EN ISO 16443:2014

Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)

ISO 16443:2014 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from ISO 16443:2014.
The following devices are also excluded from the scope of ISO 16443:2014.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions):
       epithesis implant;
       craniofacial implant;
       maxillofacial implant.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance:
       orthodontic implant.

Zahnheilkunde - Vokabular für Dentalimplantatsysteme und zugehörige Verfahren (ISO 16443:2014)

Dieses Dokument legt Begriffe für Dentalimplantate und für Instrumente, Zubehör sowie für die am häufigsten verwendeten klinischen Begriffe für Implantatsysteme und dazugehörige Verfahren in der Zahnheilkunde fest. Augmentationsmaterialien und Membranen sind von dieser Norm ausgenommen.
Die folgenden Produkte sind ebenfalls vom Anwendungsbereich dieses Dokuments ausgenommen.
Produkte, die speziell zum Einsetzen in den Knochen, durch den Knochen oder auf den Knochen des kraniofazialen Komplexes konstruiert wurden und hauptsächlich zur Verankerung einer Epithese dienen (als Ersatz zum Beispiel für Ohren, Nase, Teile der Augen und des Orbitalbereiches):
   Epithesenimplantat;
   kraniofaziales Implantat;
   maxillofaziales Implantat.
Produkte, die speziell zum Einsetzen in den Knochen, durch den Knochen oder auf den Knochen des kraniofazialen Komplexes konstruiert wurden und hauptsächlich zur Verankerung einer kieferorthopädischer Apparatur dienen:
   kieferorthopädisches Implantat.

Médecine bucco-dentaire - Vocabulaire des systèmes d'implants dentaires et procédures associées (ISO 16443:2014)

L'ISO 16443:2014 spécifie les termes et définitions relatifs aux implants dentaires, aux instruments et aux accessoires, ainsi que les termes cliniques les plus couramment employés en médecine bucco-dentaire dans le domaine des procédures et des systèmes implantaires. Les matériaux de greffe osseuse et les membranes ne sont pas traités dans l'ISO 16443:2014.
Les dispositifs suivants ne relèvent pas non plus du domaine d'application de l'ISO 16443:2014.
Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à une épithèse (pour remplacer par exemple les oreilles, le nez et certaines parties des yeux et des régions orbitales):
       implant pour épithèse;
       implant cranio-facial;
       implant maxillo-facial.
Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à un appareil orthodontique:
       implant orthodontique.

Zobozdravstvo - Slovar za sisteme dentalnih vsadkov (implantatov) in z njimi povezane postopke (ISO 16443:2014)

Standard EN ISO 16443 določa izraze in definicije za dentalne vsadke ter instrumente, pripomočke in najbolj pogosto uporabljene klinične izraze, povezane s sistemi dentalnih vsadkov in postopkov v zobozdravstvu. Materiali za presaditev in membrane niso vključene v tem mednarodnem standardu. Naslednji pripomočki prav tako ne spadajo na področje uporabe tega mednarodnega standarda. Pripomoček, ki je posebej zasnovan tako, da se namesti v lobanjsko-obrazne kosti, skozi nje ali nanje, katerega osnovni namen je zagotoviti sidrišče za epitezo (za nadomestitev na primer ušesa, nosu in delov oči ter orbitalne regije): – vsadek epiteza; – lobanjsko-obrazni vsadek; – maksilofacialni vsadek. Pripomoček, ki je posebej zasnovan tako, da se namesti v lobanjsko-obrazne kosti, skozi nje ali nanje, katerega osnovni namen je zagotoviti sidrišče za ortodontski pripomoček. – ortodontski vsadek.

