SIST 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.
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
...
Frequently Asked Questions
SIST EN ISO 3630-5:2020 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN ISO 3630-5:2020 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 3630-5:2020 has the following relationships with other standards: It is inter standard links to SIST 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 SIST 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 SIST standards.
SIST EN ISO 3630-5:2020 표준은 치과 분야에서 루트관(근관)의 형성 및 세척에 사용되는 수동 및 기계 작동 도구에 관한 요구 사항과 시험 방법을 규정하고 있습니다. 이 표준은 특히 ISO 3630 시리즈의 다른 부분에서 다루어지지 않는 도구에 대한 규정을 포함하고 있어, 전문가들에게 유용한 참고 자료가 됩니다. 이 표준의 강점 중 하나는 루트관 형성과 세척을 위한 기구의 크기, 표시, 제품 지정, 안전 고려 사항, 라벨링 및 포장에 대한 명확한 요구 사항을 제시한다는 점입니다. 이러한 세부 규정은 치과 의사가 안전하고 효과적인 치료를 제공할 수 있도록 도우며, 환자의 안전성을 높이는 데 기여합니다. SIST EN ISO 3630-5:2020의 관련성은 루트관 치료가 치과 치료에서 점점 더 중요한 분야로 떠오르고 있다는 사실에서 더욱 부각됩니다. 이 표준은 최신 기술과 임상 실무에서 요구되는 안전 기준을 충족하기 위해 지속적으로 업데이트될 필요성이 있으며, 치과 기구의 품질을 보장하기 위한 기준으로서의 역할을 강화합니다. 따라서, 이 표준은 치과 의사 및 제조업체에게 필수적인 지침을 제공하여, 루트관 치료에 있어 효과적인 기구 사용과 환자의 안전을 보장하는 데 크게 기여할 것입니다.
The SIST EN ISO 3630-5:2020 standard provides a comprehensive framework for the requirements and test methods specific to hand-held and mechanically operated instruments used in the shaping and cleaning of root canals. This standard is a crucial addition to the ISO 3630 series, ensuring that instruments not covered in prior parts adhere to established safety and efficacy benchmarks. One of the key strengths of this standard is its clear definition of product specifications relating to size, marking, product designation, safety considerations, labelling, and packaging. By stipulating these requirements, the standard enhances the consistency and reliability of endodontic instruments, thus supporting safe and effective dental practices. The emphasis on safety considerations is particularly noteworthy, as it helps to minimize risks to both practitioners and patients during endodontic procedures. Moreover, the testing methods outlined in the document provide a systematic approach to verifying that instruments meet the set requirements, thereby fostering a higher quality of endodontic care. This relevance is heightened in the context of evolving dental technologies, as this standard adapts to ensure that innovations in shaping and cleaning instruments are appropriately vetted. In summary, SIST EN ISO 3630-5:2020 plays a vital role in standardizing endodontic instruments, ensuring safety, efficacy, and high-quality dental practice. Its comprehensive scope and clear requirements make it a valuable resource for manufacturers and dental professionals alike, reinforcing the importance of adherence to established standards in the field of dentistry.
La norme SIST EN ISO 3630-5:2020 est essentielle pour le domaine dentaire, stipulant les exigences et méthodes d'essai concernant les instruments manuels et mécaniques utilisés pour le modelage et le nettoyage des canaux radiculaires. En tant que partie intégrante de la série ISO 3630, cette norme se concentre spécifiquement sur les instruments non couverts par d'autres parties de la norme, offrant ainsi une portée ciblée qui répond aux besoins variés des praticiens en endodontie. Parmi les forces de la norme, on note la clarté des spécifications relatives à la taille des instruments, au marquage et à la désignation des produits. Ces éléments garantissent une compréhension uniforme et facilitent l'utilisation correcte des instruments, ce qui est crucial pour la sécurité et l'efficacité des traitements endodontiques. De plus, la norme aborde des considérations de sécurité rigoureuses, assurant que les équipements respectent les standards les plus élevés pour protéger les patients et le personnel dentaire. La pertinence de la norme SIST EN ISO 3630-5:2020 se manifeste également dans son approche systématique du conditionnement et de l'étiquetage, offrant ainsi les directives nécessaires pour une présentation claire et professionnelle des instruments. Cela favorise non seulement une meilleure reconnaissance par les praticiens, mais renforce également la confiance des patients dans le choix des outils utilisés lors des traitements dentaires. En résumé, la norme SIST EN ISO 3630-5:2020 représente un outil précieux pour les professionnels de l'endodontie, consolidant les exigences techniques et de sécurité essentielles dans le domaine des instruments de modelage et de nettoyage des canaux radiculaires.
