ISO 17509:2016
(Main)Dentistry — Torque transmitter for handpieces
Dentistry — Torque transmitter for handpieces
ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. ISO 17509:2016 does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.
Médecine bucco-dentaire — Transmetteur de couple pour pièces à main
ISO 17509:2016 fixe les exigences requises des transmetteurs de couple destinés à être utilisés en implantologie buccale conjointement avec une pièce à main dentaire, comme accessoire pour la pose des implants dentaires et pour les manipulations ultérieures des éléments de connexion dans la région cranio-faciale. ISO 17509:2016 est applicable aux transmetteurs de couple utilisés pour la pose ou le retrait d'implants dans la cavité buccale du patient, raccordés à des systèmes commandés par un moteur munis d'un mécanisme de contrôle du couple, mais elle n'est pas applicable auxdits systèmes eux-mêmes. ISO 17509:2016 ne traite ni de l'implant dentaire, ni des éléments qui viennent s'y raccorder. En ce qui concerne la sécurité, la présente Norme internationale fixe des exigences relatives à la classification, aux performances prévues, aux caractéristiques de performance, au choix des matériaux, à l'évaluation de la performance, à la fabrication, au retraitement et aux informations à fournir par le fabricant.
General Information
- Status
- Published
- Publication Date
- 29-Sep-2016
- Technical Committee
- ISO/TC 106/SC 4 - Dental instruments
- Drafting Committee
- ISO/TC 106/SC 4/WG 13 - Implant instruments
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 11-Mar-2022
- Completion Date
- 14-Feb-2026
Relations
- Effective Date
- 12-Feb-2026
Overview - ISO 17509:2016 (Dentistry - Torque transmitter for handpieces)
ISO 17509:2016 specifies safety and performance requirements for torque transmitters (screw bits) used with dental handpieces in oral implantology. The standard covers torque transmitters that connect to power‑driven systems with torque control mechanisms for placement and removal of implants or connecting parts in the craniofacial area. It does not apply to the power‑driven systems themselves, the implants, or implant parts. Key areas addressed include classification, intended performance, materials, manufacture, reprocessing and the information manufacturers must supply.
Key topics and technical requirements
Scope & classification
- Applies to torque transmitters used in the oral cavity and connected to powered systems.
- Classified per ISO 13504: Type 1 (energized/motor driven), Tissue contact Class 2 (soft tissue), Reprocessing Group 1 (multiple use).
Intended performance & attributes
- Designed to transmit rotary movement safely and reliably without visible disturbance.
- Minimum transmitted torque for insertion: at least 1.0 N·m (for implant insertion - technical limit, not a clinical recommendation).
- Shank dimensions shall conform to ISO 1797‑1 (Type 1 shank); head shape is manufacturer‑defined.
- Surface roughness requirements referenced to ISO 3274 / ISO 4288 as shown in the standard.
Material & hardness
- Materials selected per Annex A of ISO 13504.
- For steel shanks, hardness shall be not less than 500 HV5 (Vickers).
Testing & verification
- Visual inspection of product documentation and physical parts.
- Torque testing apparatus: chuck per ISO 1797‑1, a non‑contacting tachometer (±5% accuracy), and a torque watch/dynamometer (±10% accuracy).
- Procedure: fix the transmitter in the chuck, connect torque measuring device, rotate and record maximum torque.
Manufacture, reprocessing & information
- Manufacturing, reprocessing and performance evaluation requirements reference ISO 13504 and IEC 62366 (usability engineering).
- Manufacturers must supply specified labeling, instructions and test data.
Applications and practical value
- Ensures safe design and consistent torque transmission during implant placement and removal.
- Used by manufacturers to design, qualify and label torque transmitters for dental handpieces.
- Guides test laboratories and quality/ regulatory teams in product verification and conformity assessment.
- Helps dental clinics and procurement to evaluate device specifications and reprocessing instructions.
Who should use this standard
- Dental device manufacturers and product designers
- Test laboratories and conformity assessors
- Regulatory and quality managers in medical devices
- Dental clinics and purchasing professionals assessing instrument compatibility
Related standards
- ISO 13504 (general requirements for implant instruments)
- ISO 1797‑1 (shank dimensions)
- ISO 3274, ISO 4288 (surface texture)
- ISO 6507‑1 (Vickers hardness test)
- ISO 1942, ISO 16443 (vocabulary)
- IEC 62366 (usability engineering)
Keywords: ISO 17509:2016, torque transmitter, dental handpiece, oral implantology, torque measurement, dental implant instruments, reprocessing, ISO 13504.
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ISO 17509:2016 - Dentistry -- Torque transmitter for handpieces
ISO 17509:2016 - Médecine bucco-dentaire -- Transmetteur de couple pour pièces à main
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Frequently Asked Questions
ISO 17509:2016 is a standard published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Torque transmitter for handpieces". This standard covers: ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. ISO 17509:2016 does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.
ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. ISO 17509:2016 does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.
ISO 17509:2016 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.
ISO 17509:2016 has the following relationships with other standards: It is inter standard links to EN ISO 17509:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 17509:2016 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)
INTERNATIONAL ISO
STANDARD 17509
First edition
2016-10-01
Dentistry — Torque transmitter for
handpieces
Médecine bucco-dentaire — Transmetteur de couple pour pièces à main
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Intended performance . 2
6 Performance attributes . 2
6.1 Dimensions . 2
6.2 Performance . 2
6.3 Material selection . 2
7 Performance evaluation . 4
8 Manufacturing . 4
9 Resistance to reprocessing . 4
10 Information to be supplied by the manufacturer . 4
11 Testing . 4
11.1 Inspection of technical product file . 4
11.2 Dimensions . 4
11.3 Stall torque . 5
11.3.1 Apparatus . 5
11.3.2 Procedure . 5
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
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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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
iv © ISO 2016 – All rights reserved
Introduction
Based on ISO 13504, this International Standard
...
NORME ISO
INTERNATIONALE 17509
Première édition
2016-10-01
Médecine bucco-dentaire —
Transmetteur de couple pour pièces à
main
Dentistry — Torque transmitter for handpieces
Numéro de référence
©
ISO 2016
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Classification . 2
5 Performances prévues . 2
6 Caractéristiques de performance . 2
6.1 Dimensions . 2
6.2 Performances . 2
6.3 Choix des matériaux . 3
7 Évaluation de la performance . 4
8 Fabrication . 4
9 Résistance au retraitement . 4
10 Informations à fournir par le fabricant . 4
11 Essais . 5
11.1 Contrôle des caractéristiques techniques du produit . 5
11.2 Dimensions . 5
11.3 Couple maximal . 5
11.3.1 Appareillage . 5
11.3.2 Mode opératoire . 5
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
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concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
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l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
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Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à
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de l’OMC concernant les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos —
Informations supplémentaires.
Le comité chargé de l’élaboration du présent document est l’ISO/TC 106, Médecine bucco-dentaire, Sous-
comité SC 4, Instruments dentaires.
iv © ISO 2016 – Tous droits réservés
Introduction
Basée sur l’ISO 13504, la présente Norme internationale décrit les accessoires qui sont insérés dans
les pièces à main dentaires et qui transmettent des forces de rotation de la pièce à main aux implants
dentaires ou à leurs éléments de connexion.
NORME INTERNATIONALE ISO 17509:2016(F)
Médecine bucco-dentaire — Transmetteur de couple pour
pièces à main
...
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