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 (English Version)

Standard No.

GB 9706.5-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2023-05

Replace By

GB 9706.201-2020

Latest

GB 9706.201-2020

Replace

GB 9706.5-1992

Scope

This section includes type tests and field tests, respectively applicable to the manufacture of electron accelerators ¹⁾ and certain installations ²⁾: - intended for use in radiation therapy in human medical practice, including energy Equipment whose selection and display of operating parameters are automatically controlled by a programmable electronic subsystem (PESS); - under normal conditions (NC) and in normal use, the X-radiation beam and/or electron radiation beam output by the equipment: The nominal energy is 1MeV to 5OMeV; The maximum absorbed dose ³⁾ rate is between 0.001Gy S^-1 and 1Gy S^-1 at lm away from the radiation source; Normal treatment distances (NTDs) between 0.5m and 2m from the source of radiation; - while for normal use, under the direction of an appropriate licensed or qualified person, operated by an operator with the skills required for the particular medical application , for specific clinical purposes: i.e. fixed radiotherapy or moving beam radiotherapy; Maintained as recommended in the instructions for use; Periodic inspections for quality assurance and calibration by qualified personnel; Environmental conditions specified in the technical instructions and power conditions are used.

GB 9706.5-2008 history

• 2020 GB 9706.201-2020 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
• 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
• 1992 GB 9706.5-1992 Medical electrical equipment.Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV

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 was changed to GB 9706.201-2020 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV.

GB 9706.5-2008 -All Parts