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

Publication date:   Jan 18, 2016

General information

99.60 Withdrawal effective   Jul 16, 2024

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.60   Therapy equipment

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Scope

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).

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-1:1998/A1:2002

WITHDRAWN
EN 60601-2-1:1998

NOW

WITHDRAWN
EN 60601-2-1:2015
99.60 Withdrawal effective
Jul 16, 2024

REVISED BY

PUBLISHED
EN IEC 60601-2-1:2021

Relations

Adopted from IEC 60601-2-1:2009 IDENTICAL

Adopted from IEC 60601-2-1:2009/A1:2014 IDENTICAL