SIST EN ISO 3630-2:2023
(Main)Dentistry - Endodontic instruments - Part 2: Enlargers (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
Relations
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.
Frequently Asked Questions
SIST EN ISO 3630-2:2023 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)". This standard covers: 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.
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.
SIST EN ISO 3630-2:2023 is classified under the following ICS (International Classification for Standards) categories: 11.060.20 - Dental equipment; 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 3630-2:2023 has the following relationships with other standards: It is inter standard links to SIST EN ISO 3630-2:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 3630-2:2023 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.
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: +41 22 749 01 11
Email: copyright@iso.org
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
...
Die SIST EN ISO 3630-2:2023 bietet einen umfassenden Rahmen für die Standardisierung von Endodontie-Instrumenten, insbesondere für Vergrößerungsinstrumente. Dieser Standard ist von entscheidender Bedeutung für Hersteller und medizinische Fachkräfte, da er spezifische Anforderungen für Vergrößerungsinstrumente festlegt, die nicht in anderen Teilen der ISO 3630-Serie behandelt werden. Ein hervorstechendes Merkmal des Standards ist die präzise Definition von Größenanforderungen, die sicherstellt, dass die Instrumente optimal und konsistent produziert werden. Darüber hinaus behandelt der Standard die Kennzeichnung und Produktbezeichnung, was für die Rückverfolgbarkeit und Identifizierung von großer Bedeutung ist. Die Sicherheitsüberlegungen tragen dazu bei, das Risiko von Verletzungen und Fehlbedienungen zu minimieren, was sowohl für die Anwender als auch für die Patienten von hoher Relevanz ist. Ein weiterer Stärke der SIST EN ISO 3630-2:2023 ist die detaillierte Anleitung zur Kennzeichnung und Verpackung der Produkte, einschließlich der Gebrauchsanweisungen. Dies gewährleistet, dass Nutzer über alle notwendigen Informationen verfügen, um die Instrumente sicher und effektiv anzuwenden. Insgesamt ist die SIST EN ISO 3630-2:2023 von erheblicher Relevanz für den Bereich der Zahnmedizin, insbesondere für die Endodontie. Die klaren Vorgaben zur Sicherheit, Qualität und Benutzerfreundlichkeit der Vergrößerungsinstrumente tragen nicht nur zur Verbesserung der klinischen Praxis bei, sondern fördern auch das Vertrauen in die Produkte innerhalb der zahnmedizinischen Gemeinschaft.
SIST EN ISO 3630-2:2023은 치과 분야에서 사용되는 확장 기구에 대한 요구사항을 명확하게 규정한 문서입니다. 이 표준은 ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6, ISO 3630-7에서 다루지 않은 확장 기구에 대한 규정을 포함하고 있어 그 범위가 매우 중요합니다. 이 문서는 확장 기구의 크기, 마킹, 제품 지정, 안전 고려 사항, 라벨링 및 포장 방법뿐만 아니라 사용 설명서에 대한 요구사항을 상세히 명시함으로써, 제조업체와 사용자 간의 명확한 이해를 돕습니다. 이러한 구체적인 요구 사항들은 품질을 보장하고, 사용자 안전을 최우선으로 하며, 제품의 일관성을 유지하는 데 기여합니다. SIST EN ISO 3630-2:2023의 강점은 치과 기구 시장에서의 표준화를 통해 업계의 신뢰성을 높이고, 사용자 및 환자에게 안전하고 효과적인 제품을 제공할 수 있도록 하는 데 있습니다. 또한, 이 표준은 국제 기준에 맞춰 개발되어, 글로발 시장에서의 경쟁력을 강화하는 데 필요한 요소로 자리 잡고 있습니다. 따라서, SIST EN ISO 3630-2:2023은 치과 분야에서 확장 기구의 개발과 사용에 있어 필수적으로 고려해야 할 기준으로, 이 문서의 채택은 제조업체뿐만 아니라 임상 현장에서 사용되는 모든 치과 전문인에게도 큰 이점이 될 것입니다.
