EN 61205:1994
(Main)Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics
Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics
Specifies: -essential non-thermal output characteristics of ultrasonic dental descalers; -the methods of measurement of the output performance of ultrasonic dental descalers; -the characteristics to be declared by the manufacturers of ultrasonic dental descalers.
Ultraschall - Zahnreinigersysteme - Messung und Deklaration der Ausgangskennwerte
Ultrasons - Systèmes de détartreurs dentaires - Mesure et déclaration des caractéristiques de sortie
Définit: les caractéristiques non thermiques essentielles, en sortie, des détartreurs dentaires ultrasoniques; les méthodes de mesure des performances en sortie des détartreurs dentaires ultrasoniques; les caractéristiques que les fabricants des détartreurs dentaires ont à déclarer.
Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics (IEC 61205:1993)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2002
Ultrasonics - Dental descaler systems - Measurement and declaration of the output
characteristics (IEC 61205:1993)
Ultrasonics - Dental descaler systems - Measurement and declaration of the output
characteristics
Ultraschall - Zahnreinigersysteme - Messung und Deklaration der Ausgangskennwerte
Ultrasons - Systèmes de détartreurs dentaires - Mesure et déclaration des
caractéristiques de sortie
Ta slovenski standard je istoveten z: EN 61205:1994
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
NORME CEI
IEC
INTERNATIONALE
INTERNATIONAL
Première édition
STANDARD
First edition
1993-12
Ultrasons - Systèmes de détartreurs dentaires -
Mesure et déclaration des caractéristiques
de sortie
Ultrasonics - Dental descaler systems -
Measurement and declaration of the
output characteristics
Droits de reproduction réservés — Copyright — all rights reserved
© CEI 1993
No part of this publication may be reproduced or utilized in
Aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun pro- any form or by any means, electronic or mechanical,
cédé, électronique ou mécanique, y compris la photocopie et including photocopying and microfilm, without permission
les microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher.
Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, Suisse
Commission Electrotechnique Internationale CODE PRIX
International Electrotechnical Commission
PRICE CODE P
IEC MetwayHapojHaa 3neHrporexHU4ecnaa KoMHccua
vigueur
Pour prix, voir catalogue en
•
For price, see current catalogue
1205 © I EC:1993 - 3 -
CONTENTS
Page
FOREWORD 5
INTRODUCTION
Clause
1 Scope 9
2 Normative reference 9
Definitions of output characteristics 9
4 11
List of symbols
General measuring conditions 11
5.1 Operating conditions
5.2 Load conditions
5.3 Cleaning of the apparatus
5.4 Irrigant temperature
6 Measurement procedures
6.1 Primary tip vibration excursion 11
6.2 Tip vibration frequency 13
6.3 Half-excursion force 15
7 Requirements for the declaration of essential output characteristics
Annexes
A General information about ultrasonic dental descalers (scalers)
B Guidance on the measurement methods 25
Figures 29
Bibliography
— 5 —
1205 ©IEC:1993
INTERNATIONAL ELECTROTECHNICAL COMMISSION
ULTRASONICS - DENTAL DESCALER SYSTEMS -
Measurement and declaration of the output characteristics
FOREWORD
The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
1)
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international cooperation on all questions concerning standardization in the electrical and
electronic fields. To this end and in addition to other activities, the IEC publishes International Standards.
Their preparation is entrusted to technical committees; any IEC National Committee interested in
the subject dealt with may participate in this preparatory work. International, governmental and
non-governmental organizations liaising with the IEC also participate in this preparation. The IEC
collaborates closely with the International Organization for Standardization (ISO) in accordance with
conditions determined by agreement between the two organizations.
The formal decisions or agreements of the IEC on technical matters, prepared by technical committees on
2)
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
They have the form of recommendations for international use published in the form of standards, technical
3)
reports or guides and they are accepted by the National Committees in that sense.
In order to promote international unification, IEC National Committees undertake to apply IEC International
4)
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
International Standard IEC 1205 has been prepared by IEC technical committee 87:
Ultrasonics.
