BS EN 61847-1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics《超声波 外科装置 基本输出特性的测量和说明》.pdf

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1、BRITISH STANDARD BS EN 61847:1998 IEC61847: 1998 Ultrasonics Surgical systems Measurement and declaration of the basic output characteristics The European Standard EN61847:1998 has the status of a British Standard ICS11.040.50BSEN 61847:1998 This British Standard, having been prepared under the dire

2、ctionof the Electrotechnical Sector Board, was published underthe authority of the Standards Board and comes intoeffect on 15 May1998 BSI04-1999 ISBN 0 580 29318 1 National foreword This British Standard is the English language version of EN61847:1998. It is identical with IEC61847:1998. The UK part

3、icipation in its preparation was entrusted to Technical Committee EPL/87, Ultrasonics, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UKinter

4、ests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. From1 January1997, all IEC publications have the number60000 added to the old number. For instance,

5、 IEC27-1 has been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists

6、 normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”

7、, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport 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 conf

8、er immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages 2 to 26 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in

9、 the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN 61847:1998 BSI 04-1999 i Contents Page National foreword Inside front cover Foreword 2 Text of EN61847 5ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN61847 February1998 ICS11.

10、040.01; 17.140.50 English version UltrasonicsSurgical systems Measurement and declaration of the basic output characteristics (IEC61847:1998) UltrasonsSystmes de chirurgie Mesure et dclaration des caractristiques de sortie (CEI61847:1998) UltraschallChirurgische Systeme Messung und Deklaration der A

11、usgangsgren (IEC61847:1998) This European Standard was approved by CENELEC on1998-01-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date

12、 lists and bibliographical references concerning such national standards may be obtained on 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 t

13、he 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 national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irel

14、and, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart

15、35, B-1050 Brussels 1998 CENELECAll rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN61847:1998 EEN61847:1998 BSI 04-1999 2 Foreword The text of document87/114/FDIS, future edition1 of IEC61847, prepared by IEC TC87, Ultrasonics, was submitted to

16、 the IEC-CENELEC parallel vote and was approved by CENELEC as EN61847 on1998-01-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex ZA is normative and Annex

17、A, Annex B and Annex C are informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC61847:1998 was approved by CENELEC as a European Standard without any modification. latest date by which the EN has to be implemented at national level by publicat

18、ion of an identical national standard or by endorsement (dop) 1998-10-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 1998-10-01EN61847:1998 BSI 04-1999 3 Contents Page Foreword 2 Introduction 5 1 Scope 5 2 Normative references 5 3 Definitions 5 4 Li

19、st of symbols 7 5 General measurement requirements 7 5.1 Operating conditions 7 5.2 Load conditions 8 5.3 Preparation for measurements 8 6 Measurement procedures 8 6.1 Primary tip vibration excursion 8 6.2 Secondary tip vibration excursion 9 6.3 Drive frequency 9 6.4 Tip vibration frequency 9 6.5 De

20、rived output acoustic power and output acoustic power 9 6.6 Directivity pattern 10 6.7 Primary tip vibration excursion modulation 10 6.8 Duty cycle 11 6.9 Quiescent electrical power 11 6.10 Maximum electrical power 11 6.11 Primary acoustic output area 11 6.12 Secondary acoustic output area 12 6.13 P

21、ower reserve index 12 7 Declaration of output characteristics 12 Annex A (informative) Measurement methods and conditions 18 Annex B (informative) Theory of operation of ultrasonic surgical devices 22 Annex C (informative) Bibliography 24 Annex ZA (normative) Normative reference to internationalpubl

22、ications with their corresponding European publications 26 Figure 1 Measuring the primary and secondary tip vibration excursion 13 Figure 2 Example of a primary acoustic output area 14 Figure 3 Measuring the pressure field 15 Page Figure 4 Illustration of the method of determining duty cycle from an

23、 oscilloscope trace.The dotted line is at a level equal to theminimum peak-to-peak level plus10%ofthedifference between the maximumandthe minimum peak-to-peak levels 15 Figure 5 Measuring the maximum electricalpower (P max) at a given primary tip vibration excursion (s p ) 16 Figure 6 Example of a s

24、econdary acoustic output area 17 Figure A.1 A typical relationship between tip vibration amplitude and acoustic pressure 21 Figure A.2 Schematic diagram of the theoreticalmodel geometry for the tip immersedbelow the surface of the water 214 blankEN61847:1998 BSI 04-1999 5 Introduction Ultrasonic sur

25、gical systems, operating in the20kHzto60kHz range, are used widely in ophthalmology and neurosurgery to fragment or disintegrate and aspirate unwanted tissue. Their commercial use in ophthalmology started in1970. Their application in neurosurgery followed about10years later. Ultrasonic surgical syst

26、ems are also widely used in oncology surgery. This International Standard defines the parameters which characterize the output and performance of open and closed site ultrasonic surgical systems, and indicates which parameters should be declared. In addition, measurement procedures are described so

27、that technically qualified people will be able to report on the parameters in a uniform and understandable fashion. An open surgical site is one in which the incision is large relative to the size of the applicator tip being inserted thus precluding any increase in pressure of the organ due to an im

