Specifies particular requirements for the safety of high voltage generators of diagnostic X-ray generators operating between 10 kV and 400 kV.
Applies to high-voltage generators of medical diagnostic X-ray generators and to their subassemblies including the following : - high-voltage generators that are integrated with an X-ray tube assembly; - high-voltage generators of radiotherapy treatment simulators. The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.
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