EN ISO 19715:2017

SLOVENSKI STANDARD
01-september-2017
Zobozdravstvo - Instrumenti za polnjenje (ISO 19715:2017)
Dentistry - Filling instrument with contra angle (ISO 19715:2017)
Zahnheilkunde - Füllinstrumente mit Kontrawinkel (ISO 19715:2017)
Médecine bucco-dentaire - Instrument d'obturation à double angulation (ISO
19715:2017)
Ta slovenski standard je istoveten z: EN ISO 19715:2017
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19715
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2017
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Filling instrument with contra angle (ISO
19715:2017)
Médecine bucco-dentaire - Instrument d'obturation à Zahnheilkunde - Füllinstrumente mit Kontrawinkel
double angulation (ISO 19715:2017) (ISO 19715:2017)
This European Standard was approved by CEN on 1 March 2017.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19715:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19715:2017) 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 November 2017 and conflicting national standards
shall be withdrawn at the latest by November 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 19715:2017 has been approved by CEN as EN ISO 19715:2017 without any modification.
INTERNATIONAL ISO
STANDARD 19715
First edition
2017-05
Dentistry — Filling instrument with
contra angle
Médecine bucco-dentaire — Instrument d’obturation à double
angulation
Reference number
ISO 19715:2017(E)
©
ISO 2017
ISO 19715:2017(E)
© ISO 2017, 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
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copyright@iso.org
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ii © ISO 2017 – All rights reserved

ISO 19715:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 4
5.1 Dimensions . 4
5.2 Dimensions of working end . 4
5.3 Materials . 5
5.4 Surface finish . 5
5.5 Handle. 5
5.6 Designation and combination of working ends . 5
5.7 Resistance to reprocessing . 5
6 Measurement and test methods . 6
6.1 Dimensions . 6
6.2 Hardness testing . 6
6.3 Surface roughness inspection . 6
6.4 Resistance to reprocessing test . 6
7 Marking . 6
Annex A (informative) Designation and combinations of working ends . 7
Bibliography . 9
ISO 19715:2017(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
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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 voluntary nature of standards, 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: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
iv © ISO 2017 – All rights reserved

ISO 19715:2017(E)
Introduction
In dentistry, corresponding to their intended use, filling instruments come into contact with the patient.
Consequently, special attention is to be given in respect to (re)processing.
Consideration of ergonomic aspects is also required. This is supported by the specific contra angle design.
INTERNATIONAL STANDARD ISO 19715:2017(E)
Dentistry — Filling instrument with contra angle
1 Scope
This document specifies requirements and test methods for a filling instrument with contra angle,
which is used for the restoration of teeth via the application of polymer-based restorative materials and
cements. It also specifies requirements for the design, dimensions and marking.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 6508-1, Metallic materials — Rockwell hardness test — Part 1: Test method
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
filling instrument
non-active hand-guided dental instrument for applying and modelling polymer-based restorative
materials and cements during dental restoration procedures
3.2
contra angle
angle of the second bend of the shank that connects the handle to the working end (3.4) and that
compensates the first bend so that the working end is in line with the axis of the shank
EXAMPLE See Figure 1.
3.3
filling instrument with contra angle
filling instrument (3.1), in which the working end (3.4) and the handle axis are on one axis and the shank
forms a contra angle (3.2)
EXAMPLE See Figure 1.
...