EN ISO 19715:2017
(Main)Dentistry - Filling instrument with contra angle (ISO 19715:2017)
Dentistry - Filling instrument with contra angle (ISO 19715:2017)
ISO 19715:2017 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.
Zahnheilkunde - Füllinstrumente mit Kontrawinkel (ISO 19715:2017)
Dieses Dokument legt Anforderungen und Prüfverfahren für ein Füllinstrument mit Kontrawinkel fest, das für die Restauration von Zähnen durch die Applikation von Füllungswerkstoffen auf Kunststoffbasis und Zementen verwendet wird. Es legt auch Anforderungen an die Konstruktion, Maße und Kennzeichnung fest.
Médecine bucco-dentaire - Instrument d'obturation à double angulation (ISO 19715:2017)
ISO 19715:2017 spécifie les exigences et méthodes d'essai relatives aux instruments d'obturation à double angulation et qui sont utilisés dans le cadre de restaurations dentaires réalisées par application de produits de restauration à base de polymères et ciments. Il spécifie également des exigences relatives à leur conception, leurs dimensions et leur marquage.
Zobozdravstvo - Instrumenti za polnjenje (ISO 19715:2017)
Ta mednarodni standard določa zahteve in povezane preskusne metode za instrumente za polnjenje z delovnimi konci s proti-naborom, ki se uporabljajo za obnovo zobovja s plastičnimi polnilnimi materiali. Določa tudi zahteve za zasnovo, dimenzije in označevanje.
General Information
Overview
EN ISO 19715:2017 - Dentistry - Filling instrument with contra angle defines requirements and test methods for hand-held dental filling instruments designed with a contra angle to apply and shape polymer-based restorative materials and cements. The standard covers design, classification, dimensions, materials, surface finish, marking and resistance to reprocessing, supporting consistent safety, performance and reusability across dental practice and manufacturing.
Key topics and technical requirements
- Scope & purpose: Requirements and test methods for filling instruments with a contra angle used in tooth restoration with polymer-based restorative materials and cements.
- Classification: Working ends are classified into five types (A–E): Ball, Pear, Plane plugger, Spatula (edge), Spatula (surface/beaver tail).
- Dimensions: Recommended overall geometry (example bend angles α = 135°, β = 90°) and detailed working-end sizes. Example diameters:
- Type A (Ball): 0.8–3.5 mm
- Type B (Pear): 0.8–2.5 mm
- Type C (Plane plugger): 0.8–2.5 mm
- Type D/E (Spatula): 1.0–3.2 mm
- Materials & hardness: Material selection is at the manufacturer’s discretion; stainless steel examples in ISO 7153‑1 are referenced. If stainless steel is used, hardness shall be 42 HRC to 60 HRC (tested per ISO 6507-1 / ISO 6508-1).
- Surface finish: Working ends shall be polished to a surface roughness Ra ≤ 0.4 µm; surfaces must be free of defects. Coatings to improve lubricity or contrast are permitted.
- Reprocessing resistance: Instruments must withstand 100 reprocessing cycles (cleaning, disinfection and, if recommended, sterilization) per manufacturer instruction and ISO 17664 without visible distortion, corrosion or performance loss. Exceptions apply for single‑use or manufacturer‑limited cycles.
- Marking & designation: Requirements for marking and for combining working ends are specified (see Annex A).
Applications and users
- Dental instrument manufacturers - for product design, quality control and compliance.
- Dental clinics and procurement teams - to select instruments meeting standardized dimensions, sterilization resilience and ergonomic contra-angle design.
- Sterilization/central service departments (CSSD) - to validate reprocessing procedures and cycles against ISO 17664.
- Regulatory and conformity assessment bodies - for device classification, labeling and market access in CEN/ISO markets.
Related standards
- ISO 17664 - sterilization information for reprocessable medical devices
- ISO 1942 - dentistry vocabulary
- ISO 6507‑1 / ISO 6508‑1 - hardness test methods (Vickers / Rockwell)
- ISO 7153‑1 - examples of suitable stainless steels (referenced)
Keywords: EN ISO 19715:2017, filling instrument with contra angle, dental instruments, polymer-based restorative materials, sterilization, reprocessing, working end types, surface roughness, hardness.
Frequently Asked Questions
EN ISO 19715:2017 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Filling instrument with contra angle (ISO 19715:2017)". This standard covers: ISO 19715:2017 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.
ISO 19715:2017 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.
EN ISO 19715:2017 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.
You can purchase EN ISO 19715:2017 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
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
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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.
...
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