EN ISO 16443:2014
(Main)Dentistry - Vocabulary for dental implants systems and related procedure (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
Overview
EN ISO 16443:2014 / ISO 16443:2014 - "Dentistry - Vocabulary for dental implant systems and related procedure" is an international terminology standard published by ISO and adopted by CEN. It defines standardized terms and definitions for dental implants, implant components, instruments, accessories and commonly used clinical and surgical concepts in oral implantology. The standard excludes grafting materials and membranes and excludes epithesis, craniofacial, maxillofacial and orthodontic implants from its scope.
Key topics
This vocabulary standard organizes and harmonizes core terminology used across the dental implant industry. Key topics covered include:
- Dental implant and subtypes (e.g., endosseous, intramucosal, zygoma implant)
- Dental implant system and related concepts (implant kit, implant component, implant assembly)
- Implant body, implant body endosseous zone and tissue interface surface
- Connecting interface, including platform-switching design and anti-rotation features (internal/external)
- Implant abutments (straight, angulated, castable, CAD/CAM, ball/magnetic attachments) and implant connecting parts
- Transmucosal components, surface treatments and coatings
- Terminology for clinical and surgical concepts used in implant procedures
- Normative references and alignment with ISO terminology principles (ISO 1942, ISO 704, ISO 1087-1, ISO 860 and ISO 10241-1)
Note: EN ISO 16443:2014 is a terminology standard - it provides definitions and naming conventions rather than performance or testing requirements.
Applications
EN ISO 16443:2014 is practical for anyone who needs consistent, international dental implant terminology:
- Dental clinicians and surgeons - for clear communication in clinical records and referrals
- Manufacturers and product designers - to standardize product descriptions, labels and instructions for use (IFU)
- Regulatory and quality teams - to align documentation for conformity assessment and submissions
- Dental laboratories and CAD/CAM technicians - to ensure consistent component specification and ordering
- Educators, researchers and translators - for teaching, publications and multilingual consistency
- Procurement and supply chain - for unambiguous product cataloguing and contracts
Related standards
- ISO 1942 - Dentistry - Vocabulary (general dental terms)
- ISO terminology works referenced in the standard: ISO 704, ISO 860, ISO 1087‑1, ISO 10241‑1
- EN adoption: EN ISO 16443:2014 (CEN endorsement)
Using EN ISO 16443:2014 helps reduce ambiguity, improve technical communication, and support regulatory compliance across the dental implant ecosystem. Keywords: ISO 16443:2014, dental implants, implant systems, implant vocabulary, implant components, implant abutment, platform switching.
Frequently Asked Questions
EN ISO 16443:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)". This standard covers: 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.
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.
EN ISO 16443:2014 is classified under the following ICS (International Classification for Standards) categories: 01.020 - Terminology (principles and coordination); 01.040.11 - Health care technology (Vocabularies); 11.060.01 - Dentistry in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 16443:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 16443:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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
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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
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
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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
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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
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iv © ISO 2014 – All rights reserved/Tous droits réservés
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 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
SIST EN ISO 16443
...
記事タイトル: EN ISO 16443:2014 - 歯科 - 歯科インプラントシステムおよび関連手術のための用語集（ISO 16443:2014） 記事内容: ISO 16443:2014は、歯科インプラントおよびインプラントシステムおよび手術に関連する器具、アクセサリー、および最も一般的に使用される臨床用語の用語と定義を指定します。移植材料と膜はISO 16443:2014から除外されます。 以下のデバイスもISO 16443:2014の範囲から除外されています。 頭蓋顔面複合体の骨の内部、通過または上に設置されるように特別に設計されたデバイスで、主な目的は上皮を置き換えるために固定を提供することです（例えば、耳、鼻、目の一部、眼窩領域を置き換えるため）: - 上皮植え入れ; - 頭蓋顔面インプラント; - 口腔顔面インプラント. 頭蓋顔面複合体の骨の内側、通過または上に配置され、主な目的は矯正器具のための固定を提供することです: - 矯正インプラント.