The text of this standard is based on the following documents:
DIS Report on Voting
87(CO)32
87(CO)26
Full information on the voting for the approval of this standard can be found in the report
on voting indicated in the above table.
Annexes A and B are for information only.
1205 ©I EC:1993 - 7 -
INTRODUCTION
Ultrasonic dental descalers are widely used for removing plaque and calculus from teeth.
Although the mode of action of these devices has not been well characterized, the
cleaning efficiency of ultrasonic dental descalers depends on the vibration amplitude.
The purpose of this International Standard is to define standard methods of measurement
and specification of the essential vibration characteristics of ultrasonic dental descalers.
Questions of safety and biological effects of the output are not treated in this standard.
1205 ©IEC:1993 - 9 -
ULTRASONICS - DENTAL DESCALER SYSTEMS -
Measurement and declaration of the output characteristics
1 Scope
This International Standard specifies:
- essential non-thermal output characteristics of ultrasonic dental descalers;
-
methods of measurement of the output performance of ultrasonic dental descalers;
-
characteristics to be declared by the manufacturers of ultrasonic dental descalers.
2 Normative reference
The following normative reference contains provisions which, through reference in this
text, constitute provisions of this International Standard. At the time of publication, the
editions indicated were valid. All normative documents are subject to revision, and parties
to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent edition of the normative document listed below.
Members of IEC and ISO maintain registers of currently valid International Standards.
IEC 782: 1984, Measurements of ultrasonic magnetostrictive transducers
3 Definitions of output characteristics
For the purposes of this International Standard, the following definitions apply.
half-
3.1 excursion force: Force with which the tip must contact a glass slide so as to
reduce the primary tip vibration excursion to 50 % of the value it has when the contact
force is 0,15 N ± 0,02 N.
3.2 primary tip vibration excursion:
Peak-to-peak displacement of the applicator in the
direction of maximum amplitude, at a point on the applicator not more than 1 mm from its
tip.
tip vibration frequency: Fundamental frequency at which the tip of the applicator
3.3
oscillates.
1205 © IEC:1993
4 List of symbols
s Primary tip vibration excursion.
W o
Width of score marks on a glass slide with power off.
W Width of score marks on a glass slide with power on.
5 General measuring conditions
5.1 Operating conditions
Measurements shall be performed under parameters set to values recommended by the
manufacturer. The parameters to be considered are:
- ambient temperature;
- probe tip irrigant flow;
- driving frequency;
- output amplitude;
warm-up time.
Prior to making measurements, all controls associated with the ultrasonic dental descaler
shall be set to produce maximum vibration excursion.
5.2 Load conditions
Measurements shall be made with the applicator tip contacting a glass microscope slide.
The slide shall be lubricated with water (tap water is sufficient) and the standard contact
half-excursion
force shall be 0,15 N ± 0,02 N. For the purposes of the force measure-
ment (see 6.3), the method of applying the load shall be such that the load can be
gradually increased. To ensure accuracy of the measurement, the motion of the tip shall
be essentially perpendicular to the load. The force at the tip shall be known or measured.
5.3 Cleaning of the apparatus
All surfaces and parts of the applicator and of the measurement devices which come into
contact with water shall be cleaned, rinsed with warm water and dried in air.
5.4 lrrigant temperature
The irrigant shall emerge at a temperature between 30 °C and 40 °C or at the temperature
specified by the manufacturer (see clause 7).
6 Measurement procedures
6.1 Primary tip vibration excursion
primary tip vibration
One of the following methods shall be used for measuring the
excursion. The accuracy of the vibration excursion measurement shall be better than
±10% at 100 gm (see annex B for more details of the measurement methods). Reports of
1205 ©IEC:1993 - 13 -
measurements shall state clearly the load conditions and that the method satisfies the
requirements of this International Standard.
NOTE - The maximum primary tip vibration excursion is in the region of 100 p.m. At a constant drive
frequency, the operator may have control of this excursion.
