1、BRITISH STANDARD BS EN 61206:1995 IEC 1206:1993 Ultrasonics Continuous-wave Doppler systems Testprocedures The European Standard EN61206:1995 has the status of a BritishStandardBSEN61206:1995 This BritishStandard, having been prepared under the directionof the Electrotechnical Sector Board, was publ
2、ished underthe authority of the Standards Board and comes intoeffect on 15October1995 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference EPL/87 Special announcement BSI News May1995 ISBN 0 580 24576 4 Committees responsible for this BritishStandard The
3、preparation of this BritishStandard was entrusted to Technical Committee EPL/87, Ultrasonics, upon which the following bodies were represented: British Dental Association British Institute of Radiology British Medical Ultrasound Society British Society for Rheumatology Department of Health Departmen
4、t of Trade and Industry (National Physical Laboratory) Institute of Laryngology and Otology Institute of Physical Sciences in Medicine Institution of Electrical Engineers Amendments issued since publication Amd. No. Date CommentsBSEN61206:1995 BSI 01-2000 i Contents Page Committees responsible Insid
5、e front cover National foreword ii Foreword 2 Text of EN61206 3 List of references Inside back coverBSEN61206:1995 ii BSI 01-2000 National foreword This BritishStandard has been prepared by Technical Committee EPL/87 and is the English language version of EN61206:1995 Ultrasonics, Continuous-wave Do
6、ppler systems Test procedures, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with Technical Report IEC1206:1993, published by the International Electrotechnical Commission (IEC). The UnitedKingdom voted against this document being harmonized as a
7、n EN, as the IEC Technical Report Type2 was not intended to be regarded as an International Standard, but only as a prospective standard for provisional application, for guidance on how standards in this field should be used to meet an identified need. The IEC Technical Report is due for further rev
8、iew three years after publication, with the options of either extension for a further three years or conversion to an International Standard, or withdrawal. The EN will correspondingly be automatically reviewed after a period of five years or earlier depending on the outcome of the IEC review. A Bri
9、tish 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 confer immunity from legal obligations. Cross-references Publication referred to Corre
10、sponding BritishStandard EN61102:1993 (IEC1102:1991) BS EN61102:1994 Specification for measurement and characterisation of ultrasonic fields using hydrophones in the frequency range0.5MHz to15MHz Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theEN title
11、 page, pages2 to22, 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 EUROPISCHE NORM EN 61206 February 1995 IC
12、S 17.140.50;11.040.50 Descriptors: Ultrasound, Doppler, continuous wave, test procedure English version Ultrasonics Continuous-wave Doppler systems Test procedures (IEC1206:1993) Ultrasons Ensembles effet Doppler ondes entretenues Mthodes dessai (CEI1206:1993) Ultraschall Dauerschall Doppler System
13、Prfverfahren (IEC1206:1993) This European Standard was approved by CENELEC on1994-12-06. 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
14、 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
15、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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxe
16、mbourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brusse
17、ls 1995 Copyright reserved to CENELEC members Ref. No. EN61206:1995 EEN61206:1995 BSI 01-2000 2 Foreword The text of the International Standard IEC1206:1995, prepared by IEC TC87, Ultrasonics, was submitted to the formal vote and was approved by CENELEC as EN61206 on1994-12-06 without any modificati
18、on. 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 A, Annex B and Annex C are informative. Annex ZA has been added by CENELEC. Cont
19、ents Page Foreword 2 Introduction 3 Section 1. General 1.1 Scope 3 1.2 Normative reference 3 1.3 Definitions 3 1.4 Symbols 4 Section 2. Overall tests of complete systems 2.1 General considerations 4 2.1.1 Types of Doppler ultrasound systems 4 2.1.2 Worst case conditions 4 2.2 Initial conditions 5 2.
20、2.1 Power supply 5 2.2.2 Test frequency, general conditions 5 2.2.3 Working distance 6 2.2.4 Zero-signal noise level 6 2.3 Doppler frequency response 6 2.3.1 Frequency response range 6 2.3.2 Doppler frequency accuracy 7 2.3.3 Large-signal performance 7 2.4 Spatial response 8 2.4.1 Axial response 8 P
21、age 2.4.2 Lateral response 8 2.5 Operating frequency 9 2.5.1 Acoustical measurement 9 2.5.2 Electrical measurement 9 2.6 Flow direction separation 9 2.6.1 Channel separation 9 2.6.2 Simultaneous flow 9 2.7 Response to Doppler spectrum 10 2.7.1 Volume-flow circuits 10 2.7.2 Maximum-frequency follower
22、s 10 Section 3. Special doppler test objects 3.1 Doppler test objects 10 3.1.1 String Doppler test object 10 3.1.2 Band Doppler test object 11 3.1.3 Disk Doppler test object 12 3.1.4 Piston Doppler test object 12 3.1.5 Small ball test object 12 3.1.6 Flow Doppler test object 12 3.1.7 Water tank (or
23、gel block) 13 Annex A (informative) Description of continuous-wave Doppler ultrasound systems 17 Annex B (informative) Rationale 20 Annex C (informative) Bibliography 21 Annex ZA (normative) Other international publications quoted in this standard with the references of the relevant European publica
24、tions 21 Figure 1 Schematic diagram of a string Doppler test object 14 Figure 2 Schematic diagram of band, disc and piston Doppler test objects 15 Figure 3 Schematic diagram of a flow Doppler test objects with pump return 16 Figure A.1 Example of single-channel directional Doppler ultrasound system
25、18 Figure A.2 Example of directional Doppler receiver and signal processing 19 Table 1 Worst case quantities, and corresponding subclause numbers 5 latest date by which the ENhas to be implemented at national level by publication of an identical national standard or by endorsement (dop)1995-12-15 la
26、test date by which the national standards conflicting with the EN haveto be withdrawn (dow)1995-12-15EN61206:1995 BSI 01-2000 3 Introduction Continuous-wave ultrasonic Doppler flowmeters, velocimeters, or foetal heart detectors are widely used in clinical practice. This type of medical ultrasonic eq
27、uipment measures the Doppler-shift frequency which is the change in frequency of an ultrasound scattered wave caused by relative motion between a scatterer and the ultrasonic transducer. This frequency is proportional to the observed velocity, which is the component of the velocity of a scatterer th
