Back

EVS-EN 60601-2-62:2015

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

General information
Valid from 08.06.2015
Base Documents
IEC 60601-2-62:2013; EN 60601-2-62:2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.06.2015
Main
IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to  - therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;  - therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;  - and equipment intended to be used for relieving cancer pain due to bone metastases.  This particular standard does not apply to  - Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689);  - Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36);  - Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and  - Ultrasound Equipment intended to be used for phacoemulsification.
*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Amendment

EVS-EN 60601-2-37:2008/A1:2015

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Newest version Valid from 02.09.2015
Main + amendment

EVS-EN 60601-1:2006+A1+A12+A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, modified + A1:2013 + A12:2014 + IEC 60601-1:2005/A2:2020)
Newest version Valid from 01.11.2021
Main

EVS-EN 60601-2-5:2015

Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
Newest version Valid from 04.11.2015
Main

EVS-EN 62435-5:2017

Electronic components - Long-term storage of electronic semiconductor devices - Part 5: Die and wafer devices
Newest version Valid from 18.04.2017