EN ISO 3630-5:2020
(Main)Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2020)
Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2020)
This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series.
This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.
Zahnheilkunde - Endodontische Instrumente - Teil 5: Form- und Reinigungsinstrumente (ISO 3630-5:2020)
Dieses Dokument legt Anforderungen an und Prüfverfahren für handgehaltene oder mechanisch betätigte Instrumente fest, die zum Formen und Reinigen von Wurzelkanälen verwendet werden und die nicht in den anderen Teilen der Reihe ISO 3630 beschrieben werden.
Dieses Dokument legt Anforderungen an Größe, Markierung, Produktbezeichnung, Sicherheits-überlegungen, Kennzeichnung und Verpackung fest.
Médecine bucco-dentaire - Instruments d'endodontie - Partie 5: Instruments de mise en forme et de nettoyage (ISO 3630-5:2020)
Le présent document spécifie les exigences et méthodes d'essai relatives aux instruments à usage manuel et mécanique utilisés pour la mise en forme et le nettoyage des canaux radiculaires, et qui ne sont pas spécifiées dans les autres parties de la série ISO 3630.
Le présent document spécifie les exigences relatives à la taille, au marquage, à la désignation des produits et aux considérations de sécurité, ainsi qu'à leur étiquetage et emballage.
Zobozdravstvo - Instrumenti za zobni kanal - 5. del: Instrumenti za oblikovanje in čiščenje (ISO 3630-5:2020)
General Information
Relations
Overview - EN ISO 3630-5:2020 (Endodontic instruments - Shaping & cleaning)
EN ISO 3630-5:2020 (CEN adoption of ISO 3630-5:2020) specifies requirements and test methods for hand‑held and mechanically operated endodontic shaping and cleaning instruments used in root canal treatment when those instruments are not covered by other parts of the ISO 3630 series. The standard covers size, marking, product designation, safety considerations, labelling and packaging and is intended for manufacturers, test laboratories and conformity assessors.
Key topics and technical requirements
- Scope & classification
- Applies to shaping and cleaning instruments classified into five classes (see ISO 3630‑1:2019 for classification rules).
- Materials
- Materials for working parts, shanks and handles are at the manufacturer’s discretion but must meet requirements of ISO 3630‑1:2019.
- Dimensions & tolerances
- Nominal diameter, taper and length requirements follow ISO 3630‑1; allowable tolerance rules for identified diameters are given (tolerance less than 75% of the difference between adjacent brand sizes).
- Length specifications include minimum working part length for Class 1 and manufacturer-declared operative/overall lengths with defined tolerances.
- Mechanical performance
- Specifies minimum resistance to fracture by twisting and angular deflection (tables define required torque and angular deflection minima by instrument size and class).
- Other mechanical requirements include stiffness and handle/shank security.
- Chemical and sterilization
- Requirements for corrosion resistance and for effects of sterilization (heat) are included.
- Color‑coding, sampling and test methods
- Color‑coding, sampling plans, measurement and test methods are defined to support consistent identification and compliance.
- Reprocessing, marking and packaging
- Resistance to reprocessing, product designation/marking, labelling, instructions for use and packaging requirements are specified.
Practical applications - who uses this standard
- Manufacturers of endodontic files, reamers and shaping tools - to design products that meet European/ISO requirements and declare sizes, lengths and performance.
- Quality and regulatory teams - to demonstrate conformity for CE marking and national approvals.
- Test laboratories - to perform the mechanical, dimensional and corrosion tests specified.
- Procurement and clinical users - for interpreting manufacturer markings, declared sizes and instructions for safe use and reprocessing.
Related standards
- ISO 3630‑1:2019 - General requirements for endodontic instruments
- ISO 1942 - Dentistry vocabulary
- ISO 10993‑1 and ISO 7405 - guidance for biological/toxicological assessment (referenced in the introduction)
- Other parts of the ISO 3630 series for specific instrument types
Keywords: EN ISO 3630-5:2020, endodontic instruments, shaping and cleaning instruments, root canal, test methods, resistance to fracture, dimensions, labelling, packaging, CEN.
Frequently Asked Questions
EN ISO 3630-5:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2020)". This standard covers: This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.
This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.
EN ISO 3630-5:2020 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.
