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

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.

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