Medical Diagnostic Imaging Equipment
International testing and certification services
Overview

Stay ahead of an ever-evolving regulatory environment with CSA Group's proven line of services
CSA Group offers international medical imaging equipment testing and certification services, including IECEE (CB Scheme) testing according to the IEC 60601 series of medical standards, and FDA ASCA Program testing services. Our extensive range of accreditations and recognitions and full-service facilities make us a trusted resource and one-stop solution for many leading medical electrical and medical imaging equipment manufacturers across the globe.
Navigate regulatory standards with confidence
CSA Group provides testing, inspection, and certification services for a range of medical imaging equipment and systems, including:
- Diagnostic imaging equipment using an ultrasonic application
- Computed Tomography (CT) scanners
- Dental X-rays
- Digital Subtraction Angiography (DSA)
- Mammography units
- Magnetic Resonance Imaging (MRI) units
- Positron Emission Tomography (PET)-CT
- Radiation protection in diagnostic X-ray
- Radiography units
- Software evaluation
- X-ray equipment
- X-ray generators
- X-ray detectors
- X-ray tube assemblies
- X-ray equipment for radiography and radioscopy
Ensure that your medical imaging equipment is certified to the latest version of the International Electrotechnical Commission (IEC) 60601 series of standards relevant to your product. Download the fact sheet for information on the specific, applicable standards.
Global market requirements
No matter where your facilities are located in the world, our experts can develop a testing plan and certification program that meets your needs and the requirements of your target market.
Medical Diagnostic Imaging Equipment Testing and Certification Fact Sheet

Due to their design, medical imaging equipment and systems can contain unique safety and performance issues. Our team has the technical medical expertise to understand the requirements for existing, new, and emerging medical technologies.
Medical Diagnostic Imaging Equipment Testing and Certification
Shop Standards

Access North American and global markets by meeting the right standards for your medical electrical equipment and systems.
Services

Get your medical electrical equipment and systems tested, inspected, and certified for safety, cybersecurity, and global market access
Testing
Transform your innovations into quality products that meet critical requirements with our expert testing services.
Certifications
Launch new products, and boost customer confidence in North America and beyond with our global certification solutions.
Marks & Labels
Get the marks you need for local and global North American market access and enter your target market with confidence.
Value-Added Services
Save time and gain efficiencies with access to our customer portal, online product listings, and more.
Contact an
Expert

We’re always here to help. Let’s talk.
We’re here to answer your questions and help you get started right away. Call or send us a message anytime.