GB 9706.13-2008
Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (English Version)

Standard No.

GB 9706.13-2008

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 9706.217-2020

Latest

GB 9706.217-2020

Replace

GB 9706.13-1997

Scope

Except for the following modifications, the provisions of GB9706.1-2007 "Requirements for Medical Electrical Equipment") apply. Part 1: General Safety Requirements (hereinafter referred to as "General Application Scope and Purpose of Safety") This chapter of "General Safety Requirements" applies except for the following modifications. Safety requirements for automatically controlled equipment for treatment. 1.1.102 This part specifies the requirements for automatically controlled afterloading equipment, which contains and only enables users to seal radioactive sources of β, γ and neutrons; The source is delivered from the source reservoir to the treatment position in the source applicator and returned from the treatment position to the source reservoir; - designed to be in contact with the patient; - the source drive mechanism should be controlled by a control timer or timing device according to a preset program , to automatically complete the movement of the radioactive source. The control timer or timing device can be a programmable electronic subsystem PESS (computer or microprocessor), or a non-programmable electronic system. 1.1.103 The requirements of this section require equipment—— Use under the supervision of qualified personnel; - regular maintenance; - regular inspection by the user. This part does not specify the requirements for sealed radioactive sources used, and the requirements for sealed radioactive sources are specified by other standards (see 6.8.3). 1.1 .104 The requirements of this part are based on the following assumptions: - The treatment plan is valid and gives appropriate treatment parameter values; - The source strength of the radioactive source used by the equipment is known. Parameters, this part specifically requires: - the selected radioactive source can be positioned and moved relative to the source applicator in the source applicator according to the selected combination; - according to the selected irradiation time, given by the selected combination of radioactive sources Irradiation; - The equipment will not cause unnecessary harm to the operator or other people around.

GB 9706.13-2008 history

• 2020 GB 9706.217-2020 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
• 2008 GB 9706.13-2008 Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
• 1997 GB 9706.13-1997 Medical electrical equipment--Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment

GB 9706.13-2008 Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment was changed to GB 9706.217-2020 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment.

GB 9706.13-2008 -All Parts