Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment
|Publication Date:||1 August 1997|
|ICS Code (Therapy equipment):||11.040.60|
|ICS Code (Radiation protection):||13.280|
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).
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.
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 RADIOTHERAPY.
This Particular Standard is applicable to the manufacture and some installation aspects of GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE TESTS respectively.
This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES.