Standards Development

Scope

This document applies to medical electron accelerators (3.16) when used, for therapy purposes, in human medical practice.

This document applies to medical electron accelerators (3.16) which deliver a radiation beam (3.62) of either X-radiation (3.99) or electron radiation (3.21) with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates (3.2) between 0,001 Gy s−1 and 1 Gy s−1 at the ERP from the radiation source (3.68) and at normal treatment distances (3.46) between 0,5 cm and 2 m from the radiation source (3.68).

The present standard describes measurements and test procedures to be performed by the manufacturer (3.42) at the design and construction stage of a medical electron accelerator (3.16) it and does not specify acceptance tests (3.3) to be performed after installation at the purchaser's site, but test procedures have been chosen to align with those appropriate for acceptance tests (3.3).

This document specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator (3.16) and which are to be declared in the accompanying documents (3.5) together with the deviation or variation from the declared values to be expected under specific conditions in normal use (3.48). A format for presentation of functional performance values is given in Annex A.

It is recognized that uncertainties in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved.

It is not intended that this document should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment (3.91) of patients (3.50).

Except where otherwise stated, this document assumes that the medical electron accelerators (3.16) have an isocentric (3.37) gantry (3.29). Where the equipment is non-isocentric (3.37), the description of performance and test methods may need to be suitably adapted.

NOTE A statement of compliance with this document does not necessarily imply that these tests will be or have been applied as type tests (3.92) or as individual tests.