SIST EN 61206:2002

Ultrasonics - Continuous-wave Doppler systems - Test procedures

Describes the test methods for measuring the performance of continuous-wave ultrasonic Doppler flowmeters, velocimeters, or foetal heart detectors and special Doppler test objects for determining various performance properties of Doppler ultrasound systems. Does not include electrical safety and acoustic output. This publication has the status of a type 2 technical report.

Ultraschall - Dauerschall Doppler System - Prüfverfahren

Ultrasons - Ensembles à effet Doppler à ondes entretenues - Méthodes d'essai

Décrit des méthodes d'essai pour mesurer les performances d'ensembles ultrasonores à effet Doppler à ondes entretenues pour la mesure des écoulements, des vitesses d'écoulement ou pour la détection des battements du coeur foetal et des montages spéciaux pour effet Doppler pour déterminer des propriétés diverses de fonctionnement d'ensembles ultrasonores à effet Doppler. La sécurité électrique et la sortie acoustique ne relèvent pas de ce rapport technique. Cette publication a le statut d'un rapport technique de type 2.

Ultrasonics - Continuous-wave Doppler systems - Test procedures (IEC 61206:1993)

General Information

• Status: Published
• Publication Date: 31-Aug-2002
• ICS: 11.040.50 - Radiographic equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: SS EIT - Technical Board for the electrotechnical, information technology and telecommunications fields
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2002
• Due Date: 01-Sep-2002
• Completion Date: 01-Sep-2002
• Ref Project: EN 61206:1995 - Ultrasonics - Continuous-wave Doppler systems - Test procedures

Overview

EN 61206:1995 (adopted as SIST EN 61206:2002) is a European technical report that defines test procedures for continuous-wave (CW) ultrasonic Doppler systems. It covers methods for measuring the performance of CW Doppler devices such as ultrasonic Doppler flowmeters, velocimeters and fetal heart detectors, and specifies the use of special Doppler test objects to determine various performance properties. This publication explicitly excludes electrical safety and acoustic output requirements and has the status of a type 2 technical report. EN 61206 is aligned with IEC 61206:1993.

Key topics

• Scope of measurement: Test methods for performance evaluation of CW Doppler systems (flowmeters, velocimeters, fetal heart detectors).
• Performance properties: Procedures to determine key functional characteristics (e.g., sensitivity, velocity detection, directional discrimination, signal stability and repeatability, and response to Doppler targets) - using standardized Doppler test objects.
• Test objects: Description and use of special Doppler test objects (phantoms or mechanical simulators) for consistent, repeatable testing across devices.
• Test procedures: Stepwise measurement approaches to collect comparable performance data for acceptance testing, calibration and R&D.
• Limitations: Does not address electrical safety, acoustic output levels or other diagnostic-ultrasound-specific safety parameters.

Applications

• Acceptance testing and commissioning of continuous-wave Doppler equipment in clinical and industrial settings.
• Routine quality control and periodic performance verification in hospitals, clinics and diagnostic labs.
• Product development, validation and production testing by manufacturers of CW Doppler flowmeters, velocimeters and fetal heart detectors.
• Independent test laboratories performing objective performance evaluations and benchmarking.

Who uses this standard

• Biomedical and clinical engineers responsible for device QA/QC.
• Medical device manufacturers and R&D teams producing CW Doppler systems.
• Calibration and test laboratories.
• Quality managers and regulatory affairs professionals preparing device documentation for conformity assessment.

Related standards

• IEC 61206:1993 (original international document, equivalent in scope).
• Other IEC/EN standards covering ultrasound device safety and acoustic output (e.g., the IEC 60601 series for medical electrical equipment and diagnostic ultrasound safety/performance standards) - note EN 61206 does not replace electrical safety or acoustic-output requirements.

EN 61206 is essential for stakeholders who need reliable, repeatable procedures to evaluate the functional performance of continuous-wave Doppler ultrasound systems and to ensure consistent device behavior across deployments.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2002
Ultrasonics - Continuous-wave Doppler systems - Test procedures (IEC
61206:1993)
Ultrasonics - Continuous-wave Doppler systems - Test procedures
Ultraschall - Dauerschall Doppler System - Prüfverfahren
Ultrasons - Ensembles à effet Doppler à ondes entretenues - Méthodes d'essai
Ta slovenski standard je istoveten z: EN 61206:1995
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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