in subclause 11.1 (date and reference to 4.3 deleted).

iv © ISO 2008 – All rights reserved

INTERNATIONAL STANDARD ISO 16061:2008(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, selection of materials, design evaluation, manufacture, sterilization, packaging and information to
be 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 referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for 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 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 16061:2008(E)
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
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
EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 556-2, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 2: Requirements for aseptically processed medical devices
EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
associated instrument
instrument
non-active medical device intended for use during surgical procedures related to a specific non-active surgical
implant
3.2
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:
a) functional characteristics;
b) intended conditions of use.
NOTE 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).
2 © ISO 2008 – All rights reserved

ISO 16061:2008(E)
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);
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 11.5).
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
(see Clause 7).
The suitability of a given material for a particular application shall be demonstrated by either:
a) evaluating in accordance with Clause 7
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 (see Clause 4) is achieved. Safety shall be demonstrated by pre-clinical
evaluation and by carrying out a risk analysis in accordance with ISO 14971.
NOTE In certain circumstances, a clinical evaluation can also be required.
ISO 16061:2008(E)
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 conducted using the associated implant under the intended
conditions of use. Where a clinical investigation is carried out, it shall be managed in accordance with
ISO 14155-1 and ISO 14155-2.
8 Manufacture
Instruments shall be manufactured to specifications in accordance with the required design attributes
(see Clause 5).
NOTE 1 The application of quality systems as described in ISO 13485 might be appropriate.
NOTE 2 The design specification for re-supplied instruments need not necessarily be the same as the original,
provided that the requirements of this International Standard are m
...