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) that deliver a radiation beam (3.61) of either X-radiation (3.97) or electron radiation (3.21) with which deliver a radiation beam of either X-radiation (specified by nominal accelerating potential, 1-50 MV) or electron radiation (specified by nominal energy, 1-50 MeV) at maximum absorbed dose rates (3.2) between 0,001 Gy s−1 and 1 Gy s−1 at the ERP equipment reference point (3.24) from the radiation source (3.67) and at normal treatment distances (3.46) between 0,5 m and 2 m from the radiation source (3.67).NOTE 1 This document applies to conventional dose-rates up to 1 Gy·s⁻¹. Ultra-high dose-rate (FLASH) operation is outside the scope and shall be characterized separately by the manufacturer.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 does not prescribe 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 that 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. As far as possible test methods described do not focus on the measurement errors but the equipment deviations, this in the expectation that more accurate test methods will be developed over time.It is not intended that this document should in any way inhibit the future development of new designs of equipment that can have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment (3.89) 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 can be suitably adapted, any such adpation shall be desbribed by the manufacturer.NOTE 2 A statement of compliance with this document does not necessarily imply that these tests will be or have been applied as type tests (3.90) or as individual tests.