IEC 62274 pdf download Medical electrical equipment – Safety of radiotherapy record and verify systems
1 scope and object1.1 Scope
This International Standard applies to the design and manufacture and some installationaspects of a RECORD AND VERIY SYSTEM (Rvs) for use in RADIOTHERAPY in human medicalpractice that
a) provides,defines,or displays treatment machine set up data; imports data either throughinput 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 lINSTRUCTIONS 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.
lt does,however,address certain specific aspects of the connection of the RVS to a networkor to other radiotherapy equipment, and the communication protocol to be used.
This standard applies to any RVS and establishes the requirements for features, associateddocumentation, and testing of the software.Requirements for SAFETY of hardware are notincluded in this standard,as these vary with the nature of the hardware (see 1.3.1 andAnnex A concerning hardware requirements).
An RVS developed by a usER exclusively for the uSER’s own use is not within the scope of thisstandard,but it is highly recommended that the principles of this standard be applied in itscreation and use. If this technology is provided to another usER under conditions in which thedevelopers do not directly control its use,and is represented as being suitable for use,thenthe developers assume the role of MANUFACTURER and this standard applies.
1.3 Relationship to other standards
1.3.1 Hardware SAFETY standards Requirements for SAFETY of hardware, such as for protection against electric shock, fire, and for ELECTROMAGNETIC COMPATIBILITY , are not included in this document. S AFETY requires that these subjects be addressed by the MANUFACTURER separately through compliance with an appropriate standard, depending upon the nature and environment of the hardware used for the RVS (see Annex A for hardware SAFETY standards).
1.3.2 Software SAFETY standards
All clauses and subclauses of the collateral standard IEC 60601 -1 -4 (see 4.1 ) apply.
In applying IEC 60601 -1 -4, the MANUFACTURER shall consider hazards that could occur due to use errors associated with the RVS.
NOTE IEC 60601 -1 -6 describes a process for the risk management of use errors.