Dentistry - Fatigue test for endosseous dental implants (ISO 14801:2003)

Zahnheilkunde - Ermüdungsprüfung für enossale dentale implantate (ISO 14801:2003)

Diese Internationale Norm legt ein Verfahren für die Ermüdungsprüfung von einpfostigen enossalen dentalen Implantaten vom transmukosalen Typ fest. Das Verfahren ist am besten geeignet zum Vergleich von enossalen dentalen Implantaten mit unterschiedlichen Konstruktionen oder Größen.
Obwohl in diesem Verfahren die funktionelle Belastung eines dentalen Implantatkörpers und seiner vorgefertigten Abutments unter den Bedingungen des ?ungünstigsten Falls" simuliert wird, sollte es nicht dazu verwendet werden, die in vivo Leistungsfähigkeit eines dentalen Implantats oder eines Zahnersatzes vorauszusagen, insbesondere nicht für Anwendungen, bei denen multiple enossale dentale Implantate als Zahnersatz verwendet werden.

Art dentaire - Essai de fatigue pour implants dentaires endosseux (ISO 14801:2003)

L'IEC 60879:2019 spécifie les méthodes de mesure de l'aptitude à la fonction des ventilateurs de confort et des régulateurs de vitesse pour applications domestiques et analogues, notamment les ventilateurs conventionnels, les ventilateurs à colonne et les ventilateurs sans pales, présentant une tension assignée inférieure ou égale à 250 V pour les ventilateurs monophasés et inférieure ou égale à 480 V pour les autres ventilateurs, ainsi qu'une puissance absorbée nominale inférieure à 125 W.
Selon la méthode d'essai, les ventilateurs de confort se classent en deux groupes:
– ventilateurs sur pied, ventilateurs de table, ventilateurs muraux, ventilateurs rotatifs, ventilateurs à colonne, ventilateurs sans pales;
– ventilateurs de plafond.
Lorsqu'il y a lieu, le terme "ventilateur" employé dans le présent document couvre également son régulateur (si le ventilateur en est équipé d'un).
Le présent document ne s'applique pas à:
– la sécurité des ventilateurs électriques pour applications domestiques et analogues (IEC 60335-2-80);
– l'aptitude à la fonction des aérateurs (IEC 60665);
– la compatibilité électromagnétique des ventilateurs (CISPR 14-1 et CISPR 14-2, IEC 61000-3-2, IEC 61000 3-3).
Cette deuxième édition annule et remplace la première édition parue en 1986. Cette édition constitue une révision technique.
Cette édition comprend les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) les définitions des ventilateurs ont été révisées;
b) les méthodes d'essai des différents types de ventilateurs ont été révisées afin de permettre l'emploi d'appareils de mesure modernes;
c) des méthodes de mesure ont été ajoutées pour les mesurages du bruit acoustique et de la consommation d'électricité.

Dentistry - Fatigue test for endosseous dental implants (ISO 14801:2003)

General Information

Status
Withdrawn
Publication Date
31-Aug-2003
Withdrawal Date
02-Mar-2008
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
18-Feb-2008
Due Date
12-Mar-2008
Completion Date
03-Mar-2008

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SLOVENSKI STANDARD
SIST EN ISO 14801:2003
01-september-2003
Dentistry - Fatigue test for endosseous dental implants (ISO 14801:2003)
Dentistry - Fatigue test for endosseous dental implants (ISO 14801:2003)
Zahnheilkunde - Ermüdungsprüfung für enossale dentale implantate (ISO 14801:2003)
Art dentaire - Essai de fatigue pour implants dentaires endosseux (ISO 14801:2003)
Ta slovenski standard je istoveten z: EN ISO 14801:2003
ICS:
11.060.15
SIST EN ISO 14801:2003 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
May 2003
ICS 11.060.15
English version
Dentistry - Fatigue test for endosseous dental implants (ISO
14801:2003)
Art dentaire - Essai de fatigue pour implants dentaires Zahnheilkunde - Ermüdungsprüfung für enossale dentale
endosseux (ISO 14801:2003) implantate (ISO 14801:2003)
This European Standard was approved by CEN on 5 May 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14801:2003 E
worldwide for CEN national Members.

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EN ISO 14801:2003 (E)
CORRECTED  2003-09-24
Foreword
This document (EN ISO 14801:2003) 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 November 2003, and conflicting national
standards shall be withdrawn at the latest by November 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 14801:2003 has been approved by CEN as EN ISO 14801:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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EN ISO 14801:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory use - EN ISO 3696 1995
Specification and test methods
ISO 7500-1 1999 Metallic materials - Verification of static EN ISO 7500-1 1999
uniaxial testing machines - Part 1:
Tension/compression testing machines
3

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INTERNATIONAL ISO
STANDARD 14801
First edition
2003-05-15
Corrected version
2003-11-15


Dentistry — Fatigue test for endosseous
dental implants
Art dentaire — Essai de fatigue pour implants dentaires endosseux




Reference number
ISO 14801:2003(E)
©
ISO 2003

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ISO 14801:2003(E)
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ii © ISO 2003 — All rights reserved

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ISO 14801:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 General principles. 2
5 Test method. 2
6 Test report. 5
Annex A (informative) Load-cycle diagram. 7
Bibliography . 8

© ISO 2003 — All rights reserved iii

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ISO 14801:2003(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 corrected version of ISO 14801:2003 incorporates a change in 5.2.4 of the incorrect dimension 5 mm to
the correct dimension 50 mm.

iv © ISO 2003 — All rights reserved

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INTERNATIONAL STANDARD ISO 14801:2003(E)

Dentistry — 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. It is most useful for comparing endosseous dental implants of different designs or
sizes.
While it simulates the functional loading of an endosseous dental implant body and its premanufactured
prosthetic components under “worst-case” conditions, this International Standard is not applicable for
predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if multiple
endosseous dental implants are 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 1942-1, Dental vocabulary — Part 1: General and clinical terms
ISO 3696, Water for analytical laboratory use — Specification and test methods
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 International Standard, the terms and definitions given in ISO 1942-1 and the
following apply.
3.1
endosseous dental implant
device specially designed to be placed surgically within the bones surrounding the oral cavity, the primary
purposes of which are to support and to resist displacement of a dental 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 2003 — All rights reserved 1

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ISO 14801:2003(E)
3.2
endosseous dental implant body
primary single component or portion of an endosseous dental implant that is intended to remain within tissue
3.3
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
3.4
load-cycle diagram
diagram summarizing the fatigue properties of an endosseous dental implant by showing, for each value of
the applied load amplitude, 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 as the device
...

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