GB 9706.245-2020Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (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 2-45 of GB 9706:

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

This part replaces GB 9706.24-2005 "Medical electrical equipment Part 2-45: Mammography equipment and mammography stand Special requirements for the safety of body positioning devices:

Compared with GB 9706.24-2005, the main technical changes in this part are as follows:

increased:

---The scope of application clarifies the mammography equipment including mammography equipment and mammography stereotaxic device Equipment and including mammography equipment using integrated digital X-ray image receiver or integrated fluorescence storage subsystem (See:201:1:1);

---Basic performance requirements (see table:201:101);

---Added the apparent resistance of the power supply network, average gland dose, defect detector unit, raw data, unprocessed data, comparison Degree to noise ratio (see:201:3);

---Automatic exposure control (AEC) repeatability (see 203.6:5:3:2:);

---Automatic exposure control (AEC) thickness response (see 203.6:5:3:

---Imaging performance (see 203.6:7);

---The correlation coefficient of the minimum air kerma rate in different target materials and filtration combinations is given (see 203.6:7:104:1);

---Maximum loading time requirements under a specific mode (see 203.6:7:104: 2):

edited:

---Test method for linearity of air kerma kinetic energy at the interval of loading factors (see 203.6:3:1:2, GB 9706.24-2005 50:105:4):

This part uses the redrafting method to modify and adopt IEC 60601-2-45:2015 "Medical Electrical Equipment Part 2-45: Mammary X-ray Special requirements for basic safety and basic performance of photographic equipment and mammography stereotaxic devices:" the technical differences between this part and IEC 60601-2-45:2015 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 with YY0505-2012 which is equivalent to adopting international standards (see:201:1:

Text);

- 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);

- Removed IEC 60613:2010:

This section has made the following editorial changes:

---All terms are represented in bold;

--- The original text of the international standard in:201:7:9:2:1 was "Meet local regulations", and was revised to "Comply with Chinese radiation protection regulations" in the standard conversion Requirements";

---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 9706.24-2005:

Medical Electrical Equipment Part 2-45:

Mammography equipment and mammography stereo Specific requirements for basic safety and basic performance of positioning devices

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 section applies to the basic mammography equipment including mammography equipment and mammography stereotaxic equipment Safety and basic performance, hereinafter also referred to as ME equipment:

Note 1: This includes mammography equipment that uses an integrated digital X-ray image receiver or an integrated fluorescence storage subsystem:

This section does not apply to:

---Tomographic reconstruction outside the tomosynthesis of the breast;

--- CT scanning equipment applicable to GB 9706.244-2020;

---Diagnostic console;

---Picture Archiving and Communication System (PACS);

---Non-integrated fluorescent storage reader;

---Hard copy camera;

---Film, intensifying screen and cassette;

---Computer Aided Inspection (CAD);

---Perform biopsy devices and other biopsy tools;

---Display the operation mode of partial contrast (digital mammography with enhanced contrast):

If a chapter or article is clearly applicable only to ME equipment or only to ME systems, then the title and content of the chapter or article will be written Bright: If not stated, then the relevant chapters or clauses apply to both ME equipment and ME systems:

Note 2: GB 9706.3-2000 and GB 9706.14-1997 are not part of the standard system of mammography equipment and mammography stereotaxic devices:

section:

201.1.2 Purpose

replace:

The purpose of this part is to establish basic safety and basic performance specifications for mammography equipment and mammography stereotaxic devices:

Use requirements; in order to ensure safety, it specifies the methods used to prove compliance with these requirements and provides guidance for risk management:

201.1.3 Parallel standards Supplement:

This special standard refers to Chapter 2 of the general standard and applicable parallel standards listed in:201:2 of this special standard: