This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-2-8:1987 + A.1:1997, (edition 1.1, 1999-04). 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition:
This Particular Standard applies to therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kv to 1 MV when connected to alternating current SUPPLY MAINS. 1.2 Object Replacement:
This Particular Standard establishes requirements for the safety of therapeutic X-RAY EQUIPMENT including the requirement for accuracy and reproducibility of performance to the extent that these are related to RADIATION QUALITY and the quantity of IONIZING RADIATION produced and thus must be considered as aspects of safety. An object of this Particular Standard is to present the general functional requirements of the demand for safety, rather than any particular technological means of implementation.