EN ISO 3630-5:2020 has the following relationships with other standards: It is inter standard links to EN ISO 3630-5:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 3630-5:2020 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 CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2020
Nadomešča:
SIST EN ISO 3630-5:2011
Zobozdravstvo - Instrumenti za zobni kanal - 5. del: Instrumenti za oblikovanje in
čiščenje (ISO 3630-5:2020)
Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630
-5:2020)
Zahnheilkunde - Endodontische Instrumente - Teil 5: Form- und Reinigungsinstrumente
(ISO 3630-5:2020)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 5: Instruments de mise en
forme et de nettoyage (ISO 3630-5:2020)
Ta slovenski standard je istoveten z: EN ISO 3630-5:2020
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 3630-5
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-5:2011
English Version
Dentistry - Endodontic instruments - Part 5: Shaping and
cleaning instruments (ISO 3630-5:2020)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 5:
Partie 5: Instruments de mise en forme et de nettoyage Form- und Reinigungsinstrumente (ISO 3630-5:2020)
(ISO 3630-5:2020)
This European Standard was approved by CEN on 7 August 2020.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-5:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 3630-5:2020) 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 March 2021, and conflicting national standards shall
be withdrawn at the latest by March 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 3630-5:2011.
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 3630-5:2020 has been approved by CEN as EN ISO 3630-5:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 3630-5
Second edition
2020-08
Dentistry — Endodontic
instruments —
Part 5:
Shaping and cleaning instruments
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 5: Instruments de mise en forme et de nettoyage
Reference number
ISO 3630-5:2020(E)
©
ISO 2020
ISO 3630-5:2020(E)
© ISO 2020
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 2020 – All rights reserved
ISO 3630-5:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 1
5 Requirements . 1
5.1 Material . 1
5.2 Dimensions . 2
5.2.1 General. 2
5.2.2 Diameter . 2
5.2.3 Length. 2
5.3 Mechanical . 2
5.3.1 Resistance to fracture by twisting and angular deflection . 2
5.3.2 Stiffness . 4
5.3.3 Handle or plastics shank security . 5
5.4 Chemical . 5
5.4.1 Resistance to corrosion . 5
5.4.2 Heat effects of sterilization . 5
5.5 Color-coding . 6
6 Sampling . 6
7 Measurement and test methods . 6
7.1 General . 6
8 Resistance to reprocessing . 6
9 Designation, marking, and identification . 6
10 Packaging . 6
11 Instructions for use . 6
12 Labelling . 6
Bibliography . 7
ISO 3630-5:2020(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
...
SIST EN ISO 3630-5:2020 문서는 치과 분야에서의 근관 형성 및 청소에 사용되는 기구에 대한 표준화 요구사항과 시험 방법을 상세히 규명하고 있습니다. 이 표준은 ISO 3630 시리즈의 다른 부분에서 규정되지 않은 수동 및 기계 작동 기구를 대상으로 하며, 근관 치료의 품질과 안전성을 높이기 위한 필수적 요소들을 포함합니다. 주요 강점 중 하나는 기구의 크기, 표시, 제품 표기법, 안전 고려사항, 라벨링 및 포장을 포함하는 포괄적인 요구사항을 제시한다는 점입니다. 이러한 요소들은 치과의사들이 적절한 기구를 선택하는 데 있어 혼돈을 줄이고, 소모품이 정확히 사용될 수 있도록 돕습니다. 또한, EN ISO 3630-5:2020은 환자의 안전을 최우선으로 고려하여 설계된 점에서 강력한 사항을 제공합니다. 모든 기구는 안전성 기준을 충족해야 하며, 이는 의사와 환자 모두에게 신뢰를 줄 수 있는 기반이 됩니다. 이러한 안전 기준은 특히 감염 관리와 관련하여 중요합니다. 이 표준은 최신 치과 임상 실무와 심미적 요구를 충족시키는데도 매우 적합하여, 현재의 요구사항과 단계에 부응하는 성격을 가집니다. 따라서, EN ISO 3630-5:2020은 근관 치료에서 사용되는 기구의 품질 제고에 기여하며, 치과 전문가들이 안전하고 효과적인 치료를 제공하는 데 있어 중요한 역할을 할 것입니다. 결론적으로, EN ISO 3630-5:2020은 근관 형성과 청소 기구에 대한 명확하고 체계적인 기준을 제시하고 있으며, 이는 치과 분야에서의 안전성과 효율성을 높이는 데 큰 영향을 미칠 것으로 기대됩니다.
