SIST EN ISO 14801:2017
(Main)Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016)
Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016)
This International Standard specifies a method of dynamic testing of single post endosseous dental
implants of the transmucosal type in combination with their premanufactured prosthetic components.
It is most useful for comparing endosseous dental implants of different designs or sizes. This International Standard is not a test of the fundamental fatigue properties of the materials from which the endosseous implants and prosthetic components are made.
This International Standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments.
While this International Standard simulates the functional loading of an endosseous dental implant
under “worst case” conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.
Zahnheilkunde - Implantate - Dynamische Ermüdungsprüfung für enossale Dentalimplantate (ISO 14801:2016)
Médecine bucco-dentaire - Implants - Essai de charge dynamique pour implants dentaires endo-osseux (ISO 14801:2016)
ISO 14801:2016 spécifie une méthode d'essai dynamique des implants dentaires endo-osseux à pilier unique de type transmuqueux en combinaison avec leurs composants prothétiques préfabriqués. Elle est très utile pour comparer des implants dentaires endo-osseux de conception ou de tailles différentes. La présente Norme internationale ne constitue pas un essai des propriétés de fatigue fondamentales des matériaux de fabrication de l'implant endo-osseux et des composants prothétiques.
La présente Norme internationale ne s'applique pas aux implants dentaires présentant des longueurs endo-osseuses inférieures à 8 mm, ni aux fixations magnétiques.
Même si l'ISO 14801:2016 simule la mise en charge fonctionnelle, dans les conditions «les plus défavorables», d'un implant dentaire endo-osseux, elle n'est pas applicable pour prévoir le comportement in vivo d'un implant dentaire endo-osseux ou d'une prothèse dentaire, notamment si plusieurs implants dentaires endo-osseux sont utilisés pour une prothèse dentaire.
Zobozdravstvo - Vsadki (implantati) - Dinamični preskus obremenitev zobnih vsadkov (ISO 14801:2016)
Ta mednarodni standard določa metode dinamičnih preskusov obremenitev enojnih postendosalnih zobnih
vsadkov transmukoznega tipa v kombinaciji z vnaprej izdelanimi protetičnimi komponentami.
Najbolj uporaben je za primerjavo endosalnih zobnih vsadkov različnih zasnov ali velikosti. Ta mednarodni standard ni preskus osnovnih lastnosti utrujanja materialov, iz katerih so izdelani endosalni vsadki in protetične komponente.
Ta mednarodni standard se ne uporablja za zobne vsadke z endosalnimi dolžinami manj kot 8 mm ali magnetnimi priključki.
Čeprav ta mednarodni standard simulira funkcionalno obremenitev endosalnega zobnega vsadka
pri »najslabših možnih« pogojih, se ne uporablja za napovedovanje rezultatov in vivo pri endosalnih ali zobnih protezah, zlasti če je za zobno protezo uporabljenih več endosalnih zobnih vsadkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14801:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 14801:2008
=RER]GUDYVWYR9VDGNL LPSODQWDWL 'LQDPLþQLSUHVNXVREUHPHQLWHY]REQLK
YVDGNRY ,62
Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO
14801:2016)
Zahnheilkunde - Implantate - Dynamische Ermüdungsprüfung für enossale
Dentalimplantate (ISO 14801:2016)
Médecine bucco-dentaire - Implants - Essai de charge dynamique pour implants
dentaires endo-osseux (ISO 14801:2016)
Ta slovenski standard je istoveten z: EN ISO 14801:2016
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 14801:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14801:2017
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SIST EN ISO 14801:2017
EN ISO 14801
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 11.060.15 Supersedes EN ISO 14801:2007
English Version
Dentistry - Implants - Dynamic loading test for endosseous
dental implants (ISO 14801:2016)
Médecine bucco-dentaire - Implants - Essai de charge Zahnheilkunde - Implantate - Dynamische
dynamique pour implants dentaires endo-osseux (ISO Ermüdungsprüfung für enossale Dentalimplantate (ISO
14801:2016) 14801:2016)
This European Standard was approved by CEN on 28 August 2016.
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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14801:2016 E
worldwide for CEN national Members.
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SIST EN ISO 14801:2017
EN ISO 14801:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14801:2017
EN ISO 14801:2016 (E)
European foreword
This document (EN ISO 14801:2016) 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 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
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 14801:2007.
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 14801:2016 has been approved by CEN as EN ISO 14801:2016 without any modification.
3
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SIST EN ISO 14801:2017
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SIST EN ISO 14801:2017
INTERNATIONAL ISO
STANDARD 14801
Third edition
2016-11-01
Dentistry — Implants — Dynamic
loading test for endosseous dental
implants
Médecine bucco-dentaire — Implants — Essai de charge dynamique
pour implants dentaires endo-osseux
Reference number
ISO 14801:2016(E)
©
ISO 2016
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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
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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 2016 – All rights reserved
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principles . 2
4.1 Finished device testing . 2
4.2 Multi-part endosseous dental implants . 2
4.3 Worst-case testing . 2
5 Test methods . 3
5.1 Testing machine . 3
5.2 Loading geometry. 3
5.3 Specimen holder and load application . 6
5.4 Testing environment . 7
5.5 Loading frequency and wave form . 7
5.6 Procedure . 7
5.7 Alternative procedure — Stair case method . 8
6 Reporting . 9
Annex A (informative) Load-cycle diagram .11
Annex B (informative) Guide to determination of worst-case conditions .12
Bibliography .16
© ISO 2016 – All rights reserved iii
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SIST EN ISO 14801:2017
ISO 14801:2016(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 106 Dentistry, Subcommittee SC 8 Dental
implants.
