GB 9706.5-2008
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
Abstract
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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Replaced |
| Standard Code | GB 9706.5-2008 |
| CCS | Medical radiation equipment |
| ICS | Treatment equipment |
| Implement Date | 2010-02-01 |