GB 9706.217-2020Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy after loading equipment (English PDF)

Foreword

GB 9706 "Medical Electrical Equipment" is divided into the following parts:

---Part 1: General requirements for basic safety and basic performance;

---Part 1-3: General requirements for basic safety and basic performance Parallel standard: Radiation protection of diagnostic X-ray equipment;

---Part 2-1: Specific requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV;

---Part 2-2: Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;

---Part 2-3: Special requirements for basic safety and basic performance of short-wave treatment equipment;

---Part 2-4: Special requirements for the basic safety and basic performance of cardiac defibrillators;

---Part 2-5: Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;

---Part 2-6: Special requirements for the basic safety and basic performance of microwave therapy equipment;

---Part 2-8: Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;

---Part 2-11: Special requirements for basic safety and basic performance of gamma beam therapy equipment;

---Part 2-12: Special requirements for the basic safety and basic performance of intensive care ventilators;

---Part 2-13: Special requirements for basic safety and basic performance of anesthesia workstations;

---Part 2-16: Specific requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;

---Part 2-17: Special requirements for basic safety and basic performance of automatic control brachytherapy after-installation equipment;

---Part 2-18: Specific requirements for basic safety and basic performance of endoscopic equipment;

---Part 2-19: Special requirements for basic safety and basic performance of infant incubators;

---Part 2-22: Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;

---Part 2-24: Specific requirements for basic safety and basic performance of infusion pumps and infusion controllers;

---Part 2-25: Special requirements for basic safety and basic performance of electrocardiograph;

---Part 2-26: Specific requirements for the basic safety and basic performance of EEG machines;

---Part 2-27: Special requirements for basic safety and basic performance of ECG monitoring equipment;

---Part 2-28: Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;

---Part 2-29: Specific requirements for the basic safety and basic performance of radiotherapy simulators;

---Part 2-36: Specific requirements for the basic safety and basic performance of in vitro lithotripsy equipment;

---Part 2-37: Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;

---Part 2-39: Specific requirements for the basic safety and basic performance of peritoneal dialysis equipment;

---Part 2-43: Special requirements for the basic safety and basic performance of interventional X-ray equipment;

---Part 2-44: Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;

---Part 2-45: The basic safety and basic performance of mammography equipment and mammography stereotaxic devices Claim;

--- Part 2-54: Specific requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;

---Part 2-60: Special requirements for basic safety and basic performance of dental equipment;

---Part 2-63: Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;

---Part 2-65: Specific requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;

---Part 2-66: Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system:

This part is part 2-17 of GB 9706:

This section was drafted in accordance with the rules given in GB/T 1.1-2009:

This part replaces GB 9706.13-2008 "Medical electrical equipment Part 2: Safety of automatic control brachytherapy after-installation equipment Dedicated requirements: Compared with GB 9706.13-2008, the main technical content changes are as follows:

---Medical electrical equipment is collectively referred to as ME equipment;

--- Added the definition of after-installation (see:201:3:1);

---Modified the definition of brachytherapy (see:201:3:4, 2:1:103 in the:2008 edition);

--- Added the definition of photon source intensity (see:201:3:9);

--- Added:201:10:1, which specifies the basic safety and basic performance requirements of X-ray source after-installation equipment (see:201:10:1):

This part uses the redrafting law to amend and adopt IEC 60601-2-17:2013 "Medical Electrical Equipment Part 2-17: Automatic Control Special requirements for basic safety and basic performance of brachytherapy after-installation equipment:" the technical differences between this part and IEC 60601-2-17:2013 and the reasons are as follows:

---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments:

The situation is collectively reflected in:201:2 "Normative Reference Documents":

- Replace IEC 60601-1:2012 (see:201:2 and related provisions) with GB 9706.1-2020 which is modified to adopt international standards;

- ISO 361 has been added:

This section has made the following editorial changes:

---The term index of the international standard has been deleted:

Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:

This part is proposed and managed by the State Drug Administration:

The previous versions of the standards replaced by this part are as follows:

---GB 9706.13-1997, GB 9706.13-2008:

