EN ISO 7711-1:2021/A1:2025

Dentistry - Diamond rotary instruments - Part 1: General requirements - Amendment 1 (ISO 7711-1:2021/Amd 1:2025)

Zahnheilkunde - Rotierende Diamantinstrumente - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO 7711-1:2021/Amd 1:2025)

Médecine bucco-dentaire - Instruments rotatifs diamantés - Partie 1: Exigences générales - Amendement 1 (ISO 7711-1:2021/Amd 1:2025)

Zobozdravstvo - Dentalni diamantni instrumenti - 1. del: Splošne zahteve - Dopolnilo A1 (ISO 7711-1:2021/Amd 1:2025)

General Information

• Status: Published
• Publication Date: 21-Jan-2025
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 22-Jan-2025
• Completion Date: 22-Jan-2025
• Ref Project: SIST EN ISO 7711-1:2022/A1:2025 - Dentistry - Diamond rotary instruments - Part 1: General requirements - Amendment 1 (ISO 7711-1:2021/Amd 1:2025)

Relations

• Amends: EN ISO 7711-1:2021 - Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
• Effective Date: 22-Jan-2023

Overview

EN ISO 7711-1:2021/A1:2025 is Amendment 1 to the international standard ISO 7711-1 (Dentistry - Diamond rotary instruments - Part 1: General requirements). Published as a CEN-endorsed European Standard in January 2025, this amendment (approved by CEN 19 May 2024) updates the general requirements for diamond rotary dental instruments and is to be implemented by CEN members by July 2025. The document amends specific test provisions to better align laboratory test conditions with clinical experience.

Key Topics and Requirements

• Addition of two new subclauses to clause 5.4:
  • 5.4.3.1 General - introduces the new subclause header (see standard for full text).
  • 5.4.3.2 Limit of the test force - establishes limits on test force when using the test-force formula.
• Test force constraint:
  • When calculating test force per 5.4.3.1, the maximum test force shall not exceed 60 N.
  • The amendment notes that instruments with very short working-part lengths and large diameters can produce very high calculated test forces that are not representative of clinical use; it references that typically 2 N is recommended in clinical use.
• Formal endorsement: The amendment is published as EN ISO 7711-1:2021/A1:2025 and was adopted without modification from the ISO text.

Applications and Who Uses It

This amendment is relevant for:

• Dental instrument manufacturers - to ensure product testing and declarations meet updated force limits and general requirements for diamond rotary instruments.
• Test laboratories and quality assurance teams - for adapting mechanical testing protocols and reporting to comply with the new maximum test-force limit.
• Regulatory bodies and notified bodies - for conformity assessment and to interpret test data against the amended standard.
• Procurement specialists and clinical engineers - evaluating supplier test data and device suitability.
• Dental clinicians and educators - to understand standardized test conditions versus typical clinical forces.

Practical value: the amendment reduces the risk of overestimating mechanical stress during bench tests and aligns laboratory procedures more closely with real-world clinical loading of diamond rotary instruments.

Related Standards

• ISO 7711 series - other parts of the ISO 7711 series cover additional aspects of diamond rotary instruments; a complete list is available on the ISO website.
• EN ISO 7711-1:2021 - base document amended by A1:2025.

Keywords: dentistry standard, diamond rotary instruments, ISO 7711-1, EN ISO 7711-1:2021/A1:2025, test force limit, dental instrument testing, CEN standard.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2025
Zobozdravstvo - Dentalni diamantni instrumenti - 1. del: Splošne zahteve -
Dopolnilo A1 (ISO 7711-1:2021/Amd 1:2025)
Dentistry - Diamond rotary instruments - Part 1: General requirements - Amendment 1
(ISO 7711-1:2021/Amd 1:2025)
Zahnheilkunde - Rotierende Diamantinstrumente - Teil 1: Allgemeine Anforderungen -
ÄNDERUNG 1 (ISO 7711-1:2021/Amd 1:2025)
Médecine bucco-dentaire - Instruments rotatifs diamantés - Partie 1: Exigences
générales - Amendement 1 (ISO 7711-1:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 7711-1:2021/A1:2025
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7711-1:2021/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2025
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Diamond rotary instruments - Part 1: General
requirements - Amendment 1 (ISO 7711-1:2021/Amd
1:2025)
Médecine bucco-dentaire - Instruments rotatifs Zahnheilkunde - Rotierende Diamantinstrumente - Teil
diamantés - Partie 1: Exigences générales - 1: Allgemeine Anforderungen - Änderung 1 (ISO 7711-
Amendement 1 (ISO 7711-1:2021/Amd 1:2025) 1:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 7711-1:2021; it was approved by CEN on 19 May 2024.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7711-1:2021/A1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7711-1:2021/A1:2025) 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 7711-1:2021 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by July 2025, and
conflicting national standards shall be withdrawn at the latest by July 2025.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7711-1:2021/Amd 1:2025 has been approved by CEN as EN ISO 7711-1:2021/A1:2025
without any modification.
...