Medical electrical equipment. Safety of radiotherapy record and verify systems (IEC 62274:2005)
1.1 Scope This International Standard applies to the design and manufacture and some installation aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the OPERATOR or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all TREATMENT sessions; and d) is intended to be: 1) for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; 2) maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE; and 3) used within the environmental and electrical supply conditions specified in the technical description. This standard does not address dynamic beam deliveries. NOTE This may be addressed in a future version of this standard. It does, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used. 1.2 Object This standard applies to any RVS and establishes the requirements for features, associated documentation, and testing of the software. Requirements for SAFETY of hardware are not included in this standard, as these vary with the nature of the hardware (see 1.3.1 and Annex A concerning hardware requirements). An RVS developed by a USER exclusively for the USER’S own use is not within the scope of this standard, but it is highly recommended that the principles of this standard be applied in its creation and use. If this technology is provided to another USER under conditions in which the developers do not directly control its use, and is represented as being suitable for use, then the developers assume the role of MANUFACTURER and this standard applies.
: 7 470,0 Ft
(papír , PDF-fájl-letöltés)
Jelenleg nincsenek előzmények
Jelenleg nincsenek utódok