SIST EN ISO 16498:2013

Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013)

This International Standard 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). This information will be recorded by the responsible clinician in the patient’s file and should be made available to the patient by the clinician(s) who provided the care.

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)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16498:2013
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
SIST EN ISO 16498:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16498:2013

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SIST EN ISO 16498:2013


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.

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SIST EN ISO 16498:2013
EN ISO 16498:2013 (E)
Contents Page
Foreword .3

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SIST EN ISO 16498:2013
EN ISO 16498:2013 (E)
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.

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SIST EN ISO 16498:2013

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SIST EN ISO 16498:2013
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

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SIST EN ISO 16498:2013
ISO 16498:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

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SIST EN ISO 16498:2013
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 2013 – All rights reserved iii

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SIST EN ISO 16498:2013
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
...