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IEC 60601-2-1 Ed. 3.0 Edition 10/2009
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
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Abstract

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).

Status

Standard - Active

Origin

Technical Committee :
62C : Equipment for radiotherapy, nuclear medicine and radiation dosimetry

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
IEC 60951-3 Ed.3.0 RLV
IEC 60601-2-1 Ed.4.0

Relations to older standards
IEC 60601-2-1 am1 Ed. 2.0
IEC 60601-2-1 Ed. 2.0

International Classification for Standards (ICS codes) :

11.040.60 : Therapy equipment

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