The SIST EN ISO 3630-2:2023 standard provides a comprehensive framework for endodontic instruments, specifically focusing on enlargers that are not covered under the preceding parts of ISO 3630. The scope of the standard is well-defined, ensuring that it addresses the necessary requirements regarding size, marking, product designation, safety considerations, as well as labeling and packaging, including detailed instructions for use. One of the notable strengths of this standard is its attention to safety considerations, which is paramount in the field of dentistry. By establishing clear safety guidelines, the document aims to enhance patient safety and minimize risks associated with the use of endodontic enlargers. Furthermore, the standard’s emphasis on product designation and marking helps facilitate better identification and traceability in clinical settings, ensuring that dental practitioners can make informed choices about the tools they use. The relevance of this standard in contemporary dental practice cannot be overstated. As endodontic procedures continue to evolve, the necessity for standardized instruments that meet rigorous safety and performance criteria becomes increasingly critical. The SIST EN ISO 3630-2:2023 standard addresses this need by providing manufacturers and practitioners with essential guidance, ultimately contributing to improved treatment outcomes and enhanced patient care. Overall, the SIST EN ISO 3630-2:2023 standard is a significant addition to the body of guidelines governing endodontic instruments, positioning itself as a vital resource for ensuring quality and safety in dental practice.
La norme SIST EN ISO 3630-2:2023, intitulée "Dentisterie - Instruments endodontiques - Partie 2 : Élargisseurs", constitue un document essentiel pour les professionnels du secteur dentaire, spécifiant les exigences relatives aux élargisseurs qui ne sont pas abordés dans les autres parties de la norme ISO 3630. Cette norme est particulièrement pertinente pour les praticiens qui souhaitent garantir la qualité et la sécurité de leurs instruments endodontiques. L'une des forces majeures de cette norme réside dans sa portée. En définissant clairement les exigences en matière de taille, de marquage, de désignation des produits, de considérations de sécurité, ainsi que d'étiquetage et d'emballage, elle permet à tous les acteurs du secteur de se conformer à des standards élevés de qualité. Cela est crucial pour assurer non seulement l'efficacité des élargisseurs, mais aussi la sécurité des patients. De plus, le document présente des instructions d'utilisation claires, ce qui facilite l'adoption de ces instruments par les dentists. Cela contribue à une meilleure formation des praticiens, leur permettant d'utiliser correctement les élargisseurs et d'optimiser les résultats cliniques. La norme SIST EN ISO 3630-2:2023 est éveillée à l'importance croissante de la sécurité dans le milieu dentaire, mettant en avant des considérations qui garantissent que les produits ne présentent pas de risques pour les patients. Son approche méthodique et standardisée répond également à la nécessité de transparence dans le domaine de l'endodontie. En conclusion, la norme SIST EN ISO 3630-2:2023 se révèle être un document incontournable pour quiconque est impliqué dans la dentisterie endodontique, en offrant des lignes directrices claires et rigoureuses qui renforcent la sécurisation des pratiques dans le traitement des canaux radiculaires.
SIST EN ISO 3630-2:2023は、歯科用エンドカンファルスの領域における拡大器具に関する重要な標準です。この文書は、ISO 3630-1、ISO 3630-3、ISO 3630-4、ISO 3630-5、ISO TR 3630-6、ISO 3630-7で言及されていない拡大器具の要求事項を明確に示しています。 この標準の強みは、その範囲が明確であり、特に拡大器特有の要求事項を詳細に記載している点にあります。サイズ、マーキング、製品の指定、安全性の考慮事項、ラベリング及び包装についての要件が定義されており、使用説明書に関する指針も含まれています。これにより、製造業者や使用者にとっての指針として機能し、製品の安全性や効果性の向上に寄与しています。 また、SIST EN ISO 3630-2:2023は、エンドodonticsにおける治療の質を高めるための基準を提供しており、歯科医師や技術者が国際的な洗練された基準を満たすことを可能にします。この標準は、歯科医療の分野で高い関連性を持ち、国際的な取引や標準化を推進する重要な役割を果たしています。
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...