ISO 17254:2016
(Main)Dentistry — Coiled springs for use in orthodontics
Dentistry — Coiled springs for use in orthodontics
ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.
Médecine bucco-dentaire — Ressorts hélicoïdaux à usage orthodontique
L'ISO 17254 :2016 est applicable aux ressorts hélicoïdaux destinés à être utilisés dans des appareils orthodontiques. Elle spécifie les détails des méthodes permettant de comparer les caractéristiques physiques et mécaniques des ressorts hélicoïdaux, les méthodes d'essai permettant de déterminer ces caractéristiques, ainsi que les exigences relatives à l'emballage et à l'étiquetage.
General Information
- Status
- Published
- Publication Date
- 11-Jul-2016
- Technical Committee
- ISO/TC 106/SC 1 - Filling and restorative materials
- Drafting Committee
- ISO/TC 106/SC 1 - Filling and restorative materials
- Current Stage
- 9092 - International Standard to be revised
- Start Date
- 19-Sep-2023
- Completion Date
- 12-Feb-2026
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 06-Jun-2022
- Amended By
ISO 17254:2016/Amd 1:2020 - Dentistry — Coiled springs for use in orthodontics — Amendment 1 - Effective Date
- 04-Sep-2021
Overview
ISO 17254:2016 - Dentistry - Coiled springs for use in orthodontics specifies how to characterize, test, package and label coiled springs used in orthodontic appliances. The standard defines required product information that manufacturers must declare, the test methods to compare physical and mechanical properties, sampling rules, and packaging/labelling requirements intended to help clinicians and purchasers make informed comparisons between spring products.
Key topics and requirements
- Scope: Applies to coiled springs for orthodontic appliances and gives methods to compare their physical and mechanical behaviour.
- Declared properties: Manufacturers must declare dimensions, mechanical properties and chemical composition; test results shall be within the manufacturer’s declared ranges when tested per the standard.
- Dimensions:
- Manufacturers state inner diameter (id), outer diameter (od), unloaded length (lu) and total length (lt) to the nearest 0.01 mm.
- Measurement equipment accuracy: 0.005 mm (calipers, micrometers, optical comparators, etc.).
- Mechanical properties:
- Elastic behaviour during unloading: maximum extension (εmax), maximum compression (cmax).
- Spring loads on unloading after loading to the specified maximum at 80%, 60%, 40% and 20% of maximum extension/compression (L80%max, L60%max, L40%max, L20%max).
- Test apparatus: calibrated mechanical testing machine; crosshead rate 0.5–10.0 mm/min.
- Test temperature: 23 ± 2 °C, except temperature-sensitive springs tested at 36 ± 1 °C.
- Specimen length for testing: (20 ± 0.2) mm or the unloaded length if less than 20 mm.
- Sampling: Six specimens from a single batch for each test; each specimen measured for all declared dimensions and properties.
- Hazardous elements: Cadmium, beryllium and nickel are designated hazardous; manufacturers must state mass fractions when present > 0.1%.
- Packaging & labelling:
- Required information: manufacturer name/address, product/trade name, spring design, lot number, quantity, intended use and warnings for hazardous elements.
- Packaging must protect against contamination in transit and storage.
Applications and users
- Who uses it: orthodontic spring manufacturers and suppliers, test laboratories, quality managers, dental device regulators, dental laboratories, and clinicians who compare springs for clinical selection.
- Practical uses:
- Product specification and quality control for manufacturing and incoming inspection.
- Comparative evaluation of springs’ mechanical behaviour for clinical selection.
- Regulatory and procurement documentation (labelling, hazardous element disclosure).
- Test-lab protocols for standardized mechanical testing.
Related standards
- ISO 1942 - Dentistry vocabulary (terms and definitions referenced).
- ISO 10993-1 and ISO 7405 - referenced for biological/biocompatibility evaluation (recommended for assessing toxicological hazards).
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Frequently Asked Questions
ISO 17254:2016 is a standard published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Coiled springs for use in orthodontics". This standard covers: ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.
ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.
ISO 17254:2016 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.
ISO 17254:2016 has the following relationships with other standards: It is inter standard links to EN ISO 17254:2016, ISO 29001:2020, ISO 17254:2016/Amd 1:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 17254:2016 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)
INTERNATIONAL ISO
STANDARD 17254
First edition
2016-07-15
Dentistry — Coiled springs for use in
orthodontics
Médecine bucco-dentaire — Ressorts hélicoïdaux à usage
orthodontique
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General . 3
4.2 Dimensions . 3
4.3 Mechanical properties . 3
4.4 Hazardous elements . 3
5 Test methods . 3
5.1 Sampling . 3
5.2 Dimensions . 3
5.2.1 Apparatus . 3
5.2.2 Measurement procedures . 3
5.3 Mechanical properties . 4
5.3.1 Apparatus . 4
5.3.2 Measurement procedures . 4
5.4 Treatment of results . 4
6 Packaging and labelling information . 4
6.1 General requirements . 4
6.2 Packaging . 4
6.3 Labelling . 5
Bibliography . 6
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
constitute an endorsement.
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, Subc
...
NORME ISO
INTERNATIONALE 17254
Première édition
2016-07-15
Médecine bucco-dentaire — Ressorts
hélicoïdaux à usage orthodontique
Dentistry — Coiled springs for use in orthodontics
Numéro de référence
©
ISO 2016
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Exigences . 3
4.1 Généralités . 3
4.2 Dimensions . 3
4.3 Caractéristiques mécaniques . 3
4.4 Éléments dangereux . 3
5 Méthodes d’essai . 3
5.1 Échantillonnage . 3
5.2 Dimensions . 4
5.2.1 Appareillage . 4
5.2.2 Modes opératoires de mesure . 4
5.3 Caractéristiques mécaniques . 4
5.3.1 Appareillage . 4
5.3.2 Modes opératoires de mesure . 4
5.4 Traitement des résultats . 4
6 Informations relatives à l’emballage et à l’étiquetage . 4
6.1 Exigences générales . 4
6.2 Emballage . 5
6.3 Étiquetage . 5
Bibliographie . 6
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
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gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
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concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
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l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
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Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à
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de l’OMC concernant les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos —
Informations supplémentaires.
Le comité chargé de l’élaboration du présent document est l’ISO/TC 106, Médecine bucco-dentaire, Sous-
comité SC 1, Produits pour obturation et restauration.
iv © ISO 2016 – Tous droits réservés
Introduction
La présente Norme internationale a été élaborée en vue de spécifier les informations fournies par les
fabricants et les fournisseurs pour aider les cliniciens à comparer les ressorts hélicoïdaux.
Aucune méthode d’essai qualitative ou quantitative spécifique visant à démontrer l’absence de risques
biologiques inacceptables n’est incluse da
...
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