This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-2-11:1997, (second edition, 1997-08). 1 Scope and Object This clause of the General Standard applies as follows: 1.1 Scope Addition: aa)
This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY EQUIPMENT intended for RADIOTHERAPY in human medical practice and includes EQUIPMENT in which the selection and DISPLAY of operating parameters can be controlled by a PROGRAMMABLE ELECTRONIC SYSTEM (PES). bb)
This Particular Standard applies to EQUIPMENT which is intended to deliver a GAMMA RADIATION BEAM(S) at NORMAL TREATMENT DISTANCES greater than 5 cm using a SEALED RADIOACTIVE SOURCE(S). For EQUIPMENT operating at shorter distances, special precautions may be necessary. cc)
This Particular Standard applies to EQUIPMENT intended to be: -used under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the skills required for a particular medical application and acting in accordance with the INSTRUCTIONS FOR USE, -maintained at predetermined intervals, -subject to regular checks by the USER, -used for particular specified clinical purposes e.g. STATIONARY RADIOTHERAPY or MOVING BEAM THERAPY. dd)
This Particular Standard is applicable to the manufacture and some installaton aspects of GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE TESTS respectively. ee)
This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES. 1.2 Object Addition: aa)
This Particular Standard establishes requirements to ensure the RADIATION safety and enhance the eletrical and mechanical safety of GAMMA BEAM THERAPY EQUIPMENT used in human medical practice and specifies tests for demonstrating compliance with those requirements. bb)
In EQUIPMENT of the type covered by this Standard, ABSORBED DOSE* is controlled by the time of IRRADIATION. Tolerances for other methods of controlling the ABSORBED DOSE are not included in this standard.