ISO 16443:2014
(Main)Dentistry — Vocabulary for dental implants systems and related procedure
Dentistry — Vocabulary for dental implants systems and related procedure
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.
Médecine bucco-dentaire — Vocabulaire des systèmes d'implants dentaires et procédures associées
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.
General Information
Standards Content (Sample)
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 2014
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
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.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland/Publié en Suisse
iiii © ISO 2014 – All rig© ISO 2014 – All rights rhts reserveserved/Ted/Tous drous droits roits réservéservésés
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
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. 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. 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 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
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.
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
3.2.3
dental implant assembly
assembly of dental implant components (3.2.2) as recommended by the manufacturer(s) to serve the
purposes of a dental implant (3.1.1)
3.2.4
implant body
dental implant body
implant fixture (DEPRECATED)
endosteal implant body (DEPRECATED)
primary single component or portion of a dental implant (3.1.1) which is intended to remain within the
hard and soft tissues and can be totally or partially submerged by soft tissue
3.2.4.1
implant body endosseous zone
portion of the implant body (3.2.4) which is intended for intra-bone positioning
3.2.5
transmucosal component
part of a dental implant system (3.2.1) that passes through the mucosa
3.2.6
tissue interface surface
implant contact surface
surface of an implant body (3.2.4) or implant component (3.2.2) intended to contact the patient’s tissues
3.2.7
tissue interface surface treatment
modification of a dental implant component (3.2.2) surface by subtraction or addition of material
3.2.7.1
implant component coating
implant component (3.2.2) surface treatment by addition
3.2.8
connecting interface
implant connective platform
portion of a dental implant body (3.2.4) or implant component (3.2.2) intended to connect with another
implant component (3.2.2)
3.2.8.1
platform switching design
connecting interface (3.2.8) designed to allow the use of implant abutments (3.2.10) with diameters less
than that of the implant body (3.2.4)
3.2.9
anti-rotation feature
design of the connecting interface (3.2.8), that prevents rotation of the connected implant component
(3.2.2) around the central long axis of the implant body (3.2.4)
3.2.9.1
external anti-rotation feature
anti-rotation feature (3.2.9) extending outside the implant body (3.2.4)
3.2.9.2
internal anti-rotation feature
anti-rotation feature (3.2.9) shaped within the implant body (3.2.4)
3.2.10
implant abutment
implant component (3.2.2) connected to the implant body (3.2.4) or implant connecting part (3.2.11),
which serves as an abutment
3.2.10.1
straight implant abutment
non-angulated implant abutment
non-angled implant abutment
implant abutment (3.2.10) having central long axis coincident with that of the implant body (3.2.4)
3.2.10.2
angulated implant abutment
angled abutment
implant abutment (3.2.10) having a principal long axis divergent from the central long axis of the implant
body (3.2.4)
3.2.10.3
castable implant abutment
castable abutment
prefabricated implant abutment (3.2.10) intended to be customized and used for casting
3.2.10.4
partially castable implant abutment
partially castable abutment
UCLA abutment (DEPRECATED)
prefabricated implant abutment (3.2.10) intended to be customized and cast except for the connecting
interface (3.2.8)
3.2.10.5
preparable abutment
milling abutment
implant abutment (3.2.10) intended to be customized in its shape or form by a milling process
3.2.10.6
CAD/CAM abutment
patient specific implant abutment (3.2.10) designed and fabricated using the CAD/CAM process
3.2.10.7
implant ball abutment
ball abutment
implant abutment that serves as a prosthetic attachment
3.2.10.8
implant magnetic abutment
magnetic abutment
implant abutment (3.2.10) that serves as a magnetic prosthetic attachment
3.2.11
implant connecting part
dental implant connecting part
implant component (3.2.2) used between the implant body (3.2.4) and the implant abutment (3.2.10)
3.2.12
monopart implant
monotype implant
one-piece implant
1-piece implant
endosseous dental implant
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.