CAN/CSA-C22.2 No. 60601-2-1-01 (R2009)

This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-2-1:1998, (second edition, 1998-06). 1 Scope and object 1.1 Scope This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation* aspects Of ELECTRON ACCELERATORS** - intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), -that, under NORMAL CONDITIONS (Nc) and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION and/or ELECTRON RADIATION having - NOMINAL ENERGY in the range 1 MeV to 50 MeV, - maximum ABSORBED DOSE*** RATES between 0,001 Gy x s-1 and 1 Gy x s-1 at 1 m from the RADIATION SOURCE, - NORMAL TREATMENT DISTANCES (NTDS) between 0,5 m and 2 m from the RADIATION SOURCE, and - intended to be - for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, - maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, - subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON, - used within the environmental and electrical supply conditions SPECIFIED in the technical description. 1.2 Object Addition: This Particular Standard establishes requirements to ensure the IONIZING RADIATION safety and enhanced electrical and mechanical safety of ELECTRON ACCELERATORS, and specifies tests to check compliance with those requirements NOTE - The adoption of this standard helps to ensure that the EQUIPMENT - maintains PATIENT safety during EQUIPMENT movements and failure of the SUPPLY MAINS, - delivers the pre-selected RADIATION TYPE, NOMINAL ENERGY, and ABSORBED DOSE. - delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT, by utilizing STATIONARY RADIOTHERAPY, MOVING BEAM RADIOTHERAPY, RADIATION BEAM modifying devices, etc. without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.