SIST EN 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 für Dentalimplantate für die klinische Anwendung (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
• Public Enquiry End Date: 19-Aug-2012
• Publication Date: 20-Oct-2013
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Oct-2013
• Due Date: 06-Dec-2013
• Completion Date: 21-Oct-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 16498:2013 - Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)

Overview

EN ISO 16498:2013 / ISO 16498:2013 - "Dentistry - Minimal dental implant data set for clinical use" defines the minimal data set that must be recorded when a patient receives dental implant treatment. The standard ensures consistent recording of critical information about dental implant bodies, connecting components, adjunctive devices (including grafting materials) and suprastructures so that clinicians, dental laboratories, manufacturers and other stakeholders can reliably identify and manage implants over the lifetime of treatment.

Keywords: dental implant, minimal data set, ISO 16498:2013, implant records, dentistry standard.

Key Topics and Requirements

The standard lists the minimum clinical information to be captured in the patient file. Key requirements include:

• Patient and clinician identification

  • Patient name and date of birth
  • Clinician name and national registration/license number

• Implant bodies

  • Manufacturer, commercial name and unique part number (for pre-manufactured implants)
  • Material, implant type and dimensions
  • Batch code, lot number and/or serial number
  • Implantation date recorded using ISO 8601 date format
  • Location of placement using ISO 3950 tooth/area designation
  • Operation protocol details (e.g., insertion torque)
  • For patient-specific implants: record unique modifications, dimensions if known, coating details and minimum data to fabricate connecting components

• Connecting components

  • Date and responsible clinician
  • Commercial name, manufacturer, part number and lot/serial number (for prefabricated components)
  • Type of connection and mechanisms (e.g., screw fixation, taper fit, cementation)
  • Screw head configuration and screw material/composition
  • For patient-specific components: laboratory/manufacturer details and unique construction data

• Adjunctive devices and grafting materials

  • Manufacturer/agent, lot/serial number, quantity and placement date/location
  • For autografts: source and placement date

• Suprastructure (prosthesis)

  • Manufacturer/laboratory, materials and lot numbers, type/design, manufacturing and placement dates

Applications and Who Uses It

EN ISO 16498:2013 is intended for practical clinical use and secondary purposes:

• Dental clinicians and implant surgeons - ensure complete, standardized implant records for patient care and follow-up.
• Dental laboratories and manufacturers - identify components, support fabrication of restorative parts and ensure traceability.
• Clinical record systems / EHR vendors - implement structured fields to support interoperable implant data capture.
• Regulatory, medico-legal and forensic professionals - assist in identification, adverse event investigation and long-term documentation.
• Researchers and quality managers - use standardized datasets for studies, audits and device surveillance.

Related Standards

• ISO 1942 - Dentistry vocabulary (terms and definitions)
• ISO 3950 - Designation system for teeth and oral areas (implant location)
• ISO 8601 - Date/time representation
• Additional references: ISO 3166-1, ISO/TR 13668, ISO 16059, ISO/TR 15599 (codification, digital records)

This standard supports traceability, patient safety and long-term management of dental implants by providing a concise, practical template for recording essential implant information.

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
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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
...