SIST EN ISO 15841:2014/A1:2021
(Amendment)Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)
Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)
Zahnheilkunde - Drähte für die Kieferorthopädie - Änderung 1 (ISO 15841:2014/Amd 1:2020)
No scope available
Médecine bucco-dentaire - Fils pour utilisation en orthodontie - Amendement 1 (ISO 15841:2014/Amd 1:2020)
Zobozdravstvo - Žice za uporabo v ortodontiji - Dopolnilo A1 (ISO 15841:2014/Amd 1:2020)
General Information
- Status
- Published
- Public Enquiry End Date
- 19-May-2020
- Publication Date
- 20-Jan-2021
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 07-Jan-2021
- Due Date
- 14-Mar-2021
- Completion Date
- 21-Jan-2021
Relations
- Effective Date
- 01-Feb-2021
Overview
SIST EN ISO 15841:2014/A1:2021 is an important amendment to the international standard governing wires used in orthodontics. Published by CEN in December 2020, this document updates the specifications and testing protocols originally set out in ISO 15841:2014. The amendment, known as Amendment 1, aims to enhance the quality assurance processes around orthodontic wires, which are critical components in dental treatment for correcting teeth alignment.
This European Standard aligns with the global ISO framework to provide dental professionals and manufacturers with clear guidelines on the properties and testing requirements of orthodontic wires, ensuring safety, reliability, and performance consistency in clinical applications.
Key Topics
Scope and Purpose
The amendment modifies EN ISO 15841:2014 to refine test procedures and compliance criteria for orthodontic wires used in dental treatments.Testing Updates
All testing is categorized as type testing, meaning tests must be conducted on representative samples of the wires to verify conformity before production.Treatment of Results
A new clause requires that test results fall within the manufacturer's specified ranges for mechanical and physical properties, ensuring materials meet defined quality standards.Quality Compliance
This amendment formalizes the importance of adhering to specified parameters for tensile strength, dimensional consistency, and other critical material characteristics.Harmonization
SIST EN ISO 15841:2014/A1:2021 is designed to be implemented nationally across EU member countries without alteration, promoting uniformity in orthodontic wire standards throughout Europe.
Applications
Orthodontic Treatment
The standard is essential for manufacturers producing orthodontic wires used in braces and other dental appliances aimed at correcting malocclusions and aligning teeth.Quality Control in Manufacturing
Wire manufacturers utilize this standard to guide material selection, testing procedures, and quality assurance to achieve compliance and clinical safety.Dental Laboratories and Clinics
Adoption of the standard helps dental professionals ensure that the orthodontic wires they use meet internationally recognized performance benchmarks, improving treatment outcomes.Research and Development
Developers of new orthodontic wire materials and technologies reference this amendment to validate innovations against established testing and property criteria.
Related Standards
- ISO 27020 – Orthodontic Devices – General Requirements and Test Methods
- EN ISO 10993 – Biological Evaluation of Medical Devices
- ISO 13485 – Quality Management Systems for Medical Devices
- EN ISO 1942 – Medical Devices – Vocabulary
These standards complement SIST EN ISO 15841:2014/A1:2021 by covering broader aspects of dental materials, medical device safety, and quality processes, contributing to a comprehensive regulatory framework for orthodontic product manufacturing and usage.
Keywords: orthodontic wires, EN ISO 15841, Amendment 1, dental materials standard, orthodontics, wire testing, quality assurance, dental wire manufacturing, orthodontic treatment, CEN standard.
Frequently Asked Questions
SIST EN ISO 15841:2014/A1:2021 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)". This standard covers: No scope available
No scope available
SIST EN ISO 15841:2014/A1:2021 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.
SIST EN ISO 15841:2014/A1:2021 has the following relationships with other standards: It is inter standard links to SIST EN ISO 15841:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 15841:2014/A1:2021 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-februar-2021
Zobozdravstvo - Žice za uporabo v ortodontiji - Dopolnilo A1 (ISO 15841:2014/Amd
1:2020)
Dentistry - Wires for use in orthodontics - Amendment 1 (ISO 15841:2014/Amd 1:2020)
Zahnheilkunde - Drähte für die Kieferorthopädie - Änderung 1 (ISO 15841:2014/Amd
1:2020)
Médecine bucco-dentaire - Fils pour utilisation en orthodontie - Amendement 1 (ISO
15841:2014/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 15841:2014/A1:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15841:2014/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2020
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Wires for use in orthodontics - Amendment 1
(ISO 15841:2014/Amd 1:2020)
Médecine bucco-dentaire - Fils pour utilisation en Zahnheilkunde - Drähte für die Kieferorthopädie -
orthodontie - Amendement 1 (ISO 15841:2014/Amd Änderung 1 (ISO 15841:2014/Amd 1:2020)
1:2020)
This amendment A1 modifies the European Standard EN ISO 15841:2014; it was approved by CEN on 13 December 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15841:2014/A1:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15841:2014/A1:2020) 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 Amendment to the European Standard EN ISO 15841:2014 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2021, and
conflicting national standards shall be withdrawn at the latest by June 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15841:2014/Amd 1:2020 has been approved by CEN as EN ISO 15841:2014/A1:2020
...
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