SIST EN ISO 20569:2018
(Main)Dentistry - Trephine burs (ISO 20569:2018)
Dentistry - Trephine burs (ISO 20569:2018)
This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.
Zahnheilkunde - Trephinbohrer (ISO 20569:2018)
Dieses Dokument legt die Anforderungen und Prüfverfahren für Trephinbohrer fest, die in der Zahnheilkunde überwiegend für orale Implantologieverfahren verwendet werden, wie zur Knochen-entnahme und/oder zur Entfernung von Implantaten. Es legt außerdem die Anforderungen an deren Kennzeichnung und Etikettierung fest.
Medecine bucco-dentaire - Fraises-trépans (ISO 20569:2018)
Le présent document spécifie les exigences et méthodes d'essai des fraises‐trépans employées dans la médecine bucco‐dentaire, en particulier dans le cadre de procédures d'implantologie buccale telles que les prélèvements osseux et/ou le retrait d'un implant. Il spécifie également les exigences applicables au marquage et à l'étiquetage de ces instruments.
Zobozdravstvo - Svedri za trepaniranje (ISO 20569:2018)
Ta mednarodni standard določa zahteve in povezane preskusne metode za svedre za trepaniranje, ki se v zobozdravstvu uporabljajo zlasti pri postopkih oralne kirurške vsaditve, na primer pri zbiranju kosti in odstranjevanju poškodovanih vsadkov. Določa tudi zahteve za označevanje in etiketiranje.
General Information
- Status
- Published
- Public Enquiry End Date
- 09-Jul-2017
- Publication Date
- 12-Nov-2018
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 05-Nov-2018
- Due Date
- 10-Jan-2019
- Completion Date
- 13-Nov-2018
Overview
EN ISO 20569:2018 - Dentistry - Trephine burs (ISO 20569:2018) specifies requirements and test methods for dental trephine burs used primarily in oral implantology for collecting bone cores and removing implants. Published by CEN/ISO, the standard covers design classification, material selection, dimensional tolerances, performance tests, and requirements for marking, labelling and instructions for use. It helps manufacturers, test laboratories and dental clinics ensure safety, interchangeability and reprocessing compatibility of trephine burs.
Key Topics and Requirements
- Scope and classification
- Defines two types: Type 1 (for bone collection) and Type 2 (for implant removal).
- Materials
- Metals shall comply with ISO 7153-1 and ISO 13504 (surgical/dental instrument material requirements).
- Dimensions and tolerances
- Type 1 outer working-part diameter (D1): 2 mm to 16 mm.
- Type 2 inner working-part diameter (D2): 2 mm to 15 mm.
- Manufacturer’s stated values must be within ±0.05 mm (measured per clause 6.2).
- Wall thickness is manufacturer-defined but must withstand specified torque.
- Mechanical performance
- Resistance to torque: trephine burs must withstand 80 N·cm (test method in clause 6.6).
- Tests include Vickers hardness, run-out, and resistance to reprocessing.
- Surface, marking and labelling
- Surface finish: free of visible defects (visual inspection per clause 6.1).
- Marking lines, shank dimensions and package labelling are specified; instructions for reprocessing must follow ISO 17664.
- Test methods
- Referenced test methods include ISO 8325 (rotary instruments) and ISO 6507-1 (Vickers hardness) among others.
Applications and Who Uses This Standard
- Practical uses:
- Standardizes trephine burs used for bone harvesting, implant removal, and other implantology procedures.
- Ensures devices are dimensionally accurate, mechanically safe and reprocessable.
- Primary users:
- Manufacturers designing and certifying trephine burs.
- Quality and testing laboratories performing conformity tests (hardness, run-out, torque).
- Regulatory bodies and procurement teams assessing device compliance.
- Dental surgeons and clinics seeking validated instruments and processing instructions.
- Sterilization/reprocessing personnel relying on manufacturer-provided processing data.
Related Standards
- ISO 1797 - Shanks for rotary/oscillating instruments
- ISO 7153-1 - Surgical instruments - Materials (metals)
- ISO 8325 - Test methods for rotary instruments
- ISO 17664 - Processing information for medical devices
- ISO 6507-1 - Vickers hardness test
- ISO 13504, ISO 16443, ISO 1942 - dental vocabulary and implant-system terms
Keywords: EN ISO 20569:2018, ISO 20569, trephine burs, dentistry, oral implantology, bone collection, implant removal, dental instrument standards, marking and labelling.
Frequently Asked Questions
SIST EN ISO 20569:2018 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Trephine burs (ISO 20569:2018)". This standard covers: This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.
This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.
SIST EN ISO 20569:2018 is classified under the following ICS (International Classification for Standards) categories: 11.060.20 - Dental equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 20569:2018 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2018
Zobozdravstvo - Svedri za trepaniranje (ISO 20569:2018)
Dentistry - Trephine burs (ISO 20569:2018)
Zahnheilkunde - Trephinbohrer (ISO 20569:2018)
Medecine bucco-dentaire - Fraises-trépans (ISO 20569:2018)
Ta slovenski standard je istoveten z: EN ISO 20569:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20569
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Trephine burs (ISO 20569:2018)
Medecine bucco-dentaire - Fraises-trépans (ISO Zahnheilkunde - Trepanbohrer (ISO 20569:2018)
20569:2018)
This European Standard was approved by CEN on 10 August 2018.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20569:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20569:2018) 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 April 2019, and conflicting national standards shall be
withdrawn at the latest by April 2019.
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.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20569:2018 has been approved by CEN as EN ISO 20569:2018 without any modification.
INTERNATIONAL ISO
STANDARD 20569
First edition
2018-09
Dentistry — Trephine burs
Médecine bucco-dentaire — Fraises-trépans
Reference number
ISO 20569:2018(E)
©
ISO 2018
ISO 20569:2018(E)
© ISO 2018
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.
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Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 20569:2018(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 . 2
4 Classifications . 2
5 Requirements . 3
5.1 Selection of metals . 3
5.2 Surface finish . 3
5.3 Dimensions . 3
5.3.1 Number of teeth . . 3
5.3.2 Diameter of the working part and wall thickness . 3
5.3.3 Length of the operative part . 4
5.3.4 Overall length . . 4
5.3.5 Dimensions of the shank . 4
5.4 Marking lines on the operative part . 4
5.4.1 General. 4
5.4.2 Thickness of scale line . . 4
5.5 Resistance to reprocessing . 4
5.6 Vickers hardness . 4
5.7 Run-out . 4
5.8 Resistance to torque . 5
6 Measurement and test methods . 5
6.1 Visual inspection . 5
6.2 Dimensions and number of teeth . 5
6.3 Resistance to reprocessing . 5
6.4 Vickers hardness . 6
6.5 Run-out . 6
6.6 Resistance to torque . 6
7 Marking, labelling and instructions for use . 6
7.1 Marking on the trephine bur . 6
7.2 Labelling on the package . 6
7.3 Instructions for use . 6
Bibliography . 7
ISO 20569:2018(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
com
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