GB 9706.244-2020Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (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 2-44 of GB 9706:

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

This part replaces GB 9706.18-2006 "Medical electrical equipment Part 2: X-ray computer tomography equipment safety special Claim":

Compared with GB 9706.18-2006, the main technical changes in this part are as follows:

increased:

---Basic performance requirements (see:201:4:3);

--- The scope of application clarifies that only CT scanning devices intended for the head and body (see:201:1:1);

---Some terms have been modified and some terms have been added (see:201:3);

---Patient's release (see:201:9:2:5), tensile safety factor (see:201:9:8:2), dynamic load from human weight (see 201.9:8:3:3), the requirement for CT scanning device to provide images for radiotherapy planning (RTP) (see:201:101), out of focus Radiation limit (see 203.8: 4) and other related requirements:

edited:

---Weighted CTDI100 and other terms (see:201:3, 29:103 in GB 9706.18-2006);

--- Emergency stop of motor-driven movement (see:201:9:2:4:101:1, 22:7:101 of GB 9706.18-2006), patient support and scan the linear movement of the tracing frame (see:201:9:2:4:101:3, 22:4:101 of GB 9706.18-2006) and other relevant requirements:

This part uses the redrafting method to amend and adopt IEC 60601-2-44:2016 "Medical Electrical Equipment Part 2-44: X-ray calculation Specific requirements for basic safety and basic performance of body layer photography equipment:

The technical differences between this part and IEC 60601-2-44:2016 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", and the specific adjustments are as follows:

- Replace IEC 60601-1-2:2014 (see:201:1:3 and related provisions) with YY0505 which is equivalent to adopting international standards;

- Replace IEC 60601-1-3:2013 with GB 9706.103-2020 which is modified to adopt international standards (see:201:1:3 and related Customs provisions);

- Replace IEC 60601-1:2012 (see:201:1 and related Provisions);

- Replace IEC 61223-3-5 with GB/T 19042.5-2006 which is equivalent to the international standard (see:201:101:8:2 and related Customs provisions);

- Removed IEC 60336 because it does not appear in the main text or appendix;

- Added GB 4943.1, IEC TR60788:2004:

This section has made the following editorial changes:

---All terms are represented in bold;

---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 9706.18-2000, GB 9706.18-2006:

Medical electrical equipment Part 2-44: X-ray computed tomography 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 is GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance":

201.1.1 Scope

replace:

This part of GB 9706 specifies the special requirements for the basic safety and basic performance of X-ray computed tomography equipment:

This section applies to the basic safety and basic performance of CT scanning devices, hereinafter also referred to as CT scanning devices:

If a chapter or article clearly states that it only applies to ME equipment or ME systems, the title and the text of the chapter or article will explain: if not in this case, the relevant chapters or articles apply to both ME equipment and ME systems:

Note 1: See 4.2 of the general standard:

The scope of this part is limited to CT scanning devices intended for the head and body, which are characterized by having an X-ray source and image detector, housing it is a ring-shaped general protective cover: It includes safety requirements for X-ray generators used in CT scanning devices, including high-voltage generators and X-ray generators:

Integration of tube components:

Note 2: The requirements for X-ray generators and accessory equipment previously specified in GB 9706.3 and GB 9706.14 have been included in GB 9706.1-2020 or special Use standard: Therefore, GB 9706.3 and GB 9706.14 are not part of the 9706 standard system of X-ray computed tomography equipment:

The scope of this section does not include radiotherapy simulators and systems that do not use X-ray tubes as sources to generate images:

201.1.2 Purpose

replace:

The purpose of this section is to determine the specific requirements for basic safety and basic performance of the CT scanning device defined in:201:3:201 to ensure it is safe and specifies methods to verify that it meets these specific requirements:

Note 1: The requirements for repeatability, linearity, stability and accuracy are given, because these requirements are related to the quality and quantity of ionizing radiation generated and are limited to be considered it is a requirement to ensure safety:

Note 2: Both the compliance level and the test methods specified to determine compliance reflect the fact that the safety of the high-voltage generator has a small effect on the performance level:

The difference is not sensitive: Therefore, the number of loading factor combinations specified in the test method is limited, but these combinations selected based on experience are the situation is appropriate: It is very important to standardize the selection of loading factor combinations, so that tests performed on different occasions and locations can be performed:

Out of comparison: However, in addition to the provisions, other combinations may be equally effective technically:

Note 3: The safety concept on which this section is based is stated in the introduction to general standards and IEC TR60513:

Note 4: Regarding radiation protection, in the preparation process of this part, it has been assumed that both the manufacturer and the responsible party accept the statement in paragraph 203 of ICRP 103,:2007 the general principles of ICRP include: justification, optimization, and application of dose limits, namely:

a) The principle of justification: Any decision to change radiation exposure conditions should have more advantages than disadvantages:

b) The principle of optimization: taking into account economic and social factors, make the possibility of exposure, the size of the personal dose and the number of people exposed all should be kept as low as reasonably achievable:

c) Principles for the application of dose limits: Except for the medical exposure of patients, the total dose to any individual from a controlled source should not exceed the committee recommended limit: