1、NORME CE1 I NTE RN ATION ALE INTERNATIONAL STANDARD I EC 1266 Premire dition First edition 1994-1 2 Ultrasons - Dtecteurs des battements de coeur foetal effet Doppler avec sonde main - Prescriptions de performance et mthodes de mesure et de signalement Ultrasonics - Hand-held probe Doppler foetal he
2、artbeat detectors - Performance requirements and methods of measurement and reporting Numro de rfrence Reference number CEIA EC 1266: 1994 Numros des publications Depuis le ler janvier 1997, les publications de la CE1 sont numrotes partir de 60000. Publications consolides Les versions consolides de
3、certaines publications de la CE1 incorporant les amendements sont disponibles. Par exemple, les numros ddition 1.0, 1.1 et 1.2 indiquent respectivement la publication de base, la publication de base incorporant lamendement 1, et la publication de base incorporant les amendements 1 et 2. Validit de l
4、a prsente publication Le contenu technique des publications de la CE1 est constamment revu par la CE1 afin quil reflte ltat actuel de la technique. Des renseignements relatifs la date de reconfirmation de la publication sont disponibles dans le Catalogue de la CEI. Les renseignements relatifs des qu
5、estions ltude et des travaux en cours entrepris par le comit technique qui a tabli cette publication, ainsi que la liste des publications tablies, se trouvent dans les documents ci- dessous: Site web de la CEI* Catalogue des publications de la CE1 Publi annuellement et mis jour rgulirement (Catalogu
6、e en ligne) Disponible la fois au site web, de la CEI* et comme priodique imprim Bulletin de la CE1 Terminologie, symboles graphiques et littraux En ce qui concerne la terminologie gnrale, le lecteur se reportera la CE1 60050: Vocabulaire Electro- technique International (VE i). Pour les symboles gr
7、aphiques, les symboles littraux et les signes dusage gnral approuvs par la CEI, le lecteur consultera la CE1 60027: Symboles littraux d utiliser en lectrotechnique, la CE1 6041 7: Symboles graphiques utilisables sur le matriel. Index, relev et compilation des feuilles individuelles, et la CE1 6061 7
8、: Symboles graphiques pour schmas. Voir adresse site web, sur la page de titre. Numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. Consolidated publications Consolidated versions of some IEC publications including amendments are available. For ex
9、ample, edition numbers 1 .O, 1 .l and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Validity of this publication The technical content of IEC publications is kept under constant review by th
10、e IEC, thus ensuring that the content reflects current technology. Information relating to the date of the reconfirmation of the publication is available in the IEC catalogue. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepare
11、d this publication, as well as the list of publications issued, is to be found at the following IEC sources: IEC web site* Catalogue of IEC publications Published yearly with regular updates (On-line catalogue)* Available both at the IEC web site* and as a printed periodical IEC Bulletin Terminology
12、, graphical and letter symbols For general terminology, readers are referred to I EC 60050: International Electrotechnical Vocabulary (IEV). For graphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred to publications IEC 60027: Letter symbols to be u
13、sed in electrical technology, IEC 60417: Graphical symbols for use on equipment. Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols for diagrams. * See web site address on title page. NORME INTERNATIONALE INTERNATIONAL STANDARD CE1 IEC 1266 Premire dition First editi
14、on 1994-1 2 Ultrasons - Dtecteurs des battements de coeur foetal effet Doppler avec sonde main - Prescriptions de performance et mthodes de mesure et de signalement Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting 0
15、CE1 1994 Droits de reproduction rservs - Copyright - all rights reserved Aucune partie de tte publication ne peut tre reproduite ni utilis8e sous quelque forme que soit e( par aucun pro- cd. lectronique ou mcanique. y compris la photocopie et les microfilms, sans Iamrd any IEC National Committee int
16、erested 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 accorda
17、nce 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 which all the National Committees having a special interest therein are represented, express, as nearly as possible, an i
18、nternational consensus of opinion on the subjects dealt with. They have the form of recommendations for international use published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. In order to promote international unification, IEC
19、 National Committees undertake to apply IEC International 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. internation
20、al Standard iEC 1266 has been prepared by IEC technical committee 87: Ultrasonics. The text of this standard is based on the following documents: Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. Ail annexes are for in
21、formation only In this standard the following print types are used: - - Requirements proper: in roman type. Test specifications: in italic type. Words in bold in the text are defined in clause 3. - Notes: in smaller roman type. - -6- 1266 O CEI:l994 INTRODUCTION Les dtecteurs des battements de coeur
22、 foetal ultrasonores a effet Doppler avec sonde main sont largement utiliss pour surveiller le coeur foetal pendant la grossesse. Ils fonctionnent normalement des frquences denviron 2 MHz et comportent un trans- ducteur ultrasons coupl dans le domaine acoustique labdomen maternel et de lappareillage
23、 lectronique. Un faisceau dultrasons est dirig par loprateur de manire atteindre le coeur foetal et une faible partie des ultrasons incidents est rflchie par la surface mobile du coeur. Ces ultrasons sont soumis une drive en frquence par effet Doppler. On les dtecte alors grce un transducteur rcepte
24、ur. Le traitement des signaux spare les signaux basse frquence associs aux battements du coeur foetal et les oscillations ultrasoniques haute frquence, et les amplifie pour une dtection audio. La prsente Norme internationale, la CE1 1266, spcifie des mthodes dvaluation des performances des dtecteurs
25、 des battements de coeur foetal ultrasonores et, en particulier, elle spcifie une mthode de dtermination de la sensibilit du systme pour la dtection dune cible mobile. Les systmes de surveillance foetale Doppler utilisent une sonde plate attache au patient et fonctionnent suivant le mme principe que
26、 les dtecteurs des battements de coeur foetal avec sonde main mais ne sont pas couverts par cette norme. La raison en est que les systmes de surveillance ncessitent un angle large dexamen ralis souvent par lutilisation dun transducteur plusieurs elements. Celle-ci rend la mise en oeuvre des appareil
27、s de surveillance foetale a Doppler beaucoup plus complexe que celle des dtecteurs des battements de coeur foetal avec sonde a main qui utilise un faisceau troit. Les mthodes de vrification des performances seraient aussi plus complexes. 1266 0 IEC:1994 -7- INTRODUCTION I md-held ultrasonic Doppler
28、foetal heartbeat detectors are widely u L 3d for m nitoring foetal heartbeat during pregnancy. They normally operate at frequencies of circa 2 MHz, and consist of an ultrasonic transducer acoustically coupled to the maternal abdomen and associated electronics. A beam of ultrasound is directed by the
29、 operator to impinge on the foetal heart and a small fraction of the incident ultrasound is reflected from the moving surfaces of the heart. This ultrasound is subject to a frequency shift as a result of the Doppler effect. It is then detected by a receiving transducer. Signal processing separates t
30、he low-frequency signals associated with the foetal heartbeat from the high-frequency ultrasonic oscillations and amplifies them for audio detection. This International Standard, IEC 1266, specifies methods of evaluating the performance of ultrasonic foetal heartbeat detectors and, in particular, sp
31、ecifies a method of determining the sensitivity of the system to the detection of a moving target. Foetal Doppler monitoring devices use a flat probe strapped to the patient and work on a principle similar to that of hand-held foetal heartbeat detectors but are not covered by this standard. The reas
32、on is that monitoring devices require a wide angle of view which is often realised by using a multi-element transducer. This makes the method of operation of foetal Doppler monitors much more complex than that of hand-held foetal heartbeat detec- tors which use a narrow beam. Methods of assessment of performance would also be more complex.