BS EN 61205-1994 Specification for ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics《超声学规范 洗牙装置 输出特性测试和发布》.pdf

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1、BRITISH STANDARD BS EN 61205:1994 IEC 1205:1993 Specification for Ultrasonics Dentaldescaler systems Measurement and declaration of the output characteristics The European Standard EN 61205:1994 has the status of a British Standard UDC 615.47:616.314BSEN61205:1994 This British Standard, having been

2、prepared under the directionof the Electronic Equipment Standards Policy Committee, was published underthe authority of the Standards Board and comes intoeffect on 15 April 1994 BSI 11-1999 The following BSI references relate to the work on this standard: Committee reference EEL/35 Draft for comment

3、 90/26736 DC ISBN 0 580 23300 6 Cooperating organizations The European Committee for Electrotechnical Standardization (CENELEC), under whose supervision this European Standard was prepared, comprises the national committees of the following countries: Austria Italy Belgium Luxembourg Denmark Netherl

4、ands Finland Norway France Portugal Germany Spain Greece Sweden Iceland Switzerland Ireland United Kingdom Amendments issued since publication Amd. No. Date CommentsBSEN61205:1994 BSI 11-1999 i Contents Page Cooperating organizations Inside front cover National foreword ii Foreword 2 Text of EN 6120

5、5 3 National annex NA (informative) Committees responsible Inside back coverBSEN61205:1994 ii BSI 11-1999 National foreword This British Standard has been prepared under the direction of the Electronic Equipment Standards Policy Committee and is the English language version of EN61205:1994 Ultrasoni

6、cs Dental descaler systems Measurement and declaration of the output characteristics, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC1205:1993 published by the International Electrotechnical Commission (IEC). A British Standard does not pu

7、rport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front

8、 cover, pages i and ii, theEN title page, pages 2 to 12, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EURO

9、PISCHE NORM EN 61205 January 1994 UDC 615.47:616.314 Descriptors: Ultrasound, dental descaler, output characteristics, measurement English version Ultrasonics Dental descaler systems Measurementanddeclaration of the output characteristics (IEC 1205:1993) Ultrasons Systmes de dtartreurs dentaires Mes

10、ure et dclaration des caractristiques de sortie (CEI 1205:1993) Ultraschall Zahnreinigersysteme Messung und Deklaration der Ausganskennwerte (IEC1205:1993) This European Standard was approved by CENELEC on1993-12-08. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which

11、 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 Central Secretariat or to any CENELEC member. This European S

12、tandard 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 Secretariat has the same status as the official versions. CENELEC members are the na

13、tional electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normal

14、isation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1994 Copyright reserved to CENELEC members Ref. No. EN 61205:1994 EEN61205:1994 BSI 11-1999 2 Foreword The text of document 87(CO)26, as prepared by IECTechnical Committ

15、ee 87: Ultrasonics, was submitted to the IEC-CENELEC parallel vote in March1993. The reference document was approved by CENELEC as EN61205 on8December1993. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given

16、only for information. In this standard, Annex A and Annex B are informative and Annex ZA is normative. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative reference 3 3 Definitions of output characteristics 3 4 List of symbols 3 5 General measuring conditions 3 5.1 Operating conditions 3 5

17、.2 Load conditions 3 5.3 Cleaning of the apparatus 3 5.4 Irrigant temperature 3 6 Measurement procedures 4 6.1 Primary tip vibration excursion 4 6.2 Tip vibration frequency 4 6.3 Half-excursion force 4 7 Requirements for the declaration of essential output characteristics 4 Annex A (informative) Gen

18、eral information about ultrasonic dental descalers (scalers) 5 Annex B (informative) Guidance on the measurement methods 7 Annex ZA (normative) Other international publications quoted in this standard with thereferences of the relevant European publications 11 Figure 1 General arrangement for micros

19、copeslide method 8 Figure 2 Slide jig 9 Figure 3 Alternative general arrangement formicroscope slide method 10 latest date of publication ofan identical national standard (dop) 1994-12-01 latest date of withdrawal ofconflicting national standards (dow) 1994-12-01EN61205:1994 BSI 11-1999 3 Introducti

20、on 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 Stand

21、ard 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. 1 Scope This International Standard specifies: essential non-therma

22、l 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 wh

23、ich, 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 InternationalStandard are encouraged to investigate the p

