Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Clause 1 of the general standard1 applies, except as follows:

201.1.1 Scope

Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging.

Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

NOTE This document is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and XRAY TUBE HEADS.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for X-RAY TUBE ASSEMBLIES for medical diagnosis.