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 (English Version)

Standard No.

GB 9706.201-2020

Language

Chinese, Available in English version

Release Date

2020

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB 9706.201-2020

Replace

GB 9706.5-2008

Scope

This section applies to the basic safety and basic performance of therapeutic electron accelerators with energies from 1 MeV to 50 MeyVy, hereinafter referred to as ME equipment. This section includes type testing and field testing, respectively applicable to the manufacture and certain installation aspects of electron accelerators: 　——intended for use in radiotherapy in human medical practice, including the ability to automatically control it by a programmable electronic subsystem (PESS) Equipment for selection and display of operating parameters. ——Under normal conditions and during normal use, the X-ray beam and/or electron radiation beam output by this equipment: Nominal energy 1 MeV to 50 MeV:; Maximum absorption at 1 m from the source Dose rates are between 0.001 Gy"s and 1Gy'"s; normal therapeutic distances (CNTDs) are between 0.5m and 2m from the radiation source. Also, - is intended to be used: for normal use, by operators with the skills required for specific medical applications, under the direction of appropriately licensed or qualified personnel, for specific clinical purposes, such as fixed radiotherapy or mobile Beam radiotherapy equipment is maintained as recommended in the instructions for use; quality assurance and calibration inspections are performed regularly by qualified personnel. Note 1: In this section, all installations referred to refer to installations at the location of the responsible party. Note 2: All references to absorbed doses in this section refer to absorbed doses in water. GB/T 18987-2015 gives guidance on the naming of equipment movements, identification of scales, their zero positions and the direction of increasing values of movement (see 201.7.4.101). GB 15213 specifies methods for testing and publishing the functional characteristics of medical electron accelerators. The purpose of this standard is to facilitate comparison between accelerator-based ME equipment from different manufacturers. GB 15213 does not include safety requirements and therefore does not need to be consistent with this part. In addition, it should be noted that the tests specified in GB 15213 do not guarantee that a medical electron accelerator will meet the claimed functional characteristics during its working life.

GB 9706.201-2020 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 9706.201-2020 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 has been changed from 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.

GB 9706.201-2020 -All Parts