Comitato Elettrotecnico Italiano

Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV - Second Edition
 N EN 60601-2-1

Annotation

INTRODUCTION

The use of ELECTRON ACCELERATORS for RADIOTHERAPY purposes may expose PATIENTS to danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME EQUIPMENT may also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails to contain the RADIATION adequately and/or if there are inadequacies in the design of the TREATMENT ROOM.

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 ME EQUIPMENT. It places limits on the degradation of ME 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.

Clause 201.10 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to insure ESSENTIAL PERFORMANCE is maintained to avoid an unsafe condition. TYPE TESTS that are performed by the MANUFACTURER, and/or SITE TESTS, which are not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. It is understood that SITE TESTS may or may not be required of the MANUFACTURER, per the agreement between the MANUFACTURER and end user.

Given that before installation a MANUFACTURER cannot provide SITE TEST data, data available from SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the ME EQUIPMENT at installation