SIST EN ISO 17937:2015
(Main)Dentistry - Osteotome (ISO 17937:2015)
Dentistry - Osteotome (ISO 17937:2015)
ISO 17937:2015 specifies requirements and their test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.
Zahnheilkunde - Osteotome (ISO 17937:2015)
Médecine bucco-dentaire - Ostéotome (ISO 17937:2015)
ISO 17937:2015 spécifie les exigences et les méthodes d'essai relatives aux ostéotomes utilisés en médecine bucco-dentaire pour le compactage osseux, l'élévation du plancher du sinus interne et pour fendre la mâchoire. Elle spécifie également les exigences relatives à leur marquage et étiquetage.
Zobozdravstvo - Osteotom (ISO 17937:2015)
Ta standard določa zahteve glede oblike in dimenzij ter preskusne metode za osteotome. Osteotomi se uporabljajo v zobozdravstvu na področju implantologije za ročno pripravo podlage implantata, npr. zgostitev kosti in dvig sinusnega dna. Na rastočem področju implantologije so se pojavile potrebe po standardiziranih instrumentih.
General Information
- Status
- Published
- Public Enquiry End Date
- 09-Jul-2014
- Publication Date
- 02-Nov-2015
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 08-Oct-2015
- Due Date
- 13-Dec-2015
- Completion Date
- 03-Nov-2015
Overview
EN ISO 17937:2015 - Dentistry - Osteotome is the CEN-adopted European version of ISO 17937:2015. It specifies requirements and test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving, and covers marking, labelling and instructions for use. The standard addresses three instrument types-sinutome, condenser, and chisel-and defines working-end shapes, shank forms, materials, and performance tests.
Key topics and requirements
- Scope and classification
- Defines osteotomes for dental implant site preparation and classifies them by type (sinutome, condenser, chisel) and shank form (straight or offset).
- Shapes and dimensions
- Specifies acceptable working tip shapes (e.g., cylindrical for sinutomes, conical for condensers) and dimensional characteristics of the working end and overall length.
- Materials
- Addresses acceptable materials for working ends and handles, consistent with dental-instrument requirements.
- Performance requirements and test methods
- Surface finish evaluation and resistance to reprocessing (sterilization cycles).
- Hardness testing referencing ISO 6507-1 (Vickers) and ISO 6508-1 (Rockwell).
- Connection tests for shank-to-handle integrity, including tensile and torque tests.
- Measurement tests for length and diameter of the working area.
- Marking, labelling and instructions
- Requirements for marking on the instrument, package labelling, and user instructions to ensure traceability and safe clinical use.
- Normative references
- Integrates terminology and cross-references from related standards such as ISO 1942, ISO 13504, ISO 15087-1 and ISO 16443.
Applications and practical value
- Ensures consistent dimensions and mechanical performance of osteotomes used in dental implantology, sinus lifts and bone-splitting procedures.
- Guides manufacturers in design, testing and labelling to meet regulatory and clinical expectations for safety, durability and reprocessing compatibility.
- Helps dental clinics and procurement teams select instruments that meet recognized instrument standards for reliable clinical outcomes and infection control.
- Supports quality managers and conformity assessors in demonstrating compliance during audits and product approvals.
Who should use this standard
- Dental instrument manufacturers (design, production, QA)
- Regulatory and conformity bodies
- Clinical managers, sterilization departments and procurement teams
- Dental implant and oral surgery specialists seeking standardized instrument specifications
Related standards
- ISO 1942 (Dentistry - Vocabulary)
- ISO 6507-1, ISO 6508-1 (Hardness tests)
- ISO 13504, ISO 15087-1, ISO 16443
Keywords: EN ISO 17937:2015, osteotome, dentistry, sinutome, condenser, chisel, sinus floor elevation, bone compaction, dental instrument standards, marking and labelling, hardness test, surface finish, reprocessing resistance.
Frequently Asked Questions
SIST EN ISO 17937:2015 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Osteotome (ISO 17937:2015)". This standard covers: ISO 17937:2015 specifies requirements and their test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.
ISO 17937:2015 specifies requirements and their test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.
SIST EN ISO 17937:2015 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 17937:2015 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.
SIST EN ISO 17937:2015 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-2015
Zobozdravstvo - Osteotom (ISO 17937:2015)
Dentistry - Osteotome (ISO 17937:2015)
Zahnheilkunde - Osteotome (ISO 17937:2015)
Médecine bucco-dentaire - Ostéotome (ISO 17937:2015)
Ta slovenski standard je istoveten z: EN ISO 17937:2015
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17937
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.060.01
English Version
Dentistry - Osteotome (ISO 17937:2015)
Médecine bucco-dentaire - Ostéotome (ISO Zahnheilkunde - Osteotome (ISO 17937:2015)
17937:2015)
This European Standard was approved by CEN on 22 August 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17937:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 17937:2015) 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 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
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 17937:2015 has been approved by CEN as EN ISO 17937:2015 without any modification.
INTERNATIONAL ISO
STANDARD 17937
First edition
2015-09-15
Dentistry — Osteotome
Médecine bucco-dentaire — Ostéotome
Reference number
ISO 17937:2015(E)
©
ISO 2015
ISO 17937:2015(E)
© ISO 2015, 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
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ii © ISO 2015 – All rights reserved
ISO 17937:2015(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 Classification . 2
5 Shapes . 2
5.1 Sinutome . 2
5.2 Condenser . 3
5.3 Chisel . 4
6 Material . 5
6.1 Material of the working end . 5
6.2 Material for the handle. 5
7 Requirements . 5
7.1 Dimensions . 5
7.1.1 Diameter of the working end (D , D ) . . 5
1 2
7.1.2 Overall length . . 5
7.2 Marking on the working end . 6
7.2.1 General. 6
7.2.2 Thickness of scale line . . 6
7.3 Surface finish . 6
7.4 Resistance to reprocessing . 6
7.5 Hardness of the working end . 6
7.6 Connection of shank and handle. 6
8 Test method . 6
8.1 Measurement of length and diameter . 6
8.2 Test on surface finish . 6
8.3 Test on resistance to reprocessing . 6
8.4 Hardness test . 6
8.5 Connection of shank . 7
8.5.1 Test under tensile force . 7
8.5.2 Test under torque . 7
9 Marking, labelling, and instructions for use . 7
9.1 Marking on the osteotome . 7
9.2 Labelling on the package . 7
9.3 Instructions for use .
...




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