SIST EN ISO 17254:2016/A1:2021

Dentistry - Coiled springs for use in orthodontics - Amendment 1 (ISO 17254:2016/Amd 1:2020)

2020-11-12 - TC decision is missing to skip FV.

Zahnheilkunde - Spiralfedern für die Kieferorthopädie - ÄNDERUNG 1 (ISO 17254:2016/Amd 1:2020)

No scope available

Médecine bucco-dentaire - Ressorts hélicoïdaux à usage orthodontique - Amendement 1 (ISO 17254:2016/Amd 1:2020)

Zobozdravstvo - Spiralne vzmeti za uporabo v ortodontiji - Dopolnilo A1 (ISO 17254:2016/Amd 1:2020)

General Information

• Status: Published
• Public Enquiry End Date: 19-May-2020
• Publication Date: 03-Jun-2021
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 12-May-2021
• Due Date: 17-Jul-2021
• Completion Date: 04-Jun-2021
• Ref Project: EN ISO 17254:2016/A1:2021 - Dentistry - Coiled springs for use in orthodontics - Amendment 1 (ISO 17254:2016/Amd 1:2020)

Relations

• Amends: SIST EN ISO 17254:2016 - Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
• Effective Date: 01-Jul-2021

Overview

EN ISO 17254:2016/A1:2021 is the CEN-adopted amendment to ISO 17254:2016 covering coiled springs for use in orthodontics. Approved by CEN on 12 December 2020 and published in the EN form in April 2021 (Slovenian adoption 01 Jul 2021), this amendment clarifies testing and conformity requirements for orthodontic coiled springs used as dental materials (ICS 11.060.10). It was prepared by ISO/TC 106 in collaboration with CEN/TC 55.

Key topics and technical requirements

• Scope: Applies to coiled springs intended for orthodontic use and their type testing as dental materials.
• Type tests: Clause 5.1 was updated to state explicitly that all tests in the document are type tests, and these shall be performed on representative samples of the item being tested.
• Force–displacement testing: Clause 5.3.2.4 now instructs testers to determine the mechanical behaviour of springs during unloading of the force–displacement test (i.e., behaviour when force is reduced after loading).
• Conformity criteria: Clause 5.4 clarifies that test results for each specimen must lie within the manufacturer’s specified range (referenced in clauses 6.1 b) and 6.1 d)) for the material to comply with the standard.
• Normative status: The amendment was endorsed by CEN without modification and exists in English, French and German official versions. Note: the document flags possible patent rights associated with elements of the standard.

Applications and who uses this standard

This standard is directly relevant to:

• Manufacturers of orthodontic coiled springs - for product design validation, quality control and production acceptance testing.
• Dental product testing laboratories - to perform type tests and produce test reports consistent with ISO/CEN requirements.
• Orthodontists and procurement specialists - to specify compliant springs and understand performance claims.
• Regulatory and quality managers in dental device companies - to demonstrate conformity and prepare technical documentation.
• R&D teams developing new spring materials or geometries - for comparative mechanical behaviour during unloading and force–displacement profiling.

Related standards and practical notes

• Related ISO and EN standards on dental materials and device testing may be relevant for complementary requirements (consult national standards bodies or the CEN-CENELEC Management Centre for bibliographic references).
• For full compliance and detailed test procedures, refer to the full text of ISO 17254:2016 and ISO 17254:2016/Amd 1:2020 (EN ISO 17254:2016/A1:2021) and the manufacturer’s specified ranges cited in clauses 6.1 b) and 6.1 d).

Keywords: orthodontic coiled springs, ISO 17254, EN ISO 17254:2016/A1:2021, force–displacement test, type tests, dental materials, orthodontic springs testing, CEN.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Zobozdravstvo - Spiralne vzmeti za uporabo v ortodontiji - Dopolnilo A1 (ISO
17254:2016/Amd 1:2020)
Dentistry - Coiled springs for use in orthodontics - Amendment 1 (ISO 17254:2016/Amd
1:2020)
Zahnheilkunde - Spiralfedern für die Kieferorthopädie - ÄNDERUNG 1 (ISO
17254:2016/Amd 1:2020)
Médecine bucco-dentaire - Ressorts hélicoïdaux à usage orthodontique - Amendement 1
(ISO 17254:2016/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 17254:2016/A1:2021
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 17254:2016/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Coiled springs for use in orthodontics -
Amendment 1 (ISO 17254:2016/Amd 1:2020)
Médecine bucco-dentaire - Ressorts hélicoïdaux à Zahnheilkunde - Spiralfedern für die Kieferorthopädie -
usage orthodontique - Amendement 1 (ISO ÄNDERUNG 1 (ISO 17254:2016/Amd 1:2020)
17254:2016/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 17254:2016; it was approved by CEN on 12 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17254:2016/A1:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 17254:2016/A1:2021) 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 17254:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2021,
and conflicting national standards shall be withdrawn at the latest by October 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 17254:2016/Amd 1:2020 has been approved by CEN as EN ISO 17254:2016/A1:2021
without any modification.
...