EN ISO 13116:2014
(Main)Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014)
Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014)
ISO 13116:2014 specifies test methods for determination of radio-opacity of a test material by reference to a specimen of an aluminium standard. The method is designed to discriminate radio-opacity at a clinically meaningful level and is not designed to take account of factors which may affect precise, inherent values of radio-opacity such as background noise, X-ray beam power, grey scale correction and image enhancement. It is recognized that such factors can change the value of radio-opacity but not the relative ranking compared to standard thicknesses of an internal standard such as aluminium. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus.
Zahnheilkunde - Prüfverfahren zur Bestimmung der Röntgensichtbarkeit von Materialien (ISO 13116:2014)
Diese Internationale Norm legt ein Prüfverfahren zur Bestimmung der Röntgensichtbarkeit eines Prüfmaterials durch Vergleich mit einem Prüfkörper aus einem Aluminiumstandard fest. Diese Prüfung wurde entworfen um Röntgensichtbarkeiten bei einem klinisch relevanten Wert unterscheiden zu können und ist nicht dafür vorgesehen Faktoren, die die genauen inhärenten Werte der Röntgensichtbarkeit betreffen wie Hintergrundrauschen, Leistung des Röntgenstrahls, Grauwertkorrektur und Bildverstärkung zu berücksichtigen. Es wird anerkannt, dass solche Faktoren den Wert der Röntgensichtbarkeit ändern können, aber nicht das relative Ranking im Vergleich mit der Standarddicke eines internen Standards wie Aluminium. Diese Prüfung kann mit konventionellen oder digitalen Sensortechniken von dentalen Röntgengeräten durchgeführt werden.
Médecine bucco-dentaire - Méthodes de détermination de la radio opacité des matériaux (ISO 13116:2014)
L'ISO 13116:2014 spécifie des méthodes d'essai permettant de déterminer la radio-opacité d'un matériau testé par référence à une échelle de référence en aluminium. La méthode est conçue pour déterminer la radio-opacité à un niveau cliniquement significatif sans tenir compte des facteurs susceptibles d'influer sur la précision des valeurs de radio-opacité (bruit de fond, énergie du faisceau de rayons X, correction de l'échelle de gris, contraste de l'image).
Zobozdravstvo - Preskusna metoda za ugotavljanje sevalne prepustnosti materialov (ISO 13116:2014)
Ta mednarodni standard opredeljuje preskusno metodo za upogibno trdnost endodontskih zatičkov z nazidki. Pri tem preskusu se trdnost kombinacije zatičkov z nazidki, polnila škrbine in pritrditvenega materiala preskuša z linearno obremenitvijo. Preskusna metoda ni namenjena parapulpalnim zatičem.
General Information
- Status
- Published
- Publication Date
- 11-Nov-2014
- Withdrawal Date
- 30-May-2015
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 12-Nov-2014
- Due Date
- 03-Jan-2016
- Completion Date
- 12-Nov-2014
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
Overview
EN ISO 13116:2014 is an international standard that specifies the test method for determining the radio-opacity of dental materials. Developed by ISO/TC 106 Dentistry in collaboration with CEN/TC 55, this standard establishes procedures for evaluating the radio-opacity of test specimens by reference to an aluminium step wedge. The method enables dentists, manufacturers, and researchers to discriminate radio-opacity at clinically meaningful levels. It supports the use of both conventional and digital X-ray sensoring techniques, ensuring wide applicability in dental diagnostics and material testing.
Key Topics
Radio-opacity Measurement
The standard provides a clear, reproducible test approach to measure the radio-opacity of dental materials. It compares test specimens to a calibrated aluminium step wedge, which has thicknesses corresponding to typical levels of clinical relevance.Test Specimen Preparation
Samples are prepared using moulds to ensure uniform thickness-typically ranging from 0.5 mm to 2.5 mm, depending on the material type. Thickness measurements must be precise within 0.01 mm for accurate results.Use of Aluminium Step Wedge
The aluminium step wedge is crucial as a reference internal standard. It consists of equally spaced increments between 0.5 mm and 5.0 mm in thickness, with aluminium purity of at least 98%. This wedge simulates comparison standards against which dental materials’ radio-opacity is gauged.Apparatus and Equipment
- Dental X-ray unit operating at 60 ± 10 kV with 1.5 to 2 mm aluminium filtration
- Analogue X-ray films (speed group D, E, or F) or digital sensors (intra-oral sensors or phosphor imaging plates)
- Densitometer for measuring optical density on analogue films or grayscale analysis software for digital images
Test Conditions and Procedures
EN ISO 13116:2014 details precise conditions such as target distance (300–400 mm), exposure times, and measurement techniques to standardize radio-opacity testing. Procedures cover both analogue and digital testing equipment ensuring compatibility with current dental radiography technologies.Limitations and Considerations
The method does not adjust for external factors such as background noise, X-ray beam power variations, grayscale correction, or image enhancement processes. It focuses on the relative ranking of radio-opacity against aluminium standards rather than the absolute inherent values.
