94/508290 DC-1994BS 5724 Part 2 Section 2.11:1989BS 5724-2.11.1:1989BS 5724-2.11.2:1993
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 RADIOTHERAPY.
dd)
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.
ee)
This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES.
BS EN 60601-2-11:1998 history
2015BS EN 60601-2-11:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
1998BS EN 60601-2-11:1998 Medical electrical equipment - Particular requirements for the safety - Specification for gamma beam therapy equipment