Medical Robotics

Testing, inspection and certification services

Overview

Revolutionizing Healthcare with Medical Robotics

Standards play an active role in shaping the requirements for medical robotics safety and CSA Group has been at the heart of standards development for decades. With extensive experience working with the medical industry, CSA Group provides testing, inspection and certification services for compliance with applicable standards, so your organization can focus on solving unmet medical needs with new and innovative robotic technologies.

Testing and certification services include IECEE (CB Scheme), the FDA ASCA Pilot Program, and testing according to the IEC 60601, IEC/ISO 80601 series of medical standards.

Demonstrate compliance to standards relevant to your product

CSA Group provides testing, inspection, and certification services for a range of medical robots, helping you demonstrate compliance with standards relevant to your product.

  • Safety standards:
    • CSA/AAMI/EN/IEC 60601-1:ED3.1 and IEC 60601-1:ED 3.2 (general standards)
    • IEC 60601-1-10
    • IEC 60601-1-8 (Alarms)
    • IEC 80601-2-77 (RASE, RASS)
    • IEC 80601-2-78 (RACA)
  • Electromagnetic Compatibility (EMC) standards:
    • IEC 60601-1-2
  • Process standards:
    • IEC 60601-1-6 (Usability)
    • IEC 62366, IEC 62366-1 (Usability)
    • IEC 62304 (Software)
    • ISO 14971 (Risk management)
  • Dental standards:
    • 80601-2-60 (Dental surgical)
    • IEC 60601-2-63 and IEC 60601-2-65 (Medical electrical equipment)

If medical robots incorporate other types of equipment, additional standards may be applicable:

  • 60601-2-2 (High-frequency surgical equipment)
  • 60601-2-18 (Endoscopic equipment)
  • 60601-2-22 (Laser equipment)
  • 60601-1-11 (Robotics for home environment)

Global market requirements

No matter where your facilities are located in the world, our local 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.