EN 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
• Publication Date: 29-Sep-2015
• Withdrawal Date: 30-Mar-2016
• ICS: 11.060.01 - Dentistry in general
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Sep-2015
• Due Date: 03-Apr-2015
• Completion Date: 30-Sep-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 17937:2015 - Dentistry - Osteotome (ISO 17937:2015)

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
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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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 . 7
Bibliography . 8
ISO 17937:2015(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
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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
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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).
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For an explanation on the meaning of ISO specific terms and expressions rela
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