EN ISO 17509:2016
(Main)Dentistry - Torque transmitter for handpieces (ISO 17509:2016)
General Information
- Abstract
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.
- Status
- Published
- Publication Date
- 25-Oct-2016
- Withdrawal Date
- 29-Apr-2017
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 26-Oct-2016
- Due Date
- 01-Jan-2017
- Completion Date
- 26-Oct-2016
- Directive
- Not Harmonized93/42/EEC - Medical devices
Overview
EN ISO 17509:2016 - "Dentistry - Torque transmitter for handpieces (ISO 17509:2016)" specifies safety and performance requirements for torque transmitters used in oral implantology as accessories to dental handpieces. The standard covers classification, intended performance, material selection, dimensions, performance evaluation, manufacture, reprocessing resistance and the information manufacturers must supply. It applies to torque transmitters used for placement and removal in the oral cavity that connect to power‑driven systems with torque control, but it does not apply to the power‑driven systems themselves nor to dental implants or implant parts.
Key Topics and Requirements
- Scope & exclusions: Applies only to torque transmitters (accessories), not to implants or the power-driven handpiece systems.
- Classification: Aligned with ISO 13504 - Type 1 (energized/motor‑driven), Tissue contact Class 3 (without tissue contact), Reprocessing Group 1 (multiple use).
- Dimensions and interfacing:
- Shank dimensions and tolerances must follow ISO 1797‑1 Type 1 shank.
- Manufacturers must label the shape and dimensions of the engaging part that fits implant bodies or connecting parts.
- Performance:
- Torque transmitters shall transmit at least 0.8 N·m for implant insertion.
- Stall torque testing procedures and apparatus are defined (chuck per ISO 1797‑1; torque measuring device with accuracy ±10%).
- Materials & hardness:
- Material selection per ISO 13504 requirements; steel shanks hardness ≥ 500 HV5 (Vickers).
- Reprocessing:
- Multiple‑use instruments must withstand 100 reprocessing cycles (cleaning, disinfection, sterilization) without performance loss or corrosion.
- Manufacturer information:
- Product marking (manufacturer/trademark) and technical data in the product file; instructions for use and reprocessing guidance required.
- Usability & safety: Usability engineering per IEC 62366‑1 and general dental instrument requirements from ISO 13504.
Applications and Who Uses It
- Dental device manufacturers designing torque transmitters and handpiece accessories for oral implantology.
- Quality, regulatory and design engineers ensuring compliance with EU/CEN and ISO requirements for dental accessories.
- Clinical procurement and sterilization teams verifying reprocessing compatibility and labeling.
- Test labs and conformity assessors performing dimensional, hardness and stall torque testing.
This standard is essential for ensuring reliable torque transmission, device compatibility with implant interfaces, and safe reprocessing practices in dental implant procedures.
Related Standards
- ISO 13504 (general dental implant instrument requirements)
- ISO 1797‑1 (shank dimensions)
- ISO 6507‑1 (Vickers hardness test)
- IEC 62366‑1 (usability engineering)
- ISO 16443, ISO 3274, ISO 4288 (referenced for vocabulary and surface texture)
Relations
- Refers
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices - Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 12-Feb-2026
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Frequently Asked Questions
EN ISO 17509:2016 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Torque transmitter for handpieces (ISO 17509:2016)". 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.
EN ISO 17509:2016 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 17509:2016 has the following relationships with other standards: It is inter standard links to IEC 62366-1:2015, ISO 3274:1996, ISO 6507-1:2005, ISO 4288:1996, ISO 1942:2009, ISO 10664:2014, ISO 1797-1:2011, ISO 13504:2012, ISO 16443:2014, EN 474-5:2006+A1:2009+A2:2012, EN 139:1994, EN ISP 10613-5:1996, EN 14458:2004, ISO 17509:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 17509:2016 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 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)
SLOVENSKI STANDARD
01-januar-2017
=RER]GUDYVWYR3UHQRVQLNQDYRUD]DURþQHSULSRPRþNH ,62
Dentistry - Torque transmitter for handpieces (ISO 17509:2016)
Zahnheilkunde - Drehmomentübertragungsschaft für Chirurgiewinkelstücke (ISO
17509:2016)
Médecine bucco-dentaire - Transmetteur de couple pour pièces à main (ISO
17509:2016)
Ta slovenski standard je istoveten z: EN ISO 17509:2016
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17509
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Torque transmitter for handpieces (ISO
17509:2016)
Médecine bucco-dentaire - Transmetteur de couple Zahnheilkunde - Drehmomentübertragungsschaft für
pour pièces à main (ISO 17509:2016) Chirurgiewinkelstücke (ISO 17509:2016)
This European Standard was approved by CEN on 3 September 2016.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17509:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 17509:2016) 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 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] 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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 17509:2016 has been approved by CEN as EN ISO 17509:2016 without any modification.
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 17509:2016(E)
©
ISO 2016
ISO 17509:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved
ISO 17509:2016(E)
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
...