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About This Item

 

Full Description

BS EN 60601-2-5:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.

This standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD.

This standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability.

In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular standard specifying safety requirements for the additional function.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME 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.


Cross References:
IEC 60601-1-2:2007
EN 60601-1-2:2007
EN 60601-1-2:2007/Corrigendum 1:2010
IEC 61689:2007
EN 61689:2007
IEC 62127-1:2007
EN 62127-1:2007
IEC 62127-2:2007
EN 62127-2:2007
IEC 60601-2-36:1997
EN 60601-2-36:1997
IEC 61161:2006
EN 61161:2007
93/42/EEC
IEC 62462:2007
ISO/IEC Guide 98:2007
IEC 60050-802
IEC 60469-1:1987


Replaces BS EN 60601-2-5:2001 which remains current

All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN 60601-2-5:2015

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    Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

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  2. BS EN 60601-2-5:2001


    Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of ultrasonic physiotherapy equipment

    • Historical Version