EN 60601-2-5

Area	Medical technology
title	Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
Latest edition	12.2001
ISO	IEC 60601-2-5: 2000

The EN 60601-2-5 with the title "Medical electrical devices - Part 2-5: Special specifications for the safety of ultrasonic physiotherapy devices" is part of the EN 60601 series of standards .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-5 .

The standard is based on the international version IEC 60601-2-5. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-5 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for ultrasound physiotherapy equipment.

validity

The German edition 12.2001 is accepted as a German standard with its date of issue .

Attention: In March 2008 a new draft was published.
The current version (12.2001) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
Draft 3.2008 is to be used in accordance with the 3rd edition of DIN EN 60601-1.

scope of application

“These special stipulations define requirements for the safety of ultrasonic physiotherapy devices for medical use, (...). These special provisions do not apply to:

Devices in which a tool is driven by ultrasound (for example devices for use in surgery and dentistry);
Devices in which focused ultrasonic pulse waves are used to destroy kidney or bladder stones ( lithotripsy ), for further information refer to EN 60601-2-36 ;
Ultrasound physiotherapy devices that use focused ultrasound pulse waves. "

extra information

The following changed requirements are contained in EN 60601-2-25 (extract):

Interference immunity (EMC)
Release of energy (ultrasound, heat)
Protection against dangerous output values