SIST EN ISO 16061:2009
(Main)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
This International Standard specifies general requirements for instruments to be used in association with nonactive 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.
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
Relations
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 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.
3
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SIST EN ISO 16061:2009
EN ISO 16061:2009 (E)
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
8
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,
10
8.3, 8.6, 8.7
13
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.
4
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SIST EN ISO 16061:2009
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
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SIST EN ISO 16061:2009
ISO 16061:2008(E)
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Published in Switzerland
ii © ISO 2008 – All rights reserved
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SIST EN ISO 16061:2009
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 2008 – All rights reserved iii
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SIST EN ISO 16061:2009
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
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SIST EN ISO 16061:2009
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 2008 – All rights reserved 1
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SIST EN ISO 16061:2009
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
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SIST EN ISO 16061:2009
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 2008 – All rights reserved 3
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SIST EN ISO 16061:2009
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 met.
9 Sterilization
9.1 Products supplied sterile
Instruments which are labelled “STERILE” shall comply with EN 556-1 and EN 556-2.
Sterilization processes shall be validated and routinely controlled.
If instruments are to be sterilized by ethylene oxide, ISO 11135-1 applies.
If instruments are to be sterilized by irradiation, ISO 11137-1, ISO 11137-2 and ISO 11137-3 apply.
If instruments are to be sterilized by steam, ISO 17665-1 applies.
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 (see 11.6).
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), it protects against damage and deterioration and 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.
4 © ISO 2008 – All rights reserved
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SIST EN ISO 16061:2009
ISO 16061:2008(E)
10.2 Maintenance of sterility in transit
Instruments labelled “STERILE” shall be packed such that they remain sterile under normal storage, transport
and handling conditions, unless the protective package is damaged or opened.
The packaging shall conform to ISO 11607-1 and ISO 11607-2.
11 Information to be supplied by the manufacturer
11.1 General
Information supplied with instruments by manufacturers shall be in accordance with EN 1041. All packages
shall bear a label which indicates the full contents. If the label does not list the full contents of the package, a
contents list shall be enclosed. If symbols are to be used, they shall be in accordance with ISO 15223-1.
The manufacturer's address shall be included in the information supplied by the manufacturer.
NOTE 1 The European regulation requires the name and address of the authorized representative established in the
European Community.
NOTE 2 The European regulation requires that the date of issue or the latest revision of the instructions for use is
mentioned in the instructions for use.
11.2 Instruments with measuring function
The limits of accuracy of instruments having a measuring function shall be indicated by a marking on the
device and/or label, instruction leaflet or manual.
NOTE This requirement does not apply to gauges used for component size selection and GO/NO GO determination.
11.3 Restrictions in combinations
If the instrument is intended to be used in combination with other instruments, devices or equipment,
restrictions in the use of the combination shall be indicated on the label or in the instruction leaflet or the
manual.
11.4 Marking on instruments
Instruments shall be marked with the following:
⎯ manufacturer's name or trademark;
⎯ batch code or serial number, where appropriate;
⎯ catalogue/article number, where appropriate, and/or size indication if needed for safe selection or use.
If the marking would affect the intended performance, or the instrument is too small to be legibly marked, the
information required shall be given on the label.
11.5 Instructions for use
If the instrument cannot be used safely without instructions for use, these shall be provided. It shall be
indicated whether the instrument or any fragment thereof can be located by means of an external imaging
device, and with what kind of such device.
© ISO 2008 – All rights reserved 5
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SIST EN ISO 16061:2009
ISO 16061:2008(E)
11.6 Instruments intended for single use
Instruments intended for single use only shall be labelled either “For single use only” or by a symbol in
accordance with ISO 15223-1.
If the instrument bears an indication that it is for single use only, the instructions for use shall contain
information on known characteristics and technical factors known to the manufacturer that could pose a risk if
the instrument was to be re-used.
6 © ISO 2008 – All rights reserved
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SIST EN ISO 16061:2009
ISO 16061:2008(E)
Annex A
(informative)
Examples of typical instrument applications, together with materials
found acceptable for instrument manufacture
A.1 Invasive applications
A.1.1 Instruments with cutting edges
⎯ scissors;
⎯ needles;
⎯ knives;
⎯ cannulae;
⎯ chisels;
⎯ drill bits;
⎯ gouges;
⎯ broaches;
⎯ curettes;
⎯ sawblades;
⎯ burrs;
⎯ reamers;
⎯ trepans.
