Medical Imaging Equipment
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 - effective 10.1.13 | 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 - effective 6.1.13 | 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 - effective 4.1.13 | IEC 60601-2-28: 2010 |
Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.
Knowledge Center
- Medical Robots Fact Sheet
- UN 38.3 and the Transportation of Lithium Batteries: A Webinar Series
- Product Listing & Marking Strategies - white paper
- Updated FCC Approval Process - webinar recording
- Final Countdown to IEC 60601-1-2 4th Edition EMC - webinar recording
- 5 Steps to Medical Device Commercialization in the U.S. - webinar recording
- Cyber Security Assurance Safeguarding Patient Data - fact sheet
- Extractables and Leachables Studies - fact sheet
- Five Steps to Medical Device Commercialization in the United States - white paper
- Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage - white paper
- EMC 4th Edition RMF Requirements - webinar recording and slides
- Transitioning to IEC 60601-1 Edition 3.1 - white paper
- UN 38.3 and the Transportation of Lithium Batteries - webinar series
- How to Integrate Human Factors in the Development Process for FDA Compliance - webinar recording and slides