General Information

• Status: Published
• Publication Date: 15-Jul-2014
• Withdrawal Date: 30-Jan-2015
• ICS: 01.020 - Terminology (principles and coordination)
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Jul-2014
• Due Date: 03-Apr-2015
• Completion Date: 16-Jul-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 16443:2014 - Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2014
Zobozdravstvo - Slovar za sisteme dentalnih vsadkov (implantatov) in z njimi
povezane postopke (ISO 16443:2014)
Dentistry - Vocabulary for dental implants systems and related procedure (ISO
16443:2014)
Zahnheilkunde- Vokabular der oralen Implantologie (ISO 16443:2014)
Médecine bucco-dentaire - Vocabulaire des systèmes d'implants dentaires et procédure
associée (ISO 16443:2014)
Ta slovenski standard je istoveten z: EN ISO 16443:2014
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 16443
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 01.020; 11.060.01
English Version
Dentistry - Vocabulary for dental implants systems and related
procedure (ISO 16443:2014)
Médecine bucco-dentaire - Vocabulaire des systèmes Zahnheilkunde- Vokabular der oralen Implantologie (ISO
d'implants dentaires et procédure associée (ISO 16443:2014)
16443:2014)
This European Standard was approved by CEN on 28 June 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16443:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 16443:2014) 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
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.
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 16443:2014 has been approved by CEN as EN ISO 16443:2014 without any modification.
INTERNATIONAL ISO
STANDARD 16443
NORME
First edition
Première édition
INTERNATIONALE 2014-07-15
Dentistry — Vocabulary for dental
implants systems and related
procedure
Médecine bucco-dentaire — Vocabulaire des systèmes d’implants
dentaires et procédures associées
Reference number
Numéro de référence
ISO 16443:2014(E/F)
©
ISO 2014
ISO 16443:2014(E/F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ISO 16443:2014(E/F)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions related on medical devices used in oral implantology .1
3.1 Dental implant . 1
3.2 Dental implant system . 2
3.3 Ancillary devices used in oral implantology. 6
4 Terms and definitions related to clinical and surgical concepts used in oral implantology .8
Bibliography .12
ISO 16443:2014(E/F)
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
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 3, Terminology.
ISO is now publishing all its standards using a processing system that allows the production of
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ISO 16443:2014(E/F)
Introduction
This terminology international standard has been prepared and is presented accordingly with
recommendations provided in
ISO 704, Terminology work — Principles and methods,
ISO 860, Terminology work — Harmonization of concepts and terms,
ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application, and
ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation.
Accordingly to ISO directives, ISO 704 and ISO 1087, this standard has been prepared and is presented
in a systematic approach. The systematic approach presents the advantage of being independent from
language, therefore allowing the same logical numbering in any language.
INTERNATIONAL STANDARD ISO 16443:2014(E/F)
Dentistry — Vocabulary for dental implants systems and
related procedure
1 Scope
This International Standard specifies terms and definitions for dental implants and for instruments,
accessories, and the most commonly used clinical terms related to implant systems and procedures in
dentistry. Grafting materials and membranes are excluded from this International Standard.
The following devices are also excluded from the scope of this International Standard.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears,
noses and parts of eyes and orbital regions):
— epithesis implant;
— craniofacial implant;
— maxillofacial implant.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an orthodontic appliance:
1)
— orthodontic implant .
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 — Vocabulary
NOTE Except for the following terminological entries that supersede ISO 1942:2009, the terms and definitions
given in ISO 1942 apply for the purpose of this document.
3 Terms and definitions related on medical devices used in oral implantology
For the purposes of this document, the following terms and definitions apply.
3.1 Dental implant
3.1.1
dental implant
device especially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purposes of which are to support and/or to resist displacement of a dental prosthesis
3.1.1.1
endosseous dental implant
endosteal implant (DEPRECATED)
dental implant (3.1.1) placed partially or entirely within the bone
1) This definition supersedes the one given in ISO 1942.
ISO 16443:2014(E/F)
3.1.1.2
interim endosseous dental implant
provisional implant
endosseous dental implant (3.1.1.1) for temporary usage
3.1.1.3
transendodontic implant
endodontic endosseous implant
transradicular implant (DEPRECATED)
rod, specially made to be inserted longitudinally either through a root canal or through a root segment
which extends through the apex into the surrounding bone to stabilize a tooth
3.1.1.4
intramucosal implant
oral mucosal insert
submucosal implant (DEPRECATED)
button implant (DEPRECATED)
dental implant (3.1.1) placed in the soft tissue lining of the oral cavity
3.1.1.5
ramus endosseous implant
ramus endosteal implant (DEPRECATED)
dental implant (3.1.1) placed within the ramus
...