Certification and Registration
Testing Standards for Imaging and Electrophysiological Medical Devices
Category:
Imaging Equipment
GB 9706.225-2022 Medical electrical equipment — Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
GB 9706.225 specifies the basic safety and essential performance requirements for electrocardiographs defined in 201.3.63, which provide diagnostic electrocardiogram reports either as standalone equipment or as part of an ME system (hereinafter referred to as ME equipment).
GB 9706.225 does not apply to the following:
a) ME equipment that provides electrocardiographic vector loops;
b) Ambulatory electrocardiographic equipment specified in YY 9706.247 that is not intended to generate diagnostic ECG reports;
c) Electrocardiographic monitors specified in GB 9706.227 that are not intended to generate diagnostic ECG reports.
ME equipment includes:
a) Direct-recording electrocardiographs;
b) Other ME equipment that provides diagnostic ECG reports, such as patient monitors, defibrillators, and exercise testing equipment;
c) Electrocardiographs that can be used remotely from the patient (for example, through telephone lines, networks, or storage media). In such cases, the transmission medium, ME equipment, or ME system falls within the scope of this document.
GB 9706.226-2021 Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
GB 9706.226 specifies the basic safety and essential performance requirements for electroencephalographs defined in 201.3.63 (hereinafter referred to as ME equipment).
GB 9706.226 applies to ME equipment used in clinical environments, such as hospitals and doctors’ offices.
GB 9706.226 does not apply to other devices used in electroencephalography, including:
— Audio-visual stimulators;
— Telemetric electroencephalographs;
— Equipment for storing and reproducing electroencephalographic data;
— ME equipment specifically intended for monitoring during electroconvulsive therapy;
— Ambulatory electroencephalographs.
GB 9706.237-2020 Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
GB 9706.237 applies to ultrasonic diagnostic equipment defined in 201.3.217 (hereinafter referred to as ME equipment) and specifies its basic safety and essential performance requirements.
If a particular provision or clause is intended to apply only to ME equipment or only to ME systems, this shall be clearly specified in the title or text of the relevant clause. Otherwise, the clause shall apply to both ME equipment and ME systems.
GB 9706.237 does not cover inherent risks associated with the intended physiological functions of ME equipment or ME systems within its scope, except where specifically addressed in this standard, including 7.2.13 and 8.4.1.
GB 9706.237 does not apply to ultrasonic therapeutic equipment. However, equipment using ultrasound for imaging or diagnosing human anatomical structures is included when used in combination with other medical procedures.
YY 6906.240-2024 Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017
YY 6906.240 provides guidance on the application of quality management system requirements specified in YY/T 0287-2017 for medical devices.
GB 9706.243-2024 Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional X-ray equipment
GB 9706.243 applies to X-ray equipment for interventional procedures (hereinafter referred to as interventional X-ray equipment) that manufacturers claim is suitable for fluoroscopy-guided interventional procedures.It specifies the basic safety and essential performance requirements for such equipment.
GB 9706.244-2020 Medical electrical equipment — Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography equipment
GB 9706.245-2020 Medical electrical equipment — Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographic stereotactic devices
YY 9706.247-2021 Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
YY 9706.247-2021 specifies the particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
YY 9706.247-2021 applies to ambulatory electrocardiographic systems regarding their basic safety and essential performance.
The following types of systems are within the scope of YY 9706.247-2021:
a) Systems capable of continuously recording and analyzing electrocardiograms and producing substantially identical results when the ECG is completely reanalyzed. Such systems may record and store ECG data for later analysis by a separate unit or perform recording and analysis simultaneously. This standard does not specify requirements for the type of storage medium used.
b) Systems capable of continuous analysis with only partial or limited recording capability. Such systems cannot perform complete ECG reanalysis.
Systems meeting any of the above categories shall comply with the safety requirements specified in this standard. If an ambulatory electrocardiographic system provides automated ECG analysis, it shall comply with the minimum performance requirements for measurement and analysis functions specified in this standard.
This standard does not apply to systems that cannot continuously record and analyze ECGs, such as intermittent event recorders.
GB 9706.254-2020 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and basic performance of X-ray radiography and fluoroscopy equipment
SATISFY provides one-stop testing services for imaging and electrophysiological medical devices, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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