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
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-Jul-2014
Completion Date
16-Jul-2014

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SLOVENSKI STANDARD
SIST EN ISO 16443:2014
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
SIST EN ISO 16443:2014 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16443:2014
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SIST EN ISO 16443:2014
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.
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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.
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SIST EN ISO 16443:2014
EN ISO 16443:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 16443:2014
EN ISO 16443:2014 (E)
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.

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SIST EN ISO 16443:2014
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SIST EN ISO 16443:2014
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
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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)
COPYRIGHT PROTECTED DOCUMENT
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014

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iiii © ISO 2014 – All rig© ISO 2014 – All rights rhts reserveserved/Ted/Tous drous droits roits réservéservésés

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SIST EN ISO 16443:2014
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 2014 – All rights reserved/Tous droits réservés iii
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SIST EN ISO 16443:2014
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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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. 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

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to Trade (TBT), see the following URL: Foreword - Supplementary information

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

International Standards as XML files. With this new system, the terms and definitions from terminologies

and vocabularies are stored in the Online Browsing Platform (OBP) (www.iso.org/obp) where they can

be browsed free of charge by members of the public (but not downloaded).
iv © ISO 2014 – All rights reserved/Tous droits réservés
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SIST EN ISO 16443:2014
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.
© ISO 2014 – All rights reserved/Tous droits réservés v
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SIST EN ISO 16443:2014
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SIST EN ISO 16443:2014
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:

— 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 2014 – All rights reserved/Tous droits réservés 1
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SIST EN ISO 16443:2014
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 of the mandible
3.1.1.6
frame implant
ramus frame endosteal implant (DEPRECATED)

One-piece implant consisting of a number of mandibular subperiosteal and/or endosseous components

linked with an intra-oral structure
3.1.1.7
subperiosteal dental implant
subperiosteal implant abutment (DEPRECATED)

dental implant (3.1.1) that is placed beneath the periosteum and overlying the bony cortex

3.1.1.8
transmandibular implant

dental implant (3.1.1) consisting of a plate and posts designed so that the posts can be placed to extend

vertically from the inferior border of the mandible through the plate, bone and mucosa and into the oral

cavity in the anterior region
3.1.1.9
zygoma implant

dental implant (3.1.1) intended to be partially inserted into or on the zygomatic bone

3.2 Dental implant system
3.2.1
dental implant system
implant kit
implant system

integrated system of components, specific equipment and ancillary instruments necessary for the

clinical and laboratory procedures required for the placement of the dental implant (3.1.1) and the

construction and insertion of an implant-supported dental prosthesis
3.2.2
implant component
element of a dental implant system (3.2.1)
2 © ISO 2014 – All rights reserved/Tous droits réservés
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SIST EN ISO 16443
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