Medical Imaging Equipment Testing

Medical Imaging Equipment Testing and Certification to Medical Device Standard IEC 60601

Medical imaging equipment is used to create visual representations of the interior of a body for clinical analysis, diagnosis, and treatment planning. These tools allow healthcare professionals to non-invasively examine organs, tissues, and other structures, enabling them to detect, monitor, or treat various medical conditions. Medical imaging plays a critical role in modern healthcare by improving diagnostic accuracy, reducing the need for exploratory surgeries, and enhancing patient outcomes.

Medical Imaging Equipment Testing refers to the evaluation, calibration, and maintenance of devices used in medical imaging to ensure their proper functioning, accuracy, and safety. These tests are essential to maintain the quality of diagnostic images, ensure patient and operator safety, and comply with regulatory standards.

Purpose of Testing:

Image Quality Assurance: Ensures the equipment produces clear and accurate images for reliable diagnosis.
Radiation Safety: Monitors radiation levels to minimize exposure to patients and staff.
Equipment Reliability: Identifies and addresses potential malfunctions before they affect clinical operations.
Regulatory Compliance: Meets the standards set by organizations such as the FDA, IEC, or local health authorities.

Common Types of Imaging Equipment Tested:

X-Ray Machines
CT Scanners
MRI Machines
Ultrasound Devices
Mammography Equipment
Nuclear Medicine Systems (e.g., PET, SPECT)

ENERGY STAR® Requirements for Medical Imaging Equipment | Fact Sheet

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ENERGY STAR® Requirements for Medical Imaging Equipment fact sheet

As the first accredited testing lab to certify a Magnetic Resonance Imaging (MRI) device to safety standards in the 1980s, Intertek maintains a level of expertise that far exceeds our competitors. To ensure your medical imaging equipment meets all applicable safety requirements per the ‘particular’ standards of 60601, rely on our electrical testing capabilities. We have decades of experience partnering with leading equipment manufacturers to evaluate navigation systems, MRI scanners, CT scanners, and X-ray equipment.

Medical Imaging Equipment	Particular Standards
Dental Extra-Oral X-Ray Equipment	IEC 60601-2-63: 2012
Dental Intra-Oral X-Ray Equipment	IEC 60601-2-65: 2012
Magnetic Resonance Equipment for Medical Diagnosis	IEC 60601-2-33: 2010
Mammographic X-ray Equipment and Stereotactic Devices	IEC 60601-2-45: 2011
Radiation Protection in Diagnostic X-ray Equipment	IEC 60601-1-2: 2007
Therapeutic X-ray Equipment (Operating Range 10 kV to 1 MV)	IEC 60601-2-8: 2010
Ultrasonic Physiotherapy Equipment	IEC 60601-2-5: 2009
X-ray Based Image Guided Radiotherapy Equipment	IEC 60601-2-68
X-ray Equipment for Computed Tomography	IEC 60601-2-44: 2009 COR 1: 2010
X-ray Equipment for Interventional Procedures	IEC 60601-2-43: 2010
X-ray Equipment for Radiography and Radioscopy	IEC 60601-2-54: 2009 COR 1: 2010
X-ray Tube Assemblies for Medical Diagnosis	IEC 60601-2-28: 2010