28、balance of irrigant flow and suction flow. An example of a closed surgical site is an eye where the incision is closely controlled. This International Standard does not provide any guidance on what is the resultant safety or efficacy of devices described by these parameters since very little scienti

29、fically controlled data are available by which such judgements can be made. 1 Scope This International Standard specifies: the essential non-thermal output characteristics of ultrasonic surgical units; NOTE 1One of the parameters of interest is output acoustic power. This standard addresses only the

30、 low-frequency (under100kHz) component of the total delivered energy. The high-frequency component, which probably relates to cavitation developed at the tip, is not addressed (seeA.4). methods of measurement of these output characteristics; those characteristics which should be declared by the manu

31、facturers of such equipment. NOTE 2In the interest of clarity, this standard does not address all of the complex surfaces and shapes possible for applicator tips. A straight tubular shape is used in the description of the parameters and measurements to be made. It is left to the user of this standar

32、d to adapt the basic methodology described to more complex designs if required. This International Standard is applicable to equipment which meets the requirements of a, b andcbelow: a) ultrasonic surgical systems operating in the frequency range20kHz to60kHz; and b) ultrasonic surgical systems, who

33、se use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the sur

34、gical site. NOTE 3Examples of these types of systems are surgical aspirators, intracorporeal lithotripters, end-cutting devicesetc. This International Standard is not applicable to: lithotripsy equipment which uses extracorporeally induced pressure pulses, focussed through liquid conducting media an

35、d the soft tissues of the body; surgical devices used as part of the therapeutic process (hyperthermia systems); surgical devices whose acoustic application areas are not at the end of a longitudinally vibrating applicator tip and therefore would not fit the monopole model used in this standard. Thi

36、s International Standard does not deal with the effectiveness or safety of ultrasonic surgical systems. NOTE 4Throughout this standard, the term accuracy means the overall uncertainty expressed at the95% confidence level. 2 Normative references The following normative documents contain provisions wh

37、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 International Standard are encouraged to investigate the

38、possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC60500:1974, IEC standard hydrophone. IEC61205:1993, UltrasonicsDental descaler systemsMeasurement and declaration of t

39、he output characteristics. 3 Definitions For the purpose of this International Standard, the following definitions apply. 3.1 applicator tip; applied part that part of the surgical tool which comes into direct contact with body tissuesEN61847:1998 6 BSI 04-1999 3.2 directivity pattern normalized var

40、iation in acoustic pressure as a function of angle at constant range from the applicator tip NOTEThis parameter is important when operating adjacent to body structures which are sensitive to pressure and motion such as the endothelial cells on the inside of the cornea or acoustic nerves. Symbol: P f

41、d Unit: dimensionless plot 3.3 drive frequency mean frequency of the driving voltage or current NOTEThis parameter, coupled with tip vibration excursion, allows the user to compare the velocities of applicator tips. Symbol: f d Unit: kilohertz, kHz 3.4 duty cycle for those systems which modulate the

42、 electrical drive power, the ratio of the voltage or current pulse duration (on time) to the duration of one complete modulation cycle while the equipment is active Symbol: D cy Unit: dimensionless 3.5 maximum electrical power the peak input electrical power to the ultrasonic handpiece when the load

43、 on the applicator tip is gradually increased from its quiescent condition NOTEThe peak electrical power occurs at the point at which a reduction in the primary tip vibration excursion from its value corresponding to the quiescent electrical power occurs (see6.9 and6.10). Symbol: P max Unit: watts,

44、W 3.6 output acoustic power the acoustic power delivered by the applicator tip into water, and measured using a calorimetric method (see6.5) NOTEMeasurement of acoustic power delivered by applicator tips having different output areas and/or excursion amplitudes will facilitate application of the ALA

45、RA principle, the use of exposure levels that are as low as reasonably achievable. Symbol: P a Unit: milliwatts, mW 3.7 derived output acoustic power the acoustic power delivered by the applicator tip into water, and derived from measurements made using a hydrophone (see6.5) NOTEMeasurement of acous

46、tic power delivered by applicator tips having different output areas and/or excursion amplitudes will facilitate application of the ALARA principle, the use of exposure levels that are as low as reasonably achievable. Symbol: P ad Unit: milliwatts, mW 3.8 power reserve index the ratio of maximum ele

47、ctrical power to quiescent electrical power NOTE 1The power reserve index gives the user a measure of how much “extra” power is available to maintain a constant tip excursion amplitude under various load conditions. Symbol: P i Unit: dimensionless NOTE 2The power reserve index will only allow direct

48、 comparison of different devices if those devices share the same operating modality. Piezoelectric and magnetostrictive devices cannot be validly compared using the power reserve index. 3.9 primary acoustic output area the area of the projection of the solid part of the applicator tip in the directi

49、on of primary tip vibration excursion NOTEPrimary acoustic output area is used in determining the energy radiated from the end of an applicator tip for different tips operating at the same vibration excursion and frequency. Symbol: A ap Unit: square millimetres, mm 2 3.10 primary tip vibration excursion peak-to-peak displacement of the applicator tip in the direction of maximum amplitude, at a point on the applicator tip not more than1mm from its free (distal) end (see3.2 of IEC61205) NOTEThe ability to fragment tissue can b