Skip to main content
Back

EVS-EN 60601-2-1:2015

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

General information

Withdrawn from 03.08.2021
Base Documents
EN 60601-2-1:2015; IEC 60601-2-1:2009; IEC 60601-2-1:2009/A1:2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.08.2021
Main
04.11.2015
Main
01.01.2003
Main
IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions: - alignment with the new relevant collateral standards; - new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

Required fields are indicated with *

*
*
*
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

Main

EVS-EN 61217:2012

Radiotherapy equipment - Coordinates, movements and scales
Newest version Valid from 03.05.2012
Main

EVS-EN 62083:2010

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Newest version Valid from 08.04.2010
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

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
Newest version Valid from 08.06.2015