October 6, 2020
We are welcoming the Fall season with our October 2020 edition where we will examine:
• Gearing up for Amendment 2 of IEC 60601-1 standard
• Importance of thermal imaging equipment and proper testing
• Part 2 on power supplies: What you need to know about working voltages
• Tips on simplifying your medical equipment testing
• Turning medical device reports into completed tests
Amendment 2 of IEC 60601-1
Explore the background and key changes associated with the Amendment 2 (A2) publication where the TC 62 (Technical Committee response for the 60601 series of standards) began consideration of the items for 60601-1 Amendment 2.
Thermography Equipment Testing
Take a closer look at some of the practical aspects of thermography systems, medical imaging technology and some of the concepts covered in IEC 80601-2-59 for medical electrical equipment.
Power Supply Corner – Part 2: Working Voltages
In the second installment in our four-part series on power supply testing and certification, UL experts will examine processes, components, and standards specifically designed for patient protection.
Are you ready for your testing and certification process?
As you develop new medical equipment, a couple of things can be done to make your testing and certification process easier. We discuss how to review the requirements and ensure they get integrated into the equipment and what can be done within the construction phase.
Webinar Recap: Emergency Use Authorization (EUA) for Ventilators
On September 9th Pamela Gwynn (Principle Engineer) and Ben Dahlen (Engineering Manager) led a webinar concerning gaps between Emergency Use Authorizations (EUA) and full compliance with published standards in order to assist the device manufacturers in maintaining products on the market after the current pandemic is over.
Steps to Medical Product Test Completion
After completion of product evaluations, there are a large number of reports that document the product under evaluation, what standards were used, and test data gathered. Learn how to understand and use those reports to complete the testing process.
Recorded Webinar: Surgical Robots: Robotic Technology in Medical Standards – key aspects of IEC 80610-2-77 and IEC 80601-2-78 evaluations
The UL webinar focuses on key aspects of safety evaluations according to two standards, IEC 80601-2-77:2019 Medical Electrical Equipment - Part 2-77: Particular Requirements for the Basic Safety and Essential Performance of Robotically Assisted Surgical Equipment and IEC 80601-2-78:2019 Medical Electrical Equipment - Part 2-78: Particular Requirements for Basic Safety and Essential Performance of Medical Robots for Rehabilitation, Assessment, Compensation or Alleviation related to robotic technology in medicine. The presentation covers the origin of selected requirements as well as identified scope limitations. This information should help manufacturers designing medical robots covered by the standards with the implementation of the requirements into their design process.