SIST EN ISO 19490:2017

Dentistry - Sinus membrane elevator (ISO 19490:2017)

This International Standard specifies requirements and their test methods for sinus elevator used in dentistry especially for lateral approach of sinus floor elevation. It also specifies the requirements for their marking and labelling.

Zahnheilkunde - Sinusmembranelevatoren (ISO 19490:2017)

Dieses Dokument legt Anforderungen und ihre Prüfverfahren für Sinusmembranelevatoren, die in der dentalen Implantologie zur Sinusbodenanhebung verwendet werden, fest. Sie beschreibt auch die Anforderungen an ihre Markierung und Kennzeichnung.

Médecine bucco-dentaire — Sinus membrane élevateurs (ISO 19490:2017)

L'ISO 19490:2017 spécifie les exigences et les méthodes d'essai relatives aux élévateurs de membrane sinusienne utilisés en implantologie dentaire pour relever le plancher sinusien. Il spécifie également les exigences relatives à leur marquage et étiquetage.

Zobozdravstvo - Sinusno membransko dvigalo (ISO 19490:2017)

Ta mednarodni standard določa zahteve in povezane preskusne metode za sinusno dvigalo, ki se uporablja v zobozdravstvu zlasti za lateralni pristop k sinusnemu dviganju dna. Določa tudi zahteve za označevanje in etiketiranje.

General Information

• Status: Published
• Public Enquiry End Date: 18-Aug-2016
• Publication Date: 15-Aug-2017
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 02-Aug-2017
• Due Date: 07-Oct-2017
• Completion Date: 16-Aug-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 19490:2017 - Dentistry - Sinus membrane elevator (ISO 19490:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 19490:2017
01-september-2017
Zobozdravstvo - Sinusno membransko dvigalo (ISO 19490:2017)
Dentistry - Sinus membrane elevator (ISO 19490:2017)
Zahnheilkunde - Sinusmembranelevatoren (ISO 19490:2017)
0pGHFLQHEXFFRGHQWDLUH6LQXVPHPEUDQHpOHYDWHXUV,62
Ta slovenski standard je istoveten z: EN ISO 19490:2017
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 19490:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19490:2017

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SIST EN ISO 19490:2017


EN ISO 19490
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2017
EUROPÄISCHE NORM
ICS 11.060.25
English Version

Dentistry - Sinus membrane elevator (ISO 19490:2017)
Médecine bucco-dentaire - Sinus membrane élevateurs Zahnheilkunde - Sinusmembranelevator (ISO
(ISO 19490:2017) 19490:2017)
This European Standard was approved by CEN on 18 May 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 19490:2017 E
worldwide for CEN national Members.

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SIST EN ISO 19490:2017
EN ISO 19490:2017 (E)
Contents Page
European foreword . 3

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SIST EN ISO 19490:2017
EN ISO 19490:2017 (E)
European foreword
This document (EN ISO 19490:2017) 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 December 2017, and conflicting national standards
shall be withdrawn at the latest by December 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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 19490:2017 has been approved by CEN as EN ISO 19490:2017 without any modification.
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SIST EN ISO 19490:2017

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SIST EN ISO 19490:2017
INTERNATIONAL ISO
STANDARD 19490
First edition
2017-06
Dentistry — Sinus membrane elevator
Médecine bucco-dentaire — Sinus membrane élevateurs
Reference number
ISO 19490:2017(E)
©
ISO 2017

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SIST EN ISO 19490:2017
ISO 19490:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 19490:2017
ISO 19490:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 Material of the working end . 2
5.2 Material for the handle. 2
5.3 Dimensions . 2
5.4 Surface finish . 2
5.5 Resistance to reprocessing . 2
5.6 Hardness of the working end . 2
5.7 Connection of shank and handle. 2
5.8 Shape of working end . 2
6 Test method . 4
6.1 Measurement of length . 4
6.2 Test on surface finish . 4
6.3 Test on resistance to reprocessing . 4
6.4 Hardness test . 4
6.5 Connection of shank and handle. 4
6.5.1 Test under tensile force . 4
6.5.2 Test under torque . 4
7 Marking .
...