1、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM H 3404583 0100427 300 = EN 61205 January 1994 UDC 615.47 : 616.314 Descriptors: Ultrasound, dental descaler, output characteristics, measurement English version Ultrasonics - Dental descaler systems Measurement and declaration of the output character
2、istics (IEC 1205 : 1993) Ultrasons - Systmes de dtartreurs dentaires - Mesure et dclaration des caractristiques de sortie (CE1 1205 : 1993) Ultraschall - Zahnreinigersysteme Messung und Deklaration der Ausganskennwerte (IEC 1205 : 1993) This European Standard was approved by CENELEC on 1993-12-08. C
3、ENELEC members are bound to comply with the CENICENELEC 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 o
4、n application to the Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified to the Central Se
5、cretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENE
6、LEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels O 1994 Copyright reserved to CENELEC members Ref. No. EN 61205 : 1994 E = 3404583 0300
7、428 247 Page 2 EN 61205 : 1994 Foreword The text of document 87(C0)26, as prepared by IEC Technical Committee 87: Ultrasonics, was submitted to the IEC-CENELEC parallel vote in March 1993. The reference document was approved by CENELEC as EN 61205 on 8 December 1993. The following dates were fixed:
8、- latest date of publication of an identical national standard (dop) 1994-12-01 - latest date of withdrawal of conflicting national standards (dow) 1994-12-01 Annexes designated normative are part of the body of the standard, Annexes designated informative are given only for information. In this sta
9、ndard, annexes A and B are informative and annex ZA is normative. 3404583 0300429 383 Page 3 EN 61205 : 1994 CONTENTS Page INTRODUCTION 4 Clause Scope 5 Normative reference 5 Definitions of output characteristics 5 List of symbols 6 General measuring conditions . 6 5.1 Operating conditions 6 5.2 Loa
10、d conditions 6 5.3 Cleaning of the apparatus . 6 5.4 Irrigant temperature . 6 Measurement procedures . 6 6.1 Primary tip vibration excursion . 6 6.2 Tip vibration frequency 7 6.3 Half-excursion force 8 8 Requirements for the declaration of essential output characteristics . Annexes A General informa
11、tion about ultrasonic dental descalers (scalers) . 9 B Guidance on the measurement methods . 13 Figures . 15 Bibliography . 12 Annex ZA (normative) Other international publications quoted in this standard with the references of the relevant European publications 17 M 3404583 0100430 T5 Page 4 EN 612
12、05 : 1994 INTRO DU CTIO N 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 t
13、his 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. 3404583 OLO043L 831 Page 5 EN 61205 : 1994 U
14、LTRASONICS - 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 desca
15、lers; - 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 edition
16、s indicated were valid. All normative documents are subject to revision, and patties 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 IS0 maintain registers
17、of currently valid International Standards. I EC 782: 1984, Measurements of ultrasonic magnetostrictive transducers 3 Definitions of output characteristics For the purposes of this International Standard, the following definitions apply. 3.1 half-excursion force: Force with which the tip must contac
18、t 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 I0,02 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
19、 1 mm from its tip. 3.3 tip vibration frequency: Fundamental frequency at which the tip of the applicator oscillates. m 3404583 0300432 778 m Page 6 EN 61205 : 1994 4 List of symbols s Primary tip Vibration excursion. Wo Width of score marks on a glass slide with power off. Wp Width of score marks o
20、n a glass slide with power on. 5 General measurlng 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
21、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 lub
22、ricated with water (tap water is sufficient) and the standard contact force shall be 0,15 N f 0.02 N. For the purposes of the half-excursion 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, t
23、he 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
24、dried in air. 5.4 Irrigant temperature The irrigant shall emerge at a temperature between 30 OC and 40 OC or at the temperature specified by the manufacturer (see clause 7). 6 Measurement procedures 6.1 Primary tip vibration excursion One of the following methods shall be used for measuring the prim
25、ary tip vibration excursion. The accuracy of the vibration excursion measurement shall be better than 110% at 100 pm (see annex B for more details of the measurement methods). Reports of measurements shall state clearly the load conditions and that the method satisfies the requirements of this Inter
