EN ISO 16498:2013
(Main)Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)
Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)
ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s).
Zahnheilkunde - Mindestdatensatz bei der klinischen Anwendung von Dentalimplantaten (ISO 16498:2013)
Diese Internationale Norm legt den Mindestdatensatz fest, der bei einem Patienten aufzuzeichnen ist, der mit
einem Dentalimplantat versorgt wird. Das umfasst die Lage und Typen der Dentalimplantatkörper,
Verbindungsteile und unterstützenden Medizinprodukte, einschließlich der Transplantatmaterialien, die in den
(die) Kiefer eines Patienten eingesetzt werden. Die endgültige Prothese ist nicht enthalten.
Diese Angaben werden vom verantwortlichen Arzt in der Patientenakte aufgezeichnet und sollten dem
Patienten von dem (den) behandelnden Arzt (Ärzten) zur Verfügung gestellt werden.
Médecine bucco-dentaire - Informations cliniques minimales requises pour les porteurs d'implants dentaires (ISO 16498:2013)
L'ISO 16498:2013 spécifie la série de données minimale à enregistrer pour un patient recevant un traitement implantaire. Ces données indiquent notamment le type et l'emplacement d'implantation des corps d'implant dentaire, éléments de connexion et dispositifs d'adjonction, y compris matériaux de greffe, posés dans la ou les mâchoires du patient.
Zobozdravstvo - Najmanjši skupek podatkov o dentalnih implantatih za klinično uporabo (ISO 16498:2013)
Ta mednarodni standard določa najmanjši skupek podatkov, ki se zabeležijo za bolnika, ki prejema dentalni implantat. To vključuje lokacije in tipe dentalnih implantatov, povezovalnih komponent in dopolnilnih naprav, vključno z materiali za presaditev, ki se vsadijo v bolnikovo čeljust. Te podatke beleži pristojni zdravnik v bolnikovi kartoteki in zdravnik, ki izvaja postopek, mora bolniku omogočiti dostop do njih.
General Information
- Status
- Published
- Publication Date
- 23-Jul-2013
- Withdrawal Date
- 30-Jan-2014
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 24-Jul-2013
- Completion Date
- 24-Jul-2013
- Directive
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 12-Feb-2026
Overview
EN ISO 16498:2013 (Dentistry - Minimal dental implant data set for clinical use) establishes the minimum requirements for recording essential clinical data when a patient receives dental implant treatment. Published by CEN, this standard focuses on ensuring that critical information about dental implants-including implant bodies, connecting components, adjunctive devices, and grafting materials-is properly documented and made available for ongoing patient care.
Implementation of EN ISO 16498:2013 improves the quality and safety of dental implant procedures by supporting consistent data capture across dental practices and clinics. Accurate and readily available implant records benefit clinical care, research, medico-legal documentation, and forensic investigations.
Key Topics
Minimal Data Set Requirements:
The standard defines the essential data elements to be recorded for all dental implant cases, which include:- Patient’s identification (name, date of birth)
- Clinician’s identification (name, national registration/license number)
- Details of implant bodies (manufacturer, type, material, size, batch/lot/serial number, placement date, location, and operation protocol)
- Information on connecting components (type, manufacturer, batch/lot/serial number, connection mechanism)
- Specification of adjunctive devices (e.g., grafting materials, source, quantity, placement date)
- Suprastructure and dental prosthesis information (manufacturer, type, design, materials, placement date)
Applicability:
The scope covers all types of dental implants and associated components-both pre-manufactured and patient-specific-and defines processes for both clinical documentation and patient communication.Standardized Recording:
Utilizes international coding systems, such as ISO 3950 for dental location notation and ISO 8601 for date formatting, ensuring uniformity and interoperability across information systems.Data Utility:
The documented data set supports not only routine clinical follow-up but also serves research, forensic, and legal needs.
Applications
Clinical Documentation:
Dental practitioners use EN ISO 16498:2013 to document essential details of implant treatments in patient records, improving care continuity and traceability.Patient Communication:
The recorded implant data should be made available to patients, facilitating future care and informed decision-making.Forensic and Legal Reference:
Standardized records can be critical in forensic investigations or medico-legal reviews, where accurate identification of dental implants is necessary.Quality Assurance and Research:
Researchers and quality managers leverage the minimal data set to analyze implant success, complication rates, and outcomes across different demographics or device types.Data Interoperability:
Dental software systems can utilize the standardized data format for effective data exchange and integration, aiding in digital health records management.
Related Standards
Organizations referencing EN ISO 16498:2013 often benefit from considering related international dental and information standards, which support robust data handling in dental implantology:
- ISO 1942: Dentistry – Vocabulary (provides definitions for dental terminology)
- ISO 3950: Dentistry – Designation system for teeth and areas of the oral cavity (used for specifying implant locations)
- ISO 8601: Data elements and interchange formats – Representation of dates and times (standard for recording dates)
- ISO 3166-1: Codes for the representation of names of countries and their subdivisions
- ISO/TR 13668: Digital coding of oral health and care
- ISO 16059: Dentistry – Required elements for codification used in data exchange
- ISO/TR 15599: Digital codification of dental laboratory procedures
EN ISO 16498:2013 supports harmonized and practical clinical data management in dental implantology, fostering improved patient outcomes and cross-border collaboration in dental care.
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Frequently Asked Questions
EN ISO 16498:2013 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)". This standard covers: ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s).
ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s).
EN ISO 16498:2013 is classified under the following ICS (International Classification for Standards) categories: 11.060.01 - Dentistry in general; 11.060.15 - Dental implants. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 16498:2013 has the following relationships with other standards: It is inter standard links to ISO 16498:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 16498:2013 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.
EN ISO 16498:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2013
=RER]GUDYVWYR1DMPDQMãLVNXSHNSRGDWNRYRGHQWDOQLKLPSODQWDWLK]DNOLQLþQR
XSRUDER,62
Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)
Zahnheilkunde - Mindestdatensatz für Dentalimplantate für die klinische Anwendung
(ISO 16498:2013)
Médecine bucco-dentaire - Informations cliniques minimales requises pour les porteurs
d'implants dentaires (ISO 16498:2013)
Ta slovenski standard je istoveten z: EN ISO 16498:2013
ICS:
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 16498
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2013
ICS 11.060.15
English Version
Dentistry - Minimal dental implant data set for clinical use (ISO
16498:2013)
Médecine bucco-dentaire - Informations cliniques Zahnheilkunde - Mindestdatensatz für Dentalimplantate für
minimales requises pour les porteurs d'implants dentaires die klinische Anwendung (ISO 16498:2013)
(ISO 16498:2013)
This European Standard was approved by CEN on 12 July 2013.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16498:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 16498:2013) 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 2014, and conflicting national standards shall be withdrawn at
the latest by January 2014.
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 16498:2013 has been approved by CEN as EN ISO 16498:2013 without any modification.
INTERNATIONAL ISO
STANDARD 16498
First edition
2013-07-15
Dentistry — Minimal dental implant
data set for clinical use
Médecine bucco-dentaire — Informations cliniques minimales
requises pour les porteurs d’implants dentaires
Reference number
ISO 16498:2013(E)
©
ISO 2013
ISO 16498:2013(E)
© ISO 2013
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.
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Published in Switzerland
ii © ISO 2013 – All rights reserved
ISO 16498:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General information . 1
4.1 Patient’s identification . 1
4.2 Clinician’s identification. 2
4.3 Implant bodies . 2
4.4 Connecting components . 2
4.5 Adjunctive devices . 3
4.6 Suprastructure . 3
Bibliography . 5
ISO 16498:2013(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.
The procedures used to develop this do
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