28、at is directed towards or away from the transducer. This technical report describes a range of test methods that may be applied to determine various performance parameters for continuous-wave Doppler ultrasound systems. They may also be applied to pulsed Doppler systems although additional tests wou
29、ld also be required. The test methods are based on the use of a number of specialised devices such as string, band, disk, piston and flow Doppler test objects. These test methods may be considered as falling into one of the following three categories. The first is routine quality control tests that
30、can be carried out by a clinician or a technologist to ensure that the system is working adequately or has adequate sensitivity. The second is more elaborate test methods, conducted less frequently, such as when the system is suspected of not working properly. The third represents tests that would b
31、e done by a manufacturer on complete systems, as the basis of type specification of performance. Section 1. General 1.1 Scope This technical report describes: test methods for measuring the performance of continuous-wave ultrasonic Doppler flowmeters, velocimeters, or foetal heart detectors; special
32、 Doppler test objects for determining various performance properties of Doppler ultrasound systems. This technical report applies to: tests made on an overall Doppler ultrasound system; a system which is not disassembled or disconnected; tests made on continuous-wave Doppler ultrasound systems. The
33、same tests can be applied to Doppler ultrasound systems which measure position as well as velocity, such as pulsed and frequency-modulated Doppler systems, although additional tests may then be required. Electrical safety and acoustic output are not covered in this technical report 1.2 Normative ref
34、erence The following standard contains provisions which, through reference in this text, constitute provisions of this technical report. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this technical report are en
35、couraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC 1102:1991, Measurement and characterisation of ultrasonic fields using hydrophones in the frequency
36、 range0,5MHz to15MHz. 1.3 Definitions For the purposes of this technical report, the following definitions apply: 1.3.1 direction sensing; directional descriptor of a type of Doppler ultrasound system which indicates whether scatterers are approaching or receding from the ultrasonic transducer 1.3.2
37、 direction resolving; direction separating descriptor of a type of Doppler ultrasound system in which the Doppler output appears at different output terminals, output channels or output devices depending upon the direction of scatterer motion relative to the transducer 1.3.3 doppler frequency; doppl
38、er-shift frequency change in frequency of an ultrasound scattered wave caused by relative motion between the scatterer and the transducer. It is the difference frequency between the transmitted and the received wave 1.3.4 doppler output; direct output; doppler frequency output voltage at the Doppler
39、 frequency or at Doppler frequencies which activates the output device 1.3.5 doppler output connector electrical connector or that part of a Doppler ultrasound system at which the Doppler output is available for connection to external output devicesEN61206:1995 4 BSI 01-2000 NOTENot all Doppler ultr
40、asound systems have a physical connector at which the Doppler output is available. 1.3.6 doppler spectrum set of Doppler frequencies produced by a Doppler ultrasound system 1.3.7 doppler test object artificial structures used in testing Doppler ultrasound systems. They produce ultrasonic reflections
41、 that are similar to those produced by the structures on which the Doppler ultrasound systems are to be used NOTEDoppler test objects are often referred to as phantoms. 1.3.8 doppler ultrasound system; system equipment designed to transmit and receive ultrasound and to generate a Doppler output from
42、 the difference in frequency between the transmitted and received waves 1.3.9 non-directional descriptor of a type of Doppler ultrasound system which is not direction sensing 1.3.10 observed velocity component of the velocity of a scatterer that is directed towards or away from the transducers 1.3.1
43、1 operating frequency the ultrasonic or electrical frequency of operation of an ultrasonic transducer forming part of a Doppler ultrasound system 1.3.12 output channel part of a Doppler ultrasound system which functionally represents a particular aspect of theDoppler output NOTEA Doppler ultrasound
44、system may have two output channels, each representing a flow in a particular direction. 1.3.13 output device any device included in a Doppler ultrasound system or capable of being connected to it that makes the Doppler output accessible to the human senses 1.4 Symbols Section 2. Overall tests of co
45、mplete systems 2.1 General considerations 2.1.1 Types of Doppler ultrasound systems A major factor that affects performance testing of a Doppler ultrasound system (system) is whether it can be described as directional, non-directional, or as direction resolving. Directional or direction sensing refe
46、rs to a type of system which indicates whether scatterers are approaching or receding from the ultrasonic transducer. Non-directional systems do not indicate direction of scatterer motion. Direction resolving, or direction separating systems provide for Doppler output to appear at different output c
47、hannels depending upon the direction of scatterer motion. Annex A gives descriptions and examples of these different types of systems. 2.1.2 Worst case conditions A test method may be applied to determine a particular performance parameter of a system. Often a number of quantities can have a bearing
48、 on overall performance, each one of which requires the application of a distinct test method. Some of these quantities need to be maximised and others need to be minimised in order to obtain the best overall performance. Considering overall performance, Table 1 gives the worst case conditions for k
49、ey quantities appropriate to peripheral vascular systems and the corresponding clause number which describes a suitable test method. Table 1 may need modification to be appropriate for other uses. As an example, if the noise as measured in2.2.4 is maximised this will lead to worst case overall performance; conversely, minimising noise will lead to maximised performance. The situation for spatial response (see clause2.4), is discussed in the rationale (see Annex B). c is the average speed of sound in a medium. I is the average speed of the fl