A.1.2 Instruments used as guides
⎯ cannulae;
⎯ saw guides;
⎯ drill guides;
⎯ aiming devices.
A.1.3 Instruments having implant contact
⎯ punches;
⎯ extractors;
© ISO 2008 – All rights reserved 7
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SIST EN ISO 16061:2009
ISO 16061:2008(E)
⎯ introducers;
⎯ impactors;
⎯ pullers;
⎯ trial implants;
⎯ drive connections.
A.1.4 Instruments having passive contact
⎯ retractors;
⎯ location guides;
⎯ spreaders;
⎯ sizers;
⎯ forceps;
⎯ measuring devices;
⎯ holders;
⎯ trial implants;
⎯ location pins.
A.1.5 Miscellaneous
⎯ vents;
⎯ brushes;
⎯ restrictors.
A.2 Non-invasive applications
⎯ external alignment guides;
⎯ handles.
A.3 Materials for invasive applications
A.3.1 Instruments with cutting edges
A.3.1.1 Stainless steels
See Tables A.1, A.2, A.3 and A.4.
ISO 5832-1, Implants for surgery — Metallic materials — Part 1: Wrought stainless steel;
ISO 5832-9, Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel.
8 © ISO 2008 – All rights reserved
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...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008)Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2008)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:FprEN ISO 16061kSIST FprEN ISO 16061:2009en01-junij-2009kSIST FprEN ISO 16061:2009SLOVENSKI
STANDARD
kSIST FprEN ISO 16061:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTFprEN ISO 16061March 2009ICS 11.040.40; 11.040.99Will supersede EN ISO 16061:2008
English VersionInstrumentation for use in association with non-active surgicalimplants - General requirements (ISO 16061:2008)Instrumentation à utiliser en association avec les implantschirurgicaux non actifs - Exigences générales (ISO16061:2008)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 285.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. FprEN ISO 16061:2009: EkSIST FprEN ISO 16061:2009
FprEN ISO 16061:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST FprEN ISO 16061:2009
FprEN ISO 16061:2009 (E) 3 Foreword The text of ISO 16061:2008 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 FprEN ISO 16061:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede 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. Endorsement notice The text of ISO 16061:2008 has been approved by CEN as a FprEN ISO 16061:2009 without any modification. kSIST FprEN ISO 16061:2009
FprEN ISO 16061:2009 (E) 4 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 International Standard Essential requirements (ERs) of EU Directive 93/42/EEC
Qualifying 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, 9, 10.1, 12 Part of ER 1 relating to risk of use error is not addressed by this European Standard.
6 1, 2, 7.1
7 1, 2, 3, 4, 5, 6, 7, 9.1, 9.2, 12 Part of ER 7.1 relating to the results of biophysical or modelling research is not explicitly addressed by this European Standard.
8 1, 2, 3, 4, 5, 7, 9, 12
9 1, 2, 3, 4, 7, 8.1, 8.3 to 8.7,
13.3. c), 13.6 h) Part of ER 13.6 h) relating to single use is not addressed by this European Standard.
10 1, 2, 4, 5, 7.2, 7.5, 7.6,
8.3, 8.6, 8.7
11 13 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. kSIST FprEN ISO 16061:2009
Reference numberISO 16061:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO16061Second edition2008-12-01Corrected version2009-03-15Instrumentation for use in association with non-active surgical implants — General requirements Instrumentation à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) © ISO 2008 – All rights reserved iiiContents 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
kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) iv © ISO 2008 – All rights reserved 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).
kSIST FprEN ISO 16061:2009
INTERNATIONAL STANDARD ISO 16061:2008(E) © ISO 2008 – All rights reserved 1Instrumentation 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 kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) 2 © ISO 2008 – All rights reserved 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). kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) © ISO 2008 – All rights reserved 35 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. kSIST FprEN ISO 16061:2009
ISO 16061:2008(E) 4 © ISO 2008 – All rights reserved 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 met. 9 Sterilization 9.1 Products supplied sterile Instruments which are labelled “STERILE” shall comply with EN 556-1 and EN 556-2. Sterilization processes shall be validated and routinely controlled. If instruments are to be sterilized by ethylene oxide, ISO 11135-1 applies. If instruments are to be sterilized by irradiation, ISO 11137-1, ISO 11137-2 and ISO 11137-3 apply. If instruments are to
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