Dentistry - Excavators (ISO 23940:2021)

This document specifies dimensions and performance requirements for excavators used in dentistry.

Zahnheilkunde - Exkavatoren (ISO 23940:2021)

Dieses Dokument legt Maße und Leistungsanforderungen für in der Zahnheilkunde verwendete Exkavatoren fest.

Médecine bucco-dentaire - Excavateurs (ISO 23940:2021)

Le présent document spécifie les dimensions et les exigences de performance des excavateurs utilisés en médecine bucco-dentaire.

Zobozdravstvo - Ekskavatorji (ISO 23940:2021)

General Information

Status
Published
Public Enquiry End Date
19-Feb-2020
Publication Date
29-Jun-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jun-2021
Due Date
16-Aug-2021
Completion Date
30-Jun-2021

Relations

Overview

EN ISO 23940:2021 - Dentistry - Excavators (ISO 23940:2021) specifies the accepted dimensions and performance requirements for handheld dental excavators. Endorsed by CEN and identical to ISO 23940:2021, this standard replaces the earlier ISO 13397-4 and defines shapes, measurement points, material and labelling requirements to ensure consistency, safety and interchangeability of dental excavators used in clinical practice.

Key topics and technical requirements

  • Classification and shapes: Defines five main form groups (A–E) - Straight, Angled, Contra‑angled, Angled complex and Spoon - with numbered types for common working-end geometries.
  • Design and dimensions: Precise dimensional requirements and tolerances for blade width, thickness, length, neck thickness, blade/shank height, blade angle and offset angle. Measurement points and methods are specified.
  • Materials and hardness: Refers to suitable materials (see ISO 21850-1 for stainless steel) and requires Vickers hardness testing according to ISO 6507-1 for the working end.
  • Surface finish and construction: Requirements for surface quality and the connection between working end and handle, including mechanical strength tests.
  • Connection tests: Specifies mechanical tests for the working end–handle connection - tensile and torque tests (noting the updated values in the 2021 edition).
  • Reprocessing resistance: Criteria and test methods for resistance to repeated sterilization/processing cycles (see ISO 17664 for processing information).
  • Marking and labelling: Mandatory instrument marking, package labelling and instructions for use. Includes requirement for a UDI-code and use of standard symbols (ISO 15223-1).

Practical applications and users

Who benefits from implementing EN ISO 23940:2021:

  • Manufacturers and product designers - to design, dimension and validate compliant dental excavators and packaging.
  • Quality managers and test labs - for incoming inspection, dimensional control, hardness testing and reprocessing validation.
  • Regulatory and procurement teams - to reference standardised specifications in conformity assessments and purchase specifications.
  • Dental clinics and sterile processing departments - to understand reprocessing limits, traceability (UDI) and instrument interchangeability. Practical uses include product development, certification, supplier control, sterilization protocol validation and procurement of standardized dental instruments.

Related standards

Normative references in EN ISO 23940:2021 include:

  • ISO 1942 (Dentistry - Vocabulary)
  • ISO 6507-1 (Vickers hardness test)
  • ISO 15223-1 (Medical device symbols)
  • ISO 17664 (Processing information for medical devices)
  • ISO 21850-1 (Materials for dental instruments - stainless steel) This standard supersedes ISO 13397-4:1997 and is the authoritative reference for dental excavator dimensions and performance.
Standard
SIST EN ISO 23940:2021
English language
18 pages
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Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 13397-4:2000
Zobozdravstvo - Ekskavatorji (ISO 23940:2021)
Dentistry - Excavators (ISO 23940:2021)
Zahnheilkunde - Exkavatoren (ISO 23940:2021)
Médecine bucco-dentaire - Excavateurs (ISO 23940:2021)
Ta slovenski standard je istoveten z: EN ISO 23940:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23940
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 13397-4:1997
English Version
Dentistry - Excavators (ISO 23940:2021)
Médecine bucco-dentaire - Excavateurs (ISO Zahnheilkunde - Exkavatoren (ISO 23940:2021)
23940:2021)
This European Standard was approved by CEN on 13 March 2021.

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, 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 23940:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23940:2021) 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 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 November 2021, and conflicting national standards
shall be withdrawn at the latest by November 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.
This document supersedes EN ISO 13397-4:1997.
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 23940:2021 has been approved by CEN as EN ISO 23940:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23940
First edition
2021-04
Dentistry — Excavators
Médecine bucco-dentaire — Excavateurs
Reference number
ISO 23940:2021(E)
©
ISO 2021
ISO 23940:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 23940:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 2
5 Classification . 2
6 Requirements for excavators . 2
6.1 Design and dimensions . 2
6.2 Maximum overall length . 9
6.3 Location of measurement points . 9
6.4 Material . 9
6.5 Vickers hardness of the working end . 9
6.6 Surface finish . 9
6.7 Connection between working end and handle .10
6.8 Resistance to reprocessing .10
7 Measurement and test methods .10
7.1 Visual inspection .10
7.2 Dimensions .10
7.3 Resistance to reprocessing .10
7.4 Connection between working end and handle .10
7.4.1 Tensile force test .10
7.4.2 Torque test .11
8 Marking and labelling .11
8.1 Marking on the instrument .11
8.2 Labelling on the package .11
8.3 Instructions for use .11
ISO 23940:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This first edition cancels and replaces the first edition (ISO 13397-4:1997), which has
...

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Frequently Asked Questions

SIST EN ISO 23940:2021 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Excavators (ISO 23940:2021)". This standard covers: This document specifies dimensions and performance requirements for excavators used in dentistry.

This document specifies dimensions and performance requirements for excavators used in dentistry.

SIST EN ISO 23940:2021 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN ISO 23940:2021 has the following relationships with other standards: It is inter standard links to SIST EN ISO 13397-4:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase SIST EN ISO 23940:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.

記事のタイトル:SIST EN ISO 23940:2021 - 歯科 - エキスカベータ(ISO 23940:2021) 記事の内容:この文書は、歯科で使用されるエキスカベータの寸法と性能要件を明示しています。

The article discusses the standard SIST EN ISO 23940:2021, which focuses on excavators used in dentistry. It specifies the dimensions and performance requirements for these dental tools.

기사 제목: SIST EN ISO 23940:2021 - 치과 - 파출기 (ISO 23940:2021) 기사 내용: 본 문서는 치과에서 사용되는 파출기의 치수 및 성능 요구 사항을 명시합니다.