SIST EN ISO 14801:2008

SLOVENSKI STANDARD
SIST EN ISO 14801:2008
01-april-2008
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SIST EN ISO 14801:2003
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Dentistry - Implants - Dynamic fatigue test for endosseous dental implants (ISO
14801:2007)
Zahnheilkunde - Implantate - Dynamische Ermüdungsprüfung für enossale dentale
Implantate (ISO 14801:2007)
Art dentaire - Implants - Essai de fatigue dynamique pour implants dentaires endosseux
(ISO 14801:2007)
Ta slovenski standard je istoveten z: EN ISO 14801:2007
ICS:
11.060.15
SIST EN ISO 14801:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 14801
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2007
ICS 11.060.15 Supersedes EN ISO 14801:2003
English Version
Dentistry - Implants - Dynamic fatigue test for endosseous
dental implants (ISO 14801:2007)
Art dentaire - Implants - Essai de fatigue dynamique pour Zahnheilkunde - Implantate - Dynamische
implants dentaires endosseux (ISO 14801:2007) Ermüdungsprüfung für enossale dentale Implantate (ISO
14801:2007)
This European Standard was approved by CEN on 4 November 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14801:2007: E
worldwide for CEN national Members.

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EN ISO 14801:2007 (E)
Contents Page
Foreword.3

2

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EN ISO 14801:2007 (E)
Foreword
This document (EN ISO 14801:2007) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in
collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 May 2008, and conflicting national standards shall be withdrawn at the
latest by May 2008.
This document supersedes EN ISO 14801:2003.
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 14801:2007 has been approved by CEN as a EN ISO 14801:2007 without any modification.

3

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INTERNATIONAL ISO
STANDARD 14801
Second edition
2007-11-15


Dentistry — Implants — Dynamic fatigue
test for endosseous dental implants
Art dentaire — Implants — Essai de fatigue dynamique pour implants
dentaires endosseux




Reference number
ISO 14801:2007(E)
©
ISO 2007

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ISO 14801:2007(E)
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ii © ISO 2007 – All rights reserved

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ISO 14801:2007(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 14801 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants.
This second edition cancels and replaces the first edition (ISO 14801:2003) which has been technically
revised to include manufactured pre-angled connecting parts.

© ISO 2007 – All rights reserved iii

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INTERNATIONAL STANDARD ISO 14801:2007(E)

Dentistry — Implants — Dynamic fatigue test for endosseous
dental implants
1 Scope
This International Standard specifies a method of fatigue testing of single post endosseous dental implants of
the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing
endosseous dental implants of different designs or sizes.
While this International Standard simulates the functional loading of an endosseous dental implant body and
its premanufactured prosthetic components under “worst case” conditions, it is not applicable for predicting the
in vivo performance of an endosseous dental implant or prosthesis, particularly if more than one implant is
used for a prosthesis.
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 1099, Metallic materials — Fatigue testing — Axial force-controlled method
ISO 1942 (all parts), Dental vocabulary
ISO 4965, Axial load fatigue testing machines — Dynamic force calibration — Strain gauge technique
ISO 7500-1, Metallic materials — Verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Verification and calibration of the force-measuring system
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
endosseous dental implant system
device that consists of integrated components including the ancillary instruments and specific equipment
necessary for the clinical and laboratory preparation and placement of the implant, and for the construction
and insertion of the dependent prosthesis
NOTE 1 In addition to providing resistance to displacement of a dental prosthesis, an endosseous dental implant may
be used as an anchorage for orthodontic appliances.
NOTE 2 An endosseous dental implant may consist of one or more parts.
NOTE 3 The term dental prosthesis includes crowns and fixed and removable prostheses.
© ISO 2007 – All rights reserved 1

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ISO 14801:2007(E)
3.2
load-cycle diagram
diagram summarising the fatigue properties of an endosseous dental implant by showing for each value of the
applied peak load the number of cycles endured by each specimen at the time of failure
See Annex A.
4 General Principles
4.1 Finished device testing
Testing shall be performed on specimens that are representative of the finished device (i.e., components that
have undergone the same manufacturing process and sterilization as the device that is to be marketed). If the
manufacturer intends the endosseous dental implant to be sterilized by the clinician prior to surgery,
sterilization shall be carried out as specified in the manufacturer’s instructions for use before testing. However,
if there is evidence that the specified sterilization method has no significant effect on the properties of all the
materials of the specimens being tested, then sterilization is not necessary prior to testing.
4.2 Multi-part endosseous dental implants
A multi-part endosseous dental implant shall be tested as assembled according to its intended use.
An endosseous dental implant component recommended by its manufacturer to be used in conjunction with
components of another manufacturer shall be tested as assembled according to the recommending
manufacturer’s statement. Where a multi-part device is assembled by means of screw joints, then these shall
be used according to the manufacturer’s recommendations and shall be tightened to the manufacturer’s
recommended torque using the equipment (screw driver, torque wrench) which is provided together with the
implant system or using a device that provides torque within ± 5 % of the recommended value if no original
instruments are available. The tightening sequence shall be as recommended by the manufacturer.
4.3 Worst-case testing
If a part of the endosseous dental implant system is available in various dimensions and/or configurations,
testing shall be carried out for the worst-case conditions within the recommended use. The choice of worst
case shall be justified and documented.
5 Test methods
5.1 Testing machine
The testing machine shall:
⎯ be capable of applying the prescribed load with an error not exceeding ± 5 % at maximum load
(in accordance with ISO 7500-1 and ISO 4965);
⎯ be capable of applying the load at the prescribed frequency;
⎯ include instrumentation to monitor the values of maximum and minimum loads and loading frequency and
to detect failure of the specimen;
⎯ be capable of recording the number of loading cycles during the test.
2 © ISO 2007 – All rights reserved

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ISO 14801:2007(E)
5.2 Loading geometry
5.2.1 The loading force, F, (see Figures 1 and 2) of the testing machine shall be applied in such a way that:
⎯ no lateral constraint occurs;
⎯ the loading centre (Point C in Figures 1 and 2) is well-defined, such that the moment arm, y, can be
measured or calculated.
5.2.2 For dental implant systems that include no pre-angled connecting parts, these requirements will be
met by the test set-up shown schematically in Figure 1.
Dimensions in millimetres

Key
1 loading device [shall be allowed free movement transverse to loading direction (see 5.2.6)]
2 nominal bone level (see 5.3.2)
3 connecting part
4 hemispherical loading member
5 dental implant body
6 specimen holder
Figure 1 — Schematic of test set-up for systems with no pre-angled connecting parts
5.2.3 An endosseous dental implant from a system that includes no pre-angled connecting parts shall be
º º
clamped such that its axis makes a 30 ± 2 angle with the loading direction of the testing machine
(see Figure 1).
5.2.4 An endosseous dental implant body of a system that includes pre-angled connecting parts shall be
D
⎛⎞
º
+2
clamped such that the angl
...