記事タイトル：EN ISO 16443:2014 - 歯科 - 歯科インプラントシステムおよび関連手順のための用語集（ISO 16443:2014） 記事内容：ISO 16443:2014は、歯科インプラントや器具、アクセサリー、および歯科のインプラントシステムと手順に関連する一般的に使用される用語と定義を明示しています。移植材や膜はISO 16443:2014から除外されます。 以下のデバイスもISO 16443:2014の範囲外となります。 顔面骨に配置されるか、貼り付けられるか、またはその上に設置され、主な目的はエピテーゼ（例えば耳、鼻、眼および眼窩領域の一部の代替）の固定を提供するために特別に設計されたデバイスです： エピテーゼインプラント； 顔面インプラント； 口腔顎面インプラント。 顔面骨に配置されるか、貼り付けられるか、またはその上に設置され、主な目的は矯正装置の固定を提供するために特別に設計されたデバイスです： 矯正インプラント。
기사 제목: EN ISO 16443: 2014-치과-치과 임플란트 시스템 및 관련 절차에 대한 어휘 (ISO 16443: 2014) 기사 내용: ISO 16443:2014는 치과 임플란트와 관련된 기기, 액세서리 및 임플란트 시스템과 절차에 가장 일반적으로 사용되는 임상 용어에 대한 용어와 정의를 명시합니다. 이로 인해 이송 물질과 막은 ISO 16443:2014에서 제외됩니다. 다음 기기들도 ISO 16443: 2014의 적용 범위에서 제외됩니다. 두개안락원, 코, 눈과 뜬구비를 대체하는 에피태너을 위한 기기로 설계된 기기 : 에피태너 임플란트; 비골이식 임플란트; 악안면 임플란트. 치과교정기를 위해 두개안락원, 코, 눈과 뜬구비의 뼈 내부, 통과 또는 위에 설치되도록 특별히 설계된 기기 : 치과 교정 임플란트.
ISO 16443:2014 is a standard that provides terms and definitions related to dental implants and procedures in dentistry. It includes terms for implants, instruments, accessories, and clinical terminology. However, it excludes grafting materials, membranes, and specific devices that are designed for cranio-facial complex anchorage for epitheses, orthodontic appliances, craniofacial, and maxillofacial implants.
The article introduces the EN ISO 16443:2014 standard, which provides definitions and terms related to dental implants, instruments, accessories, and procedures in dentistry. The standard excludes grafting materials and membranes. Additionally, it specifies that certain devices designed for cranio-facial complex anchorage, such as epithesis implants, craniofacial implants, and maxillofacial implants, as well as orthodontic implants, are also outside the scope of ISO 16443:2014.
기사 제목: EN ISO 16443:2014 - 치과 - 치주이식체 시스템 및 관련 절차에 대한 어휘 (ISO 16443:2014) 기사 내용: ISO 16443:2014는 치과 임플란트와 장비, 악세서리 및 치과 임플란트 시스템 및 절차와 관련된 가장 일반적으로 사용되는 임상 용어에 대한 용어와 정의를 규정합니다. 이에는 이식 재료 및 막이 제외됩니다. 다음 장치들은 ISO 16443:2014의 범위에서도 제외됩니다. 뼈에 안착을 위해 특별히 설계된 장치로서 크라니오-안면 복합체의 뼈 안, 통과 또는 위에 배치되는 주된 목적은 상체를 고정시키기 위함인 것을 교체하기 위한 에피테시스에 대한: 에피테시스 임플란트; 크라니오안면 임플란트; 턱악안면 임플란트. 치습을 위한 주된 목적으로 크라니오-안면 복합체의 뼈 안, 통과 또는 위에 배치되는 특별히 설계된 장치: 치습용 임플란트.
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