EN ISO 17254:2016
(Main)Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
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.
Zahnheilkunde - Spiralfedern für die Kieferorthopädie (ISO 17254:2016)
Médecine bucco-dentaire - Ressorts hélicoïdaux à usage orthodontique (ISO 17254:2016)
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.
Zobozdravstvo - Spiralne vzmeti za uporabo v ortodontiji (ISO 17254:2016)
Ta mednarodni standard se uporablja za vzmeti za uporabo v fiksnih ortodontskih napravah. Ta mednarodni standard podaja podrobne metode za primerjavo funkcionalnih mer ortodontskih vzmeti, preskusne metode, s katerimi se določajo, ter informacije o embalaži in označevanju.
General Information
Relations
Overview
EN ISO 17254:2016 (ISO 17254:2016) - "Dentistry - Coiled springs for use in orthodontics" - specifies how to characterize, test, package and label coiled springs used in orthodontic appliances. Adopted by CEN as a European Standard, it provides standardized test methods and declaration requirements so clinicians and manufacturers can compare physical and mechanical properties of orthodontic springs reliably.
Key topics and requirements
- Scope: Applies to coiled springs for orthodontic use and sets methods to compare physical and mechanical properties, plus packaging and labelling requirements.
- Declared properties: Manufacturers must declare dimensions, chemical composition and mechanical behaviour; declared values must match test results.
- Critical dimensions: inner diameter (di), outer diameter (do), unloaded spring length (luc / lue) and total length (lt). Dimensions are reported to 0.01 mm.
- Sampling and measurement: Six specimens per batch; measurements with calipers, micrometers or optical comparators accurate to 0.005 mm; record to 0.01 mm.
- Mechanical properties: Measure elastic behaviour during unloading:
- maximum extension (εmax)
- maximum compression (cmax)
- spring loads at 80%, 60%, 40% and 20% of maximum extension/compression
- Test equipment & conditions: Mechanical testing machine calibrated for force and displacement; crosshead rate 0.5–10.0 mm/min; tests at (23 ± 2) °C (or (36 ± 1) °C for temperature-sensitive springs); specimen length (20 ± 0.2) mm or unloaded spring length if less.
- Hazardous elements: Manufacturers must state mass fractions (%) of cadmium, beryllium, lead and nickel. All alloy elements ≥0.1% by mass must be declared.
- Packaging & labelling: Packaging must protect against contamination; labelling/catalogue/insert must include composition, dimension ranges, spring design (compression/extension) and mechanical property ranges.
Practical applications and users
- Who uses it: Spring manufacturers, dental product suppliers, orthodontic laboratories, clinicians, procurement teams, conformity assessors and regulatory authorities.
- Why it’s useful: Enables consistent specification and comparison of orthodontic springs, supports quality control and regulatory compliance, and helps clinicians select springs with predictable mechanical behaviour for treatment planning.
- Benefits: Improves product interoperability, reduces variability in clinical performance, and provides clear labelling and packaging guidance for safe handling and storage.
Related standards
- ISO 1942 - Dentistry - Vocabulary (terms/definitions referenced)
- ISO 10993-1 and ISO 7405 - for biological/toxicological hazard assessment (referenced guidance)
Keywords: EN ISO 17254:2016, ISO 17254, coiled springs, orthodontics, orthodontic springs, test methods, mechanical properties, dental materials, packaging and labelling.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2016
Zobozdravstvo - Spiralne vzmeti za uporabo v ortodontiji (ISO 17254:2016)
Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
Zahnheilkunde - Spiralfedern für die Kieferorthopädie (ISO 17254:2016)
Médecine bucco-dentaire - Ressorts hélicoïdaux à usage orthodontique (ISO
17254:2016)
Ta slovenski standard je istoveten z: EN ISO 17254:2016
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17254
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2016
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Coiled springs for use in orthodontics (ISO
17254:2016)
Médecine bucco-dentaire - Ressorts hélicoïdaux à Zahnheilkunde - Spiralfedern für die Kieferorthopädie
usage orthodontique (ISO 17254:2016) (ISO 17254:2016)
This European Standard was approved by CEN on 15 July 2016.
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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17254:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 17254:2016) 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 February 2017, and conflicting national standards
shall be withdrawn at the latest by February 2017.
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 17254:2016 has been approved by CEN as EN ISO 17254:2016 without any modification.
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 17254:2016(E)
©
ISO 2016
ISO 17254:2016(E)
© 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
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copyright@iso.org
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ii © ISO 2016 – All rights reserved
ISO 17254:2016(E)
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 .
...
Frequently Asked Questions
EN ISO 17254:2016 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)". 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.
EN 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.
EN ISO 17254:2016 has the following relationships with other standards: It is inter standard links to EN ISO 17254:2016/A1:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 17254:2016 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.
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