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 Pilot 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.

Shop Standards

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

CSA group has a wide range of global experience in developing standards for medical electrical equipment and systems. The standards we test against include IEC 60601 and IEC 61010.

Services

Get your medical electrical equipment and systems tested, inspected, and certified for safety, cybersecurity, and global market access

Testing

Testing

Transform your innovations into quality products that meet critical requirements with our expert testing services.

Certifications

Certifications

Launch new products, and boost customer confidence in North America and beyond with our global certification solutions.

Marks & Labels

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

Value-Added Services

Save time and gain efficiencies with access to our customer portal, online product listings, and more.