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.