Introduction

The process of radiotherapy in a short distance is called brachytherapy: Brachytherapy treats by placing a radiation source in or near the tissue Treatment: Historically, the manual operation of the radioactive source caused the operator's hand to be irradiated: After loading usually refers to placing the applicator in or near the After confirming the location of the applicator, the treated tissue introduces one or more radioactive sources for treatment: This process makes the operator suffer the radiation source has the shortest exposure time: Manual afterloading technology was developed in the 1950s, and is currently usually used for permanent implantation, rarely used for temporary implantation:

Temporary implantation requires a higher dose rate to ensure that the patient can tolerate and complete the treatment during the treatment period: In the 20th century in the 1980s, automatic long-distance afterloading technology was developed to move one or more radioactive sources from the source storage device to the patient through the connecting pipe:

Inside the applicator: Because radioactive sources can move long distances, the risk of exposure to personnel can be ignored:

In:2007, an automatic control remote after-installation machine using X-ray sources instead of traditional radioactive sources appeared:

The after-installation function of the radioactive source is similar: The X-ray source can be turned off when not in use, eliminating the risk of radiation: In addition to the requirements of this section, make Brachytherapy equipment using X-ray sources complies with the requirements of IEC 60601-2-8:

If the ME device for brachytherapy fails to give the patient the prescribed dose or the design of the ME device does not meet the safety of the ME device Standard requirements, then the use of ME equipment will cause harm to patients: If the ME equipment itself fails to adequately shield the radioactive source in the source reservoir, the X-ray tube is inappropriately excited, or the shielding design of the treatment room is not sufficient, the ME equipment may also cause the ME equipment Personnel near the equipment were damaged:

This part determines the requirements that manufacturers should follow when designing and manufacturing after-installation ME equipment for temporary brachytherapy procedures, but it does not specify the optimal performance requirements of ME equipment: Its purpose is to determine the design of functional components related to the basic safe operation of ME equipment:

meter: This section sets limits on the performance degradation of ME equipment: When the limit is exceeded, it can be considered that there is a fault state:

The activation of the lock device can stop the X-ray tube or return the radioactive source to the source reservoir, and then prevent the ME equipment from continuing to operate:

Medical Electrical Equipment Part 2-17:

Automatic control brachytherapy after-installation equipment Special requirements for basic safety and basic performance

201.1 Scope, purpose and related standards in addition to the following, Chapter 1 of the general standard 1) applies:

1) The general standard refers to GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance":

201.1.1 Scope

replace:

This section applies to the basic safety and basic performance of medical electrical equipment installed after automatic control brachytherapy, hereinafter referred to as ME equipment:

If the chapter or article clearly states that it is only applicable to ME equipment or only to ME systems, the title and its content also apply: Otherwise, the Chapters or articles are applicable to both ME equipment and ME systems:

Except for 7:2:13 and 8:4:1 in the general standard, there is no implied physiological function for ME equipment or ME system within the scope of this part:

Can harm to make special requirements:

Note: See 4.2 of the general standard:

This section applies to automatic control brachytherapy afterloading equipment, the ME equipment used for disease treatment and relief:

The requirements of this section:

a) For automatically controlled after-installed ME equipment

1) Contain and use only beta, gamma or neutron emission sealed radioactive sources, or design and manufacture for automatic control of after-installation ME equipment Brachytherapy X-ray source:

2) It can automatically remove the sealed radioactive source from the source container, or the brachytherapy X-ray source from a reference position outside the patient's body, Send to the treatment position in the applicator and return from the treatment position to the source reservoir or return to the reference of the brachytherapy X-ray source position:

3) Designed to be in contact with patients:

4) 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: control the timer or timing device can be a programmable electronic subsystem PESS (computer or microprocessor), or it can be Programming electronic system:

b) ME equipment

1) In normal use, the operator shall perform the operation after being appropriately authorized or qualified by qualified personnel: Operators have special Determine the skills required for medical applications and specific clinical uses, such as remote afterloading brachytherapy;

2) Maintain according to the method recommended in the instruction manual;

3) Regular quality assurance and calibration by qualified personnel:

This part does not specify requirements for sealed radioactive sources: The design requirements of X-ray tubes used in ME equipment are in other IEC standards it has been clear, such as IEC 60601-2-28:2010:

The requirements of this section are based on the following assumptions:

---The treatment plan is effective and gives appropriate treatment parameter values;