EN ISO 3630-2:2023

Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)

This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7.
This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2023)

Dieses Dokument legt Anforderungen und Prüfverfahren für Erweiterer fest, die in ISO 3630 1, ISO 3630 3, ISO 3630 4, ISO 3630 5, ISO/TR 3630 6  oder ISO 3630 7  nicht enthalten sind.
Dieses Dokument legt Anforderungen an Größe, Kennzeichnung, Produktbezeichnung, Sicherheitsbetrachtungen, und Etikettierung und Verpackung sowie an die Gebrauchsanweisung fest.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-2:2023)

Le présent document spécifie les exigences relatives aux élargisseurs non cités dans l’ISO 3630-1, l’ISO 3630-3, l’ISO 3630-4, l’ISO 3630-5, l’ISO TR 3630-6 ou l’ISO 3630-7.
Le présent document spécifie les exigences concernant la dimension, le marquage, la désignation du produit, les considérations de sécurité, l’étiquetage et l’emballage, ainsi que les instructions d’utilisation.

Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-2:2023)

Ta dokument določa zahteve za razširjevalnike, ki niso navedeni v standardih, ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 ali ISO 3630-7.
Ta dokument določa posebne zahteve za velikost, označevanje, namembnost izdelka, varnostne napotke, etiketiranje in pakiranje, vključno z navodili za uporabo.

General Information

• Status: Published
• Publication Date: 14-Feb-2023
• 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: 15-Feb-2023
• Completion Date: 15-Feb-2023
• Ref Project: SIST EN ISO 3630-2:2023 - Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)

Relations

• Replaces: EN ISO 3630-2:2013 - Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)
• Effective Date: 07-Nov-2018

Overview

EN ISO 3630-2:2023 (ISO 3630-2:2023) – Dentistry - Endodontic instruments - Part 2: Enlargers - is the fourth-edition international / European standard, published by CEN in February 2023. It specifies requirements for enlargers not covered by other parts of the ISO 3630 series and sets rules for size, marking, product designation, safety, labelling, packaging and instructions for use. The document harmonizes testing and classification across the ISO 3630 family and supersedes EN ISO 3630-2:2013.

Key topics and technical requirements

• Scope and definitions: defines “enlarger” (engine‑driven endodontic instrument used to improve access) and scope relative to other ISO 3630 parts.
• Classification: describes enlarger types (B1, B2, G, M, P) to standardize product families and designation.
• Materials: requirements for shank and working part materials and references for material-related safety.
• Dimensions and blades: specification of dimensional checks, designation conventions and number of blades (nominal size denotation uses dm rather than the generic D).
• Mechanical performance:
  • resistance to fracture by twisting and angular deflection
  • resistance to bending
  • resistance to fatigue
  • prescribed fracture location assessment
• Reprocessing resistance: criteria for repeated sterilization/reprocessing and durability.
• Sampling and testing: sampling plans and test methods for dimensions, tip, shank, lengths, blades and mechanical tests; test report requirements.
• Product information: mandatory marking, labelling, packaging and clear instructions for use to support safe clinical application.

Practical applications and who uses it

• Manufacturers and designers of endodontic enlargers use the standard to design compliant, testable products and create accurate product designations.
• Quality assurance and testing laboratories apply the sampling and mechanical test methods for conformity assessment and product release.
• Regulatory and compliance teams rely on EN ISO 3630-2:2023 text (adopted as an EN standard across CEN members) to demonstrate harmonized safety and performance when preparing technical documentation.
• Procurement and clinical engineers use the labeling and packaging requirements to verify device traceability, instructions for use and sterilization compatibility.
• Dental professionals benefit indirectly through improved device safety, labelling clarity and predictable mechanical performance.

Related standards

• ISO 3630-1:2019 - General requirements for endodontic instruments
• Other parts of ISO 3630 series - for files, reamers and related instruments
• ISO 1797 - Shanks for rotary and oscillating instruments
• ISO 1942 - Dental vocabulary
• Guidance for biological/toxicological assessment: ISO 10993-1, ISO 7405

EN ISO 3630-2:2023 is essential for aligning product design, testing and labeling of endodontic enlargers with internationally harmonized requirements.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-
2:2023)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)
Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-
2:2023)
Ta slovenski standard je istoveten z: EN ISO 3630-2:2023
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 3630-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-2:2013
English Version
Dentistry - Endodontic instruments - Part 2: Enlargers
(ISO 3630-2:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 2:
Partie 2: Élargisseurs (ISO 3630-2:2023) Erweiterer (ISO 3630-2:2023)
This European Standard was approved by CEN on 24 December 2022.

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, 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-2:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 3630-2:2023) 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 August 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
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 3630-2:2013.
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 3630-2:2023 has been approved by CEN as EN ISO 3630-2:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 3630-2
Fourth edition
2023-02
Dentistry — Endodontic
instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 2: Élargisseurs
Reference number
ISO 3630-2:2023(E)
ISO 3630-2:2023(E)
© ISO 2023
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 3630-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 Terms and definitions . 1
3.2 Symbols . 1
4 Classification . 2
4.1 Enlarger Type B1 . 2
4.2 Enlarger Type B2 . 2
4.3 Enlarger Type G . 2
4.4 Enlarger Type M . 2
4.5 Enlarger Type P . 2
5 Requirements . 2
5.1 Materials . 2
5.1.1 Shank . 2
5.1.2 Working part . 3
5.2 Dimensions, designation and number of blades . 3
5.3 Mechanical requirements . 8
5.3.1 Resistance to fracture by twisting and angular deflection . 8
5.3.2 Resistance to bending . 8
5.3.3 Resistance to fatigue . . 8
5.3.4 Fracture location . 8
5.4 Resistance to reprocessing . 9
6 Sampling . 9
7 Testing. 9
7.1 General . 9
7.2 Dimensions . 9
7.2.1 Diameters . . 9
7.2.2 Tip . 9
7.2.3 Shank . 9
7.2.4 Lengths . 9
7.2.5 Blades . 9
7.3 Resistance to fracture by twisting and angular deflection . . 9
7.4 Resistance to bending . 10
7.5 Resistance to fatigue . 10
7.6 Fracture location . 10
7.7 Test report . 11
8 Product information .12
8.1 Marking .12
8.2 Labelling . 12
8.3 Packaging .12
8.4 Instructions for use .12
Bibliography .13
iii
ISO 3630-2:2023(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, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 3630-2:2013), which has been technically
revised.
The main changes are as follows:
— symbols have been redefined;
— the test method has been redefined;
— this document has been harmonized with other parts of the ISO 3630 series.
A list of all parts in the ISO 3630 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
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