IEC TS 62462 Edition 2.0 2017-07

Ultrasonics - Output Test - Guide For The Maintenance Of Ultrasound Physiotherapy Systems

TS 62462 Edition 2.0 2017-07

Standard Organization: IEC

IEC TS 62462 Edition 2.0 2017-07
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems

Recognition Number	Radiology
Recognition Date	2018-06-07
Recognition List	049
Recognition Number	12-313
Extent	Complete standard
Standards Orgs	IEC International Electrotechnical Commission http://www.iec.ch/
STG	Radiology
FDA Tech	Subha Maruvada FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2524 subha.maruvada@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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 frequency range 30 kHz to 0,5 MHz are not covered by this document.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§890.5300	Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat	Class 3	LXF
§890.5300	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Class 2	PFW
§890.5300	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Class 2	IMI
No product code information listed for §1050.10

FDA Guidance:

Recognized Consensus Standards

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Recognized Consensus Standards