26、national Standard. NOTE - The maximum primary tip vibration excursion is in the region of 100 pm. 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 t
27、ip. 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 reti
28、cule 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 th
29、e 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 ma
30、ximum tip vibration. The primary tip vlbration excur- sion, s, is given by: s = (WP - wo, where Wp Wo is the width of the score marks with the power on 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 vibra
31、tion frequency. The accuracy of frequency measurement shall be better than il %. 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 me
32、asured 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 O00 Hz to 60 O00 Hz. 6.2.1 Vibrometer method A non-contacting vibrometer should be used (see annex B). The
33、 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
34、 voltage applied to the applicator. 3404583 0300434 540 W Page 8 EN 61205 : 1994 6.3 Half-excursion force During the procedure used to determine the primary tip vibration excursion (see 6.1 .i or 6.1.2), the force exerted by the tip on the microscope slide shall be increased until the primary tip vi
35、bration excursion has been reduced to half of the value it has when the force is 0,15 N i 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 th
36、e value it has under standard load conditions (O, 15 N f 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 geom
37、etry: - 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. 3404583 0100435 487 Page 9 EN 61205 : 1994 Annex A (i n
38、f or mat ive) General information about ultrasonic dental descalers (scalers) A.l Background There are well over 130 O00 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 o
39、f 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 partic
40、les 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 SI. This is an inflam
41、ma- 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,
42、the mode of action has not been well characterized, nor have the acoustic parameters been well documented. The ultrasonic frequency used is in the range 18 O00 Hz to 60 O00 Hz. The ultrasonic vibrating system is either a magnetostrictive stack or a piezoelectric element and the operative tool is usu
43、ally driven at resonance. In some systems, the operator can adjust the frequency for the vibrating system to achieve resonance by judging when nebu- lizing effect on the irrigant is maximal. In others, the frequency is automatically controlled by the equipment. Several shapes of descaling tools are
44、available but most tools contain a bend shortly after emerging from the handpiece. This converts the longitudinal vibration of the vibrating system to an elliptical movement of the tip of the tool l. These devices are not 100 % efficient, thus heat is generated, especially in the mag- netostrictive
45、kinds. To dissipate this heat, as well as the frictional heat of the tip acting on the tooth surface, a fluid irrigant generally flows through the handpiece then over the tip and to the point of contact with the surface of the tooth. This fluid is usually water although saline is sometimes used. The
46、 temperature of the irrigant is controlled by regulat- ing the flow. It is customary to adjust the flow so that the temperature is slightly below that of the oral cavity. The irrigant also produces other desirable effects including lubrication and cleaning and it promotes cavitation, an important fe
47、ature as far as descaling is concerned (71. See clause A.4 for references. Page 10 EN 61205 : 1994 3404583 0300436 333 Skill and training are required in the use of this device so as to avoid damage to the patient. In practice, the operator is instructed to use a light touch (0,15 N) 4. The vibratio
48、n of the tip aids in dislodging the plaque and calculus. Cavitation produced by the vibrating tip may be responsible for the effectiveness of the tool in cleaning surfaces not directly accessible to the tip 1,4. Considerable variation in the acoustic output of the device can occur depending, for exa
49、mple, on operator techniques, available generator power, power setting, tuning, coupling and tip configuration. Pressure of the tip against the surface of the tooth may change the resonant characteristics of the assembly (loading). Thus, for maximum cleaning efficiency, it is desirable that the tip amplitude be adjusted for resonance when in contact with a surface. A.2 Hazards of operatlon A.2.1 Thermal damage Investigations into the influence of ultrasonic energy have demonstrated active hyper- aemia and cell damage due to prolonged application or high-power ope