6.1.1 Optical microscope method
A microscope shall be focused on a point on the applicator not more than 1,0 mm from its
tip. When the applicator is energised the point becomes a line. The relative orientations of
the tip and the microscope shall be altered until the maximum line length is observed. The
line length, equal to the primary tip vibration excursion, shall be measured by means of
the calibrated eyepiece reticule or micrometer. If other vibrations occur simultaneously,
then the point on the applicator describes an elliptical path and the maximum dimension of
the ellipse shall be measured. The maximum dimension of the ellipse shall be the
primary
tip vibration excursion.
6.1.2 Glass slide method
With the tip of the applicator in contact with the glass slide as specified in 5.2, the slide is
moved in a U-shaped raster under the applicator tip while the unit is switched on and off.
The measurement of the score mark should be made so as to ensure that the trace is
perpendicular to the direction of maximum tip vibration. The primary tip vibration excur-
sion, s, is given by:
s =(Wp- WQ)
where
W is the width of the score marks with the power on
W is the width of the score marks with the power off
6.2 Tip vibration frequency
One of the following methods shall be used to determine the tip vibration frequency. The
accuracy of frequency measurement shall be better than ±1 %. In some units, the operator
has manual control of the driving frequency and is able to adjust it to drive the applicator
at resonance, when the tip vibration amplitude is maximal; the tip vibration frequency
shall be measured when the manual frequency control is adjusted so that the tip vibration
displacement is maximal.
NOTE - For ultrasonic descaling equipment, the tip vibration frequency is in the range 18 000 Hz to
60 000 Hz.
6.2.1 Vibrometer method
A non-contacting vibrometer should be used (see annex B). The frequency of oscillation of
the tip shall be measured from the output of the vibrometer either using an electronic
frequency counter or an oscilloscope with a calibrated timebase.
6.2.2
Frequency counter method
An electronic frequency counter should be used to determine the frequency of the driving
voltage applied to the applicator.
1205 ©IEC:1993 - 15 -
6.3 Half-excursion force
During the procedure used to determine the primary tip vibration excursion (see 6.1.1
or 6.1.2), the force exerted by the tip on the microscope slide shall be increased until the
primary tip vibration excursion has been reduced to half of the value it has when the
force is 0,15 N ± 0,02 N (see annex B). The force shall then be determined.
NOTE - As the force on the applicator tip is increased, the primary tip vibration excursion reduces. The
force which reduces the excursion to half of the value it has under standard load conditions (0,15 N ± 0,02 N)
is an indicator of the energy available for work.
7 Requirements for the declaration of essential output characteristics
The manufacturer shall declare the following essential output characteristics of the equip-
ment for each tip geometry:
- primary tip vibration excursion;
- tip vibration frequency;
- half-excursion force.
The manufacturer shall specify the operating conditions (see 5.1) relevant to the declar-
ation of the essential output characteristics specified above.
1205 ©IEC:1993 - 17 -
Annex A
(informative)
General information about ultrasonic dental descalers (scalers)
A.1 Background
There are well over 130 000 ultrasonic dental descalers in use whose principal application
is in removing plaque and calculus from teeth [1]*. The unit consists of a generator, hand-
piece and various types of applicators which can be secured in the handpiece [2]. The
cleaning action is thought to be produced by: scraping or shearing action with direct con-
tact between the probe and the plaque and calculus; ultrasonic streaming and cavitation
produced in the field; the abrasive action of dislodged particles of calculus [3,4]. The wide
acceptance of ultrasonic units is based upon the clinical need to prevent as well as to treat
periodontal disease, which is both widespread and prevalent. Periodontal disease is the
major cause of loss of teeth in persons older than 35 years of age [5]. This is an inflamma-
tory process which is indirectly caused by various disease organisms. Ultrasonic units, in
skilled professional dental hands, provide a means of effective treatment for patients with
minimal to advanced disease states [6].
Despite its wide acceptance and usage in treatment of periodontal disease, the mode of
action has not been well characterized, nor have the acoustic parameters been well
documented. The ultrasonic frequency used
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.