Skip to main content
Back

EVS-EN 60601-2-11:2015

Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

General information

Valid from 08.06.2015
Base Documents
IEC 60601-2-11:2013; EN 60601-2-11:2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.06.2015
Main
10.12.2004
Amendment
01.07.2001
Main
IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN IEC 60601-2-28:2019

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Newest version Valid from 15.10.2019
Main

EVS-EN 60601-2-68:2015

Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
Newest version Valid from 02.07.2015
Main + amendment

EVS-EN 60601-2-44:2009+A11+A1+A2

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Newest version Valid from 02.08.2017
Main

EVS-EN 60601-2-29:2009

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
Newest version Valid from 05.02.2009