Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
|Publication Date:||1 May 2002|
|ICS Code (Therapy equipment):||11.040.60|
This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation1) aspects of ELECTRON ACCELERATORS2)
- 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 DOSE3) 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,
- 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) In this Particular Standard, all references to installation refer to installation in the USER'S premises.
2) See ICRP 33 (128) - (134) and (144) - (156).
3) In this Particular Standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.