This third edition cancels and replaces the second edition (ISO 14801:2007), which has been technically
revised.
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SIST EN ISO 14801:2017
INTERNATIONAL STANDARD ISO 14801:2016(E)
Dentistry — Implants — Dynamic loading test for
endosseous dental implants
1 Scope
This International Standard specifies a method of dynamic testing of single post endosseous dental
implants of the transmucosal type in combination with their premanufactured prosthetic components.
It is most useful for comparing endosseous dental implants of different designs or sizes. This
International Standard is not a test of the fundamental fatigue properties of the materials from which
the endosseous implants and prosthetic components are made.
This International Standard is not applicable to dental implants with endosseous lengths shorter than
8 mm nor to magnetic attachments.
While this International Standard simulates the functional loading of an endosseous dental implant
under “worst case” conditions, it is not applicable for predicting the in vivo performance of an
endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are
used for a dental prosthesis.
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 1942, Dentistry — Terminology
ISO 16443, Dentistry — Vocabulary for dental implants systems and related procedure
ISO 1099, Metallic materials — Fatigue testing — Axial force-controlled method
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 16443, 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 dental prosthesis
Note 1 to entry: In addition to providing resistance to displacement of an implant superstructure, an endosseous
dental implant may be used as an anchorage for orthodontic appliances.
Note 2 to entry: An endosseous dental implant may consist of one or more parts.
Note 3 to entry: The term implant superstructure includes crowns and fixed and removable prostheses, but
excludes implant abutments.
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
3.2
prosthetic components
implant components to be used for two part implant or multi-part implant
Note 1 to entry: Implant abutments, dental implant connecting parts, abutment screws, and implant connecting
part screws are used as prosthetic components in this International Standard.
3.3
endosseous dental implant assembly
dental implant assembly for endosseous dental implant
3.4
load-cycle diagram
diagram summarizing the dynamic loading 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
Note 1 to entry: See Annex A.
3.5
endosseous dental implant body
implant body of endosseous dental implant
4 General principles
4.1 Finished device testing
Testing shall be performed on specimens that are representative of the finished device (i.e. implant
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 (implant screwdriver, 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. Guidance on how to choose the worst case
is given in Annex B.
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
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),
— 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, and
— be capable of recording the number of loading cycles during the test.
5.2 Loading geometry
5.2.1 The loading force (see Figure 1 and Figure 2, arrow F) of the testing machine shall be applied in
such a way that
— no lateral constraint occurs,
— the position of the intersection of the loading axis (Line AB) with the axis of the endosseous dental
implant (Line DE), is well-defined, such that the moment arm (y) can be measured or calculated (see
Figure 1 and Figure 2).
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
5.2.2 An endosseous dental implant from a system that includes only straight implant abutments shall
be clamped such that its central longitudinal axis makes a 30° ± 2° angle with the loading direction of the
testing machine (see Figure 1).
Key
a
1 loading device
b
2 nominal bone level
3 implant abutment
4 hemispherical loading member
5 implant body
6 specimen holder
7 force application
a
Shall be allowed free movement transverse to loading
direction (see 5.2.5).
b
See 5.3.2.
Figure 1 — Schematic of test set-up for systems with no angulated implant abutments
5.2.3 An endosseous dental implant body of a system that includes angulated implant abutments shall
be clamped such that the angle with the loading direction of the testing machine is 10° + 2°/-1° greater
4 © ISO 2016 – All rights reserved
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
than the angle between the central longitudinal axis of the implant and the central longitudinal axis of
the angled-portion of the abutment, designated as α in Figure 2.
This represents a simulated undercorrection of 10°. The loading method shall be the same as that
shown in Figure 1. The loading centre shall be located at the intersection of the central longitudinal axis
of the free end of the abutment and the plane normal to the longitudinal axis of the implant and located
11 mm (Figure 2, l) from the support level of the implant.
Key
a
1 loading device
b
2 nominal bone level
3 implant abutment
4 hemispherical loading member
5 implant body
6 specimen holder
7 force application
a
Shall be allowed free movement transverse to loading
direction (see 5.2.5).
b
See 5.3.2.
Figure 2 — Schematic of test set-up for systems with angulated implant abutments
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SIST EN ISO 14801:2017
ISO 14801:2016(E)
5.2.4 The loading force (F) of the testing machine shall be applied through a deformation resistant
loading member with a hemispherical contact surface for load transfer, attached to or placed over the
free end of the implant abutment.
The yield strength and the hardness of the loading member should be higher than that of the member
that is used to apply the load. The loading centre, which is the centre of the hemisphere, shall be on the
central longitudinal axis of the endosseous dental implant or, for endosseous dental implant systems
which include angulated implant abutments, shall be on the central longitudinal axis of the free end of
the abutment.
5.2.5 The loading force shall be applied to the hemispherical loading surface by a loading device
(labelled 1 in Figure 1 and Fig
...
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