EN ISO 21606:2007/prA1
(Amendment)Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)
Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)
Zahnheilkunde - Elastomere Elemente für die Kieferorthopädie - ÄNDERUNG 1 (ISO 21606:2007/DAM 1:2020)
Art dentaire - Auxiliaires élastomères utilisés en orthodontie - Amendement 1 (ISO 21606:2007/DAM 1:2020)
Zobozdravstvo - Elastomerni pripomočki za uporabo v ortodontiji - Dopolnilo A1 (ISO 21606:2007/DAM 1:2020)
General Information
- Status
- Not Published
- Publication Date
- 22-Nov-2021
- Withdrawal Date
- 22-May-2022
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 4098 - Decision to abandon - Enquiry
- Start Date
- 12-Feb-2021
- Completion Date
- 14-Apr-2025
Relations
- Amends
EN ISO 21606:2007 - Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007) - Effective Date
- 18-Dec-2019
Overview
EN ISO 21606:2007/prA1 (ISO 21606:2007/DAM 1:2020) is an amendment to the international standard for dentistry - elastomeric auxiliaries for use in orthodontics. Published as a draft amendment through ISO/TC 106/SC 1 and adopted in CEN as EN ISO 21606:2007/prA1, the document updates test methods, sampling and clause numbering and clarifies requirements for dimensions and mechanical performance of elastomeric orthodontic components (for example elastic bands, ligatures and separators). This amendment emphasizes type testing, environmental conditions for measurements, and alignment of test results with manufacturer-specified ranges.
Key Topics
Scope and status
- Amendment to ISO 21606:2007 circulated for comment and approval (ISO 21606:2007/DAM 1:2020).
- Prepared by ISO/TC 106 (Dentistry), SC 1.
Test methods and sampling
- All tests defined are type tests; type tests shall be performed on representative samples.
- Sampling and clause numbering were revised to streamline test procedure references.
Environmental conditions
- Force determinations to be performed at (23 ± 2) °C and (50 ± 10) % relative humidity unless otherwise stated.
Mechanical performance requirements
- Dimensions: measured per clause 5.3 and must comply with ranges stated by the manufacturer.
- Initial extension force (F0): when measured per clause 5.4 must fall within the manufacturer’s stated range.
- 24 h residual force (F24): when measured per clause 5.5 must be within the manufacturer’s stated range.
- Ultimate extension (A) for separators: when measured per clause 5.6 must meet or exceed the manufacturer’s stated range.
- If a specimen breaks during testing it is considered a failure; test results must be within the manufacturer’s specified range to comply.
Applications
- Manufacturers of orthodontic elastomeric components use the standard to define product specifications, quality control protocols and to demonstrate compliance with recognized test methods.
- Testing laboratories adopt the amended test procedures and environmental conditions for reliable, repeatable force and dimensional testing (initial force, residual force, ultimate extension).
- Regulatory and procurement bodies reference this standard when evaluating product safety, labeling and conformity with dental material norms.
- Dental professionals and quality managers can use the standard’s requirements to compare product performance claims and ensure clinical expectations are met.
Related standards
- Associated with the work of ISO/TC 106 (Dentistry) and other ISO dental materials standards. Users should cross-reference the principal ISO 21606:2007 text and other dental materials standards for comprehensive compliance and harmonized test methods.
Frequently Asked Questions
EN ISO 21606:2007/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)". This standard covers: Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)
Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)
EN ISO 21606:2007/prA1 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 21606:2007/prA1 has the following relationships with other standards: It is inter standard links to EN ISO 21606:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 21606:2007/prA1 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-julij-2020
Zobozdravstvo - Elastomerni pripomočki za uporabo v ortodontiji - Dopolnilo A1
(ISO 21606:2007/DAM 1:2020)
Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO
21606:2007/DAM 1:2020)
Zahnheilkunde - Elastomere Elemente für die Kieferorthopädie - ÄNDERUNG 1 (ISO
21606:2007/DAM 1:2020)
Art dentaire - Auxiliaires élastomères utilisés en orthodontie - Amendement 1 (ISO
21606:2007/DAM 1:2020)
Ta slovenski standard je istoveten z: EN ISO 21606:2007/prA1
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT AMENDMENT
ISO 21606:2007/DAM 1
ISO/TC 106/SC 1 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2020-04-29 2020-07-22
Dentistry — Elastomeric auxiliaries for use in orthodontics
AMENDMENT 1
Art dentaire — Auxiliaires élastomères utilisés en orthodontie
AMENDEMENT 1
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 21606:2007/DAM 1:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
ISO 21606:2007/DAM 1:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 21606:2007/DAM 1:2020(E)
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