24、ossibility of applying the most recent edition of the normative document listed below. Members of IEC and ISO maintain registers of currently valid InternationalStandards. IEC 782:1984, Measurements of ultrasonic magnetostrictive transducers. 3 Definitions of output characteristics For the purposes

25、of this International Standard, the following definitions apply: 3.1 half-excursion force force with which the tip must contact a glass slide so as to reduce the primary tip vibration excursion to50% of the value it has when the contact force is0,15N 0,02N 3.2 primary tip vibration excursion peak-to

26、-peak displacement of the applicator in the direction of maximum amplitude, at a point on the applicator not more than1mm from its tip 3.3 tip vibration frequency fundamental frequency at which the tip of the applicator oscillates 4 List of symbols 5 General measuring conditions 5.1 Operating condit

27、ions 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 ul

28、trasonic 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 force shall be0,15N 0,

29、02N. For the purposes of the half-excursion force measurement (see6.3), 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 k

30、nown 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 Irrigant temperature The irrigant shall emerge at a temperature between30 C and40

31、C or at the temperature specified by the manufacturer (seeclause7). s Primary tip vibration excursion. W o Width of score marks on a glass slide with power off. W p Width of score marks on a glass slide with power on.EN61205:1994 4 BSI 11-1999 6 Measurement procedures 6.1 Primary tip vibration excur

32、sion One of the following methods shall be used for measuring the primary tip vibration excursion. The accuracy of the vibration excursion measurement shall be better than 10% at1004m (see Annex B for more details of the measurement methods). Reports of measurements shall state clearly the load cond

33、itions and that the method satisfies the requirements of this InternationalStandard. NOTEThe maximum primary tip vibration excursion is in the region of1004m. At a constant drive frequency, the operator may have control of this excursion. 6.1.1 Optical microscope method A microscope shall be focused

34、 on a point on the applicator not more than1,0mm 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,

35、 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

36、 tip vibration excursion. 6.1.2 Glass slide method With the tip of the applicator in contact with the glass slide as specified in5.2, 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 ensu

37、re that the trace is perpendicular to the direction of maximum tip vibration. The primary tip vibration excursion, s, is given by: s = (W p W o ) 6.2 Tip vibration frequency One of the following methods shall be used to determine the tip vibration frequency. The accuracy of frequency measurement sha

38、ll 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 tha

39、t the tip vibration displacement is maximal. NOTEFor ultrasonic descaling equipment, the tip vibration frequency is in the range18000Hz to60000Hz. 6.2.1 Vibrometer method A non-contacting vibrometer should be used (seeAnnex B). The frequency of oscillation of the tip shall be measured from the outpu

40、t 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. 6.3 Half-excursion force During t

41、he procedure used to determine the primary tip vibration excursion (see6.1.1 or6.1.2), 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 is0,15N 0,02N (seeAnnex B). The force s

42、hall then be determined. NOTEAs 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 (0,15N 0,02N) is an indicator of the energy available for work. 7 Requirements f

43、or the declaration of essential output characteristics The manufacturer shall declare the following essential output characteristics of the equipment for each tip geometry: primary tip vibration excursion; tip vibration frequency; half-excursion force. The manufacturer shall specify the operating co

44、nditions (see5.1) relevant to the declaration of the essential output characteristics specified above. where W p is the width of the score marks with the power on W o is the width of the score marks with the power offEN61205:1994 BSI 11-1999 5 Annex A (informative) General information about ultrason

45、ic dental descalers (scalers) A.1 Background There are well over130000 ultrasonic dental descalers in use whose principal application is in removing plaque and calculus from teeth 1 1) . The unit consists of a generator, handpiece and various types of applicators which can be secured in the handpiec

46、e 2. The cleaning action is thought to be produced by:scraping or shearing action with direct contact 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 ultrasoni

47、c 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 than35years of age 5. This is an inflammatory process which is indirectly caused by various dis

48、ease 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 ha

49、ve the acoustic parameters been well documented. The ultrasonic frequency used is in the range18000Hz to60000Hz. The ultrasonic vibrating system is either a magnetostrictive stack or a piezoelectric element and the operative tool is usually driven at resonance. In some systems, the operator can adjust the frequency for the vibrating system to achieve resonance by judging when nebulizing effect on the irrigant is maximal. In others, the frequency is automatically controlled by the equipment. Several shap