La norme EN ISO 3630-5:2020 représente un document essentiel dans le domaine de la dentisterie, en particulier pour les instruments endodontiques. Cette norme précise les exigences et les méthodes d'essai pour les instruments manuels et mécaniquement opérés utilisés pour le façonnement et le nettoyage des canaux radiculaires. Contrairement aux autres parties de la série ISO 3630, cette norme se concentre spécifiquement sur les instruments qui ne sont pas traités ailleurs, ce qui en fait un complément indispensable pour les professionnels du secteur. Parmi les points forts de la norme, on trouve sa clarté dans les spécifications relatives à la taille, au marquage, à la désignation des produits, ainsi qu'aux considérations de sécurité. Ces exigences garantissent que les instruments répondent à des critères stricts de qualité et de sécurité, ce qui est crucial pour la santé des patients. De plus, les directives sur l'étiquetage et l'emballage assurent une identification correcte des instruments, minimisant ainsi les risques d'erreurs lors des interventions endodontiques. La pertinence de la norme EN ISO 3630-5:2020 ne peut être sous-estimée dans le cadre des pratiques contemporaines de dentisterie. En harmonisant les critères de fabrication et de test des instruments endodontiques, elle garantit que les praticiens disposent d'outils fiables et efficaces pour le façonnement et le nettoyage des canaux radiculaires. Cette norme contribue non seulement à l'amélioration de la qualité des soins dentaires, mais également à la promotion de la sécurité des traitements endodontiques. Par conséquent, l'adoption de cette norme par les fabricants et les professionnels est fortement recommandée pour assurer un niveau élevé de soins dentaires.
The EN ISO 3630-5:2020 standard outlines the essential requirements and test methods for hand-held and mechanically operated instruments designed for shaping and cleaning root canals in the field of dentistry. This standard is a critical part of the ISO 3630 series, focusing specifically on instruments that are not covered by the other sections of the series. A significant strength of this document is its comprehensive specification of size, marking, product designation, safety considerations, labeling, and packaging. By establishing clear guidelines for these factors, the standard ensures a uniform understanding of the instruments used within dental practices, promoting consistency and safety in endodontic procedures. The relevance of EN ISO 3630-5:2020 cannot be overstated, particularly in a field where precision and safety are paramount. By adhering to this standard, dental professionals can ensure that the shaping and cleaning instruments they utilize are reliable and meet necessary safety protocols. Furthermore, the inclusion of test methods enhances the confidence in the performance of these instruments, which ultimately contributes to better patient outcomes and overall trust in dental treatments. Overall, this standard plays a vital role in the ongoing effort to standardize endodontic instruments, providing a framework that benefits manufacturers, dental practitioners, and patients alike.
Die Norm EN ISO 3630-5:2020 legt die Anforderungen und Prüfmethoden für manuell und mechanisch betriebene Instrumente fest, die zur Formgebung und Reinigung von Wurzelkanälen eingesetzt werden. Diese Norm ist besonders relevant für die zahnmedizinische Praxis, da sie sicherstellt, dass die verwendeten Endodontie-Instrumente sowohl die erforderlichen Sicherheitsstandards als auch die qualitativen Vorgaben erfüllen. Die Stärken der Norm liegen in der detaillierten Spezifikation der Größe, der Kennzeichnung, der Produktbezeichnung sowie der Sicherheitsüberlegungen, die für die Entwicklung und Verwendung von Formungs- und Reinigungsinstrumenten entscheidend sind. Dies sorgt nicht nur für ein einheitliches Verständnis innerhalb der Branche, sondern minimiert auch das Risiko von Fehlanwendungen, was zu einem besseren Behandlungsergebnis für die Patienten führen kann. Ein weiterer bedeutender Aspekt dieser Norm ist die klare Reglementierung bezüglich der Kennzeichnung und Verpackung der Instrumente. Durch diese Anforderungen wird sichergestellt, dass die Endodontie-Instrumente nachvollziehbar sind und eine optimale Nutzung gewährleisten. Die Norm trägt somit wesentlich zur Verbesserung der Qualität in der Zahnmedizin bei und unterstützt die Fachkräfte dabei, höchste Standards in der Patientenversorgung einzuhalten. Insgesamt stellt die EN ISO 3630-5:2020 eine unverzichtbare Grundlage für die Entwicklung und Anwendung von Endodontie-Instrumenten dar und gewährleistet, dass alle Produkte im Einklang mit den globalen Standards stehen. Dies macht sie zu einer relevanten Richtlinie für Hersteller und Zahnärzte gleichermaßen.
SIST EN ISO 3630-5:2020は、歯科における根管治療用の器具についての標準であり、その範囲は根管の成形および清掃に使用される手動および機械式の器具に関連しています。この標準は、ISO 3630シリーズの他の部分では指定されていない器具に対する要件と試験方法を明確に規定しています。 この文書の強みは、その包括的な要件と詳細な指導が提示されている点です。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、およびパッケージングに関する基準が詳細に記載されているため、業界内での一貫性を確保し、消費者の安全を守ることが可能です。このように、SIST EN ISO 3630-5:2020は、根管治療に使用される器具の品質と安全性を保証するための重要な基盤を提供しています。 さらに、最新の技術とベストプラクティスを反映しているため、歯科医師と患者にとっての関連性も非常に高いと言えます。この標準は、歯科用器具のユーザーにとって信頼できる情報源であり、業界全体の安全性と効率性の向上に寄与しています。
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