Medical Imaging Equipment Testing and Certification to Medical Device Standard IEC 60601
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)
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 |
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*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.
