prEN ISO 18397
(Main)Dentistry - Powered scaler (ISO/DIS 18397:2024)
Dentistry - Powered scaler (ISO/DIS 18397:2024)
ISO 18397:2016 specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.
Zahnheilkunde - Angetriebener Scaler (ISO/DIS 18397:2024)
Médecine bucco-dentaire - Instruments pour détartrage (ISO/DIS 18397:2024)
ISO 18397:2016 spécifie les exigences et les méthodes d'essai pour les pièces à main et les parties actives des instruments pour détartrage électriques et actionnés par air comprimé, notamment les instruments à ultrasons de type piézoélectrique, ferrostrictif et magnétostrictif, utilisées de manière autonome ou reliées à des units dentaires, en vue d'une utilisation sur des patients. Elle contient également des spécifications relatives aux instructions du fabricant, au marquage et à l'emballage.
Zobozdravstvo - Pripomočki za čiščenje (scaler) (ISO/DIS 18397:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 18397:2016
Zobozdravstvo - Pripomočki za čiščenje (scaler) (ISO/DIS 18397:2024)
Dentistry - Powered scaler (ISO/DIS 18397:2024)
Zahnheilkunde - Angetriebener Scaler (ISO/DIS 18397:2024)
Médecine bucco-dentaire - Instruments pour détartrage (ISO/DIS 18397:2024)
Ta slovenski standard je istoveten z: prEN ISO 18397
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18397
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2024-01-26 2024-04-19
Dentistry — Powered scaler
Médecine bucco-dentaire — Instruments pour le détartrage
ICS: 11.060.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18397:2024(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2024
ISO/DIS 18397:2024(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18397
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
Dentistry — Powered scaler
Médecine bucco-dentaire — Instruments pour le détartrage
ICS: 11.060.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2024
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 18397:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 18397:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification of scaler handpieces .3
5 Requirements and performance .3
5.1 General . 3
5.2 Materials . 3
5.3 Drop test . 3
5.4 Noise level . 3
5.5 Surfaces . 3
5.6 Electrical power supply . 4
5.7 Energy for light source . 4
5.8 Air supply . 4
5.9 Supply of cooling liquid . 4
5.10 Air and water pressure . 4
5.11 Temperature . 4
5.11.1 Temperature rise of housing . 4
5.11.2 Temperature, excessive . 4
5.12 Vibrations . 5
5.13 Resistance to reprocessing . 5
5.14 Leakage and/or ingress of water . 5
5.15 Electromagnetic compatibility. 5
5.16 Operating controls . 5
5.17 Usability . 5
5.18 Connection . 5
5.18.1 General . 5
5.18.2 Connections for air-powered scaler handpieces . 6
5.18.3 Connector for electrical-powered scaler handpieces . 6
5.19 Scaler tip performance . 6
5.19.1 Scaler tip connection . 6
5.19.2 Extraction force. 6
5.19.3 Holding torque . 6
5.19.4 Insertion force . 6
5.19.5 Tightening torque . 6
5.19.6 Stall effort . 7
5.19.7 Power output, scaler tips . 7
5.19.8 Breakage resistance . 7
5.20 Frequency . 7
5.21 Amplitude . 7
6 Sampling . 7
7 Testing. 7
7.1 General test conditions . 7
7.2 Visual inspection . 7
7.3 Power supply — Electrical . 7
7.4 Air supply . 8
7.4.1 Apparatus . 8
7.4.2 Procedure . 8
7.5 Supply of cooling liquid . 8
7.5.1 Apparatus . 8
7.5.2 Procedure . 8
iii
ISO/DIS 18397:2023(E)
7.6 Air and water pressure . 8
7.6.1 Apparatus . 8
7.6.2 Procedure . 8
7.7 Measuring device for dimensions .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.