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IEC 60601-2-1:2009+AMD1:2014 CSV

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

Üldinfo
Kehtetu alates 28.10.2020
Tegevusala (ICS grupid)
11.040.60 Raviseadmed
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
28.10.2020
Põhitekst
21.07.2014
Põhitekst
IEC 60601-2-1:2009+A1:2014 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. 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). This consolidated version consists of the third edition (2009) and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication.
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