IEC TS 62462-2017 pdf free.Ultrasonics – Output test – Guidance for the maintenance of ultrasound physiotherapy systems.
This document, which is a Technical Specification, describes methods meant to assist users of ultrasound physiotherapy systems in checking the performance of such systems. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors. osteopaths, beauty therapists, sports professionals. biomedical engineers, medical physicists. medical device service agents. commercial testers, test houses or manufacturers. Typical ultrasound physiotherapy systems operate in the range from 0,5 MHz to 5 MHz Long-wave ultrasound therapy machines operating in the trequency range 30 kHz to 0.5 MHz are not covered by this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE The titles 01 all publications referred to informatively in this document are listed in the Bibliography.
IEC 60601-2-5:2009, Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 61161:2013, Ultrasonics — Power measurement — Radiation force balances and performance requirements
IEC 61689:2013, Ultrasonics — Physiotherapy systems — Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at
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NOTE Most of the definitions in Clause 3 are taken from existing IEC standards. They have been simplified for the purposes of this document.
acoustic working frequency rate at which the treatment head’s contact face is vibrating.
4.1 Acceptance testing After the device has been delivered to the user a first test should be performed to record the performance at the start of the devices lifetime. See Annex A for rationale.
4.2 Weekly testing Weekly qualitative testing is performed by the therapy machine user, e.g. physiotherapist, general medical practitioner, chiropractor, osteopath, beauty therapist, sports professional. See Annex A for rationale.
4.3 Annual testing Annual testing is performed by an accredited tester, e.g. biomedical engineer, medical physicist, medical device service agent, commercial tester, test house, national measurement institute, manufacturer. See Annex A for rationale.
5 Performance testing
5.1 Acceptance testing
5.1.1 General
The purpose of the test is to record the performance of a device before clinical use, or of a device that has been repaired. The test involves a manufacturer’s statement, a visual inspection and a quantitative relative ultrasonic output test. See Annex B for guidance for testers,
5.1.2 Visual Inspection The first visual inspection should concentrate on the delivered items. All items should have been delivered in accordance with the purchase specification, and they should look undamaged.
5.1.3 Manufacturer’s statement
On delivery of a new device or after repair of an existing device, check the written system manufacturer’s statement that the device performs in accordance with the manufacturer’s device specifications. From this statement, it follows that the device shall be traceably calibrated in accordance with lEG 61689 and lEG 60601-2-5.IEC TS 62462 pdf download.