ISO 19490:2017
(Main)Dentistry - Sinus membrane elevator
Dentistry - Sinus membrane elevator
ISO 19490:2017 specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
Médecine bucco-dentaire — Élévateur de membrane sinusienne
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.
General Information
Relations
Overview
ISO 19490:2017 - Dentistry - Sinus membrane elevator specifies requirements and test methods for sinus membrane elevators used during dental implant procedures to lift the sinus floor (sinus floor lifting). The standard covers materials, dimensions, surface condition, hardness, reprocessing resistance, mechanical connection between the active end and handle, and requirements for marking, labelling and the instructions for use. It is intended to ensure safety, performance and traceability of these dental instruments.
Key topics and technical requirements
Scope and definitions
- Applies to hand instruments designed to elevate or displace the sinus membrane via lateral (external) or vertical (crestal) approaches.
- Defines components: active end (tip and shank/neck), tip (portion entering bone/membrane), and handle.
Classification
- Type 1: Lateral/vestibular/external approach
- Type 2: Vertical/crestal/internal approach
Materials
- Active end material shall comply with ISO 13504:2012 (requirements for dental implant instruments).
- Handle material is left to manufacturer discretion.
Dimensions and ergonomics
- Overall length is at manufacturer’s discretion; note that lengths >178 mm may create reprocessing/storage difficulties.
Surface and reprocessing
- Instruments must be free from visible surface defects on visual inspection.
- Must withstand 100 reprocessing cycles (cleaning, disinfection, sterilization) as per manufacturer instructions without corrosion or deterioration.
Hardness
- Active end hardness: ≥ 480 HV1 (Vickers) or ≥ 48 HRC (Rockwell). Testing per ISO 6507-1 or ISO 6508-1.
Mechanical integrity
- Connection between shank and handle must not develop play after mechanical tests:
- Tensile test: 1 000 N applied for 5 s (per ISO 15087-1 Annex C).
- Torsion test: 500 N·cm applied for 5 s (per ISO 15087-1 Annex D).
- Connection between shank and handle must not develop play after mechanical tests:
Marking, labelling and IFU
- Instrument marking and packaging labelling must follow ISO 13504:2012 requirements.
- Instructions for use must include detailed reprocessing methods (cleaning, disinfection, sterilization), with reference to ISO 17664 where applicable.
Applications and users
- Primary users: dental instrument manufacturers, regulatory compliance teams, quality managers, and dental clinics purchasing or validating sinus membrane elevators.
- Practical uses:
- Product design and validation to meet recognized international performance and safety criteria.
- Supplier selection and incoming inspection for dental practices and dental device distributors.
- Regulatory submissions and CE/market compliance documentation.
Related standards
- ISO 13504:2012 - general requirements for implantology instruments
- ISO 15087-1 - dental elevators (test methods referenced)
- ISO 6507-1 / ISO 6508-1 - hardness testing (Vickers / Rockwell)
- ISO 17664 - sterilization information for medical devices
Keywords: ISO 19490:2017, sinus membrane elevator, dentistry standard, dental implants, sinus floor lifting, test methods, hardness, reprocessing, marking and labelling.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 19490
First edition
2017-06
Dentistry — Sinus membrane elevator
Médecine bucco-dentaire — Sinus membrane élevateurs
Reference number
©
ISO 2017
© 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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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 . 4
7.1 Marking on the instrument . 4
7.2 Labelling on the package . 4
7.3 Instructions for use . 4
Bibliography . 5
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
...
NORME ISO
INTERNATIONALE 19490
Première édition
2017-06
Médecine bucco-dentaire — Élévateur
de membrane sinusienne
Dentistry — Sinus membrane elevator
Numéro de référence
©
ISO 2017
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2017, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Classification . 2
5 Exigences . 2
5.1 Matériau de l’extrémité active . 2
5.2 Matériau du manche . 2
5.3 Dimensions . 2
5.4 État de surface . 2
5.5 Résistance au retraitement . 2
5.6 Dureté de l’extrémité active . 2
5.7 Liaison de la queue et du manche . 2
5.8 Forme de l’extrémité active . 2
6 Méthode d’essai . 4
6.1 Mesurage de la longueur . 4
6.2 Essai d’état de surface . 4
6.3 Essai de résistance au retraitement . 4
6.4 Essai de dureté . 4
6.5 Raccordement de la queue et du manche . 4
6.5.1 Essai de traction . 4
6.5.2 Essai de torsion . 4
7 Marquage . 4
7.1 Marquage de l’instrument . 4
7.2 Étiquetage de l’emballage . 4
7.3 Notice d’utilisation . 4
Bibliographie . 5
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir http://
www .iso .org/ directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et
...
Frequently Asked Questions
ISO 19490:2017 is a standard published by the International Organization for Standardization (ISO). Its full title is "Dentistry - Sinus membrane elevator". This standard covers: ISO 19490:2017 specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
ISO 19490:2017 specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.
ISO 19490:2017 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.
ISO 19490:2017 has the following relationships with other standards: It is inter standard links to ISO 3233-2:2019, ISO 19490:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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