SIST EN ISO 3630-5:2020は、歯科医療の分野において特に重要な役割を果たす標準化文書です。この標準は、根管の形成および清掃に使用される手動および機械的操作の器具に関する要件と試験方法を規定しています。他のISO 3630シリーズの部分で指定されていない器具に焦点を当てており、さまざまな器具の特性を明確に定義しています。 この標準の強みは、サイズ、マーキング、製品の指名、セーフティに関する考慮事項、ラベリングおよび包装に関する要件が詳述されている点です。これにより、製品の一貫性と使いやすさが保証され、歯科医療従事者にとって非常に有益です。また、規格は国際的な基準に基づいているため、異なる地域や国での標準化も促進されます。 SIST EN ISO 3630-5:2020は、用途に応じた器具の性能を最適化することで、患者の安全性と治療の効果を向上させることに貢献しています。この文書は、歯科治療の信頼性を高めるための不可欠な基盤を提供し、最新の技術や材料に適応しています。これにより、歯科医療の質をさらに向上させることが期待できるため、業界において不可欠な参照としての意義を持っています。
Die SIST EN ISO 3630-5:2020 ist ein bedeutendes Dokument im Bereich der Zahnmedizin, das sich auf die Endodontie konzentriert. Diese Norm legt die Anforderungen und Prüfmethoden für Handinstrumente und mechanisch betriebene Instrumente fest, die zum Formen und Reinigen von Wurzelkanälen verwendet werden. Insbesondere sind diese Instrumente in den vorangegangenen Teilen der ISO 3630 Serie nicht spezifiziert. Ein wesentlicher Vorteil der SIST EN ISO 3630-5:2020 ist die umfassende Abdeckung der Sicherheitsaspekte, die für den ordnungsgemäßen Einsatz der Instrumente entscheidend sind. Die Norm legt klare Vorgaben für die Größe, Kennzeichnung und Produktauszeichnung fest, was für die Qualität und Nutzungssicherheit der Endodontie-Instrumente von größter Bedeutung ist. Eine einheitliche Kennzeichnung und Verpackung dieser Instrumente verbessert nicht nur die Benutzerfreundlichkeit, sondern trägt auch zur Minimierung von Verwechslungen und Fehlerquellen bei. Die Relevanz der SIST EN ISO 3630-5:2020 ist in der stetig wachsenden Zahnmedizin und insbesondere in der Endodontie zu sehen. Die Norm stellt sicher, dass alle verwendeten Instrumente den höchsten Anforderungen an die Qualität entsprechen, was zu besseren Behandlungsergebnissen für Patienten führen kann. Durch die Festlegung von Standards wird zudem die Kompatibilität zwischen verschiedenen Herstellern und deren Produkten gefördert, was für Zahnärzte und Praxen von Vorteil ist. Insgesamt stärkt die SIST EN ISO 3630-5:2020 das Vertrauen in die Endodontie-Instrumente und unterstützt Zahnmediziner dabei, qualitativ hochwertige und sichere Behandlungen anzubieten. Die Norm ist somit nicht nur ein wichtiger Leitfaden für die Herstellung und den Einsatz, sondern auch ein Schritt in Richtung einer standardisierten Praxis in der Zahnmedizin.
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