Applications
Dental Material Quality Control
Manufacturers use this standardized test to confirm whether restorative materials like composites, sealants, cements, and ceramics possess adequate radio-opacity for clinical diagnosis.Regulatory Compliance
Compliance with EN ISO 13116:2014 supports conformity with regional and international dental product regulations by providing validated methods to report radio-opacity values.Clinical Diagnostics
Radio-opacity is essential for distinguishing restorative materials from tooth structures and detecting secondary caries or marginal defects through X-rays. Materials tested per this standard enhance diagnostic accuracy.Research and Development
Researchers developing new dental materials utilize this standard to benchmark radio-opacity performance and optimize formulations for enhanced radiographic visibility.
Related Standards
- ISO 3665: Specifications for intra-oral dental radiographic films and film packets, ensuring use of appropriate analogue films in testing.
- ISO 1942: Dentistry vocabulary, providing consistent terminology relevant to dental materials and radio-opacity tests.
- ISO 8601: Data interchange formats, supporting standardized recording of test dates and times.
EN ISO 13116:2014 forms part of a broader framework ensuring quality and consistency in dental material evaluation, facilitating safe and effective use of dental restoratives across global markets.
Keywords: EN ISO 13116:2014, dentistry standard, radio-opacity test, dental materials, aluminium step wedge, dental X-ray test, dental material quality, analogue and digital radiography, dental restorative materials, dental material standards, dental X-ray sensor, dental radiology testing.
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Frequently Asked Questions
EN ISO 13116:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014)". This standard covers: ISO 13116:2014 specifies test methods for determination of radio-opacity of a test material by reference to a specimen of an aluminium standard. The method is designed to discriminate radio-opacity at a clinically meaningful level and is not designed to take account of factors which may affect precise, inherent values of radio-opacity such as background noise, X-ray beam power, grey scale correction and image enhancement. It is recognized that such factors can change the value of radio-opacity but not the relative ranking compared to standard thicknesses of an internal standard such as aluminium. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus.
ISO 13116:2014 specifies test methods for determination of radio-opacity of a test material by reference to a specimen of an aluminium standard. The method is designed to discriminate radio-opacity at a clinically meaningful level and is not designed to take account of factors which may affect precise, inherent values of radio-opacity such as background noise, X-ray beam power, grey scale correction and image enhancement. It is recognized that such factors can change the value of radio-opacity but not the relative ranking compared to standard thicknesses of an internal standard such as aluminium. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus.
EN ISO 13116:2014 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 13116:2014 has the following relationships with other standards: It is inter standard links to ISO 3665:2011, ISO 1942:2009, EN 1090-5:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13116:2014 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.
EN ISO 13116:2014 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-marec-2015
Zobozdravstvo - Preskusna metoda za ugotavljanje sevalne prepustnosti
materialov (ISO 13116:2014)
Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014)
Zahnheilkunde - Prüfverfahren zur Bestimmung der Röntgensichtbarkeit von Materialien
(ISO 13116:2014)
Médecine bucco-dentaire - Méthodes de détermination de la radio opacité des matériels
(ISO 13116:2014)
Ta slovenski standard je istoveten z: EN ISO 13116:2014
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 13116
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 11.060.10
English Version
Dentistry - Test Method for Determining Radio-Opacity of
Materials (ISO 13116:2014)
Médecine bucco-dentaire - Méthodes de détermination de Zahnheilkunde - Prüfverfahren zur Bestimmung der
la radio opacité des matériaux (ISO 13116:2014) Röntgensichtbarkeit von Materialien (ISO 13116:2014)
This European Standard was approved by CEN on 6 September 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 13116:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 13116:2014) 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 May 2015, and conflicting national standards shall be withdrawn at the
latest by May 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 13116:2014 has been approved by CEN as EN ISO 13116:2014 without any modification.
INTERNATIONAL ISO
STANDARD 13116
First edition
2014-11-01
Dentistry — Test Method for
Determining Radio-Opacity of Materials
Médecine bucco-dentaire — Méthodes de détermination de la radio
opacité des matériaux
Reference number
ISO 13116:2014(E)
©
ISO 2014
ISO 13116:2014(E)
© 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
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ii © ISO 2014 – All rights reserved
ISO 13116:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
5 Sampling . 1
6 Apparatus . 2
6.1 Suitable moulds for constructing samples of the test-material . 2
6.2 Screw micrometer gauge, or equivalent device . 2
6.3 Aluminium step wedge . 2
6.4 Dental X-ray unit . 2
6.5 Dental X-ray sensor . 2
7 Test conditions and procedures . 3
7.1 Test conditions . 3
7.2 Preparation of test specimens . 3
7.3 Test procedure for analogue equipment . 3
7.4 Test procedure for digital equipment. 3
8 Treatment of results . 4
ISO 13116:2014(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
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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 (see 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 (see 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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