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 (English Version)

Standard No.

GB 9706.217-2020

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 9706.217-2020

Replace

GB 9706.13-2008

Scope

This section applies to the basic safety and basic performance of automatically controlled brachytherapy post-installed medical electrical equipment, hereinafter referred to as ME equipment. If a chapter or clause expressly states that it applies only to ME EQUIPMENT or only to ME SYSTEMS, the title and its contents also apply. Otherwise, this Chapter or Article applies to both ME EQUIPMENT and ME SYSTEM. Except for 7.2.13 and 8.4.1 in the general standards, there are no special requirements for the physiological functional hazards implied by ME EQUIPMENT or ME SYSTEM within the scope of this part. Note: See 4.2 of the general standard. This section applies to automatically controlled brachytherapy after-loading equipment, which ME equipment is used for the treatment and relief of diseases. This section specifies requirements: a) For automatically controlled after-loaded ME equipment 1) Contain and use only beta, gamma or neutron emitting sealed radioactive sources, or design and manufacture brachytherapy X-rays for automatically controlled after-loaded ME equipment source. 2) It can automatically send the sealed radioactive source from the source container, or the brachytherapy X-ray source from a reference position outside the patient's body to the treatment position in the source applicator, and return it from the treatment position to the source container or back to the brachytherapy Reference position of the X-ray source. 3) Designed to come into contact with patients. 4) The source driving 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. b) ME EQUIPMENT 1) When in normal use, it is operated by the operator after being properly authorized or qualified. The operator has the skills required for specific medical applications and specific clinical uses, such as remote post-loading brachytherapy; 2) Maintenance in accordance with the methods recommended in the instructions for use; 3) Regular quality assurance and calibration by qualified personnel. This section does not specify requirements for sealed radioactive sources. The design requirements for X-ray tubes used in ME equipment have been clarified in other IEC standards, such as IEC60601228:2010. The requirements of this part are based on the following assumptions: 　——The treatment plan is effective and gives appropriate treatment parameter values; 1) The general standard refers to GB9706.1-2020 "Medical Electrical Equipment Part 1: Basic Safety and Basic Safety General requirements for performance. ——— The source strength of the radioactive source used in the ME EQUIPMENT is known. In order to ensure that the ME equipment can complete the preset treatment parameters, this section specifically requires: 　——The selected radioactive source can be positioned and moved relative to the source applicator in the selected combination; 　——According to the selected The exposure time is given by a selected combination of radioactive sources; 　——ME equipment will not cause unnecessary harm to the operator or other people around.

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

GB 9706.217-2020 -All Parts