GB 9706.5-2008 Medical electrical equipment—Part 2-1:particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV

Scope

Addition:
This section includes type tests and field tests, which are applicable to the manufacture of electronic accelerators 1) and certain installation situations 2):
——Intended for use in radiation therapy in human medical practice, including devices capable of automatically controlling and displaying their operating parameters by a programmable electronic subsystem (PESS);
——Under normal conditions (NC) and during normal use, the X-ray beam and/or electron beam output by the device:
●With a nominal energy of 1 MeV to 50 MeV;
●At a distance of 1 m from the radiation source, the maximum absorbed dose rate 3) is between 0.001 Gy·s-1 and 1 Gy·s-1;
●With a normal treatment distance (NTDs) between 0.5 m and 2 m from the radiation source;
——At the same time
●For normal use, it is operated by operators with the skills required for special medical applications under the guidance of relevant licensed or qualified personnel, for specific clinical purposes: namely fixed radiation therapy or mobile beam radiation therapy;
●Maintained according to the methods recommended in the user manual;
●Regularly subjected to quality assurance and calibration tests by qualified personnel;
●Used under the environmental and power supply conditions specified in the technical specifications.

Development Information

Same series standard

Replace the following standards

Superseded by the following standards

Adopt standards

Related Standards