How to Design for Compliance with IEC 60601

Episode Thumbnail
00:00
00:00
1x
  • 0.5
  • 1
  • 1.25
  • 1.5
  • 1.75
  • 2
This is a podcast episode titled, How to Design for Compliance with IEC 60601. The summary for this episode is: Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards? Claus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601. After all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them. IEC 60601 documentation is a lot to digest, which is a major challenge. But that does not mean you should neglect those standards. Applying the standards and making changes early on adds value and saves your company a lot of money. Some of the Highlights of the show include: -Road to Compliance: Design specific technical requirements during the early phases of product development, and perform design reviews and pre-testing. -How to integrate design input requirements from a risk-management perspective. -Why IEC 60601 standards are difficult for most people to navigate. IEC 60601 has 8 specific things you have to address in your risk-management process, but they don’t fit into or make sense in a typical risk analysis table. -The reason why the FMEA tool is not a useful tool regarding electrical safety: It is a single-fault failure, which is not sufficient. -Understand who will be using a product and in what kind of environments because that shapes what you need to do regarding electrical safety. -If you don’t follow standards, you face expensive and time-consuming redesign or you have to defend the effectiveness of your risk analysis. -The days of “I Promise” statements for electrical safety are gone, and they make for delays and redesign challenges.

DESCRIPTION

Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards? Claus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601. After all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them. IEC 60601 documentation is a lot to digest, which is a major challenge. But that does not mean you should neglect those standards. Applying the standards and making changes early on adds value and saves your company a lot of money. Some of the Highlights of the show include: -Road to Compliance: Design specific technical requirements during the early phases of product development, and perform design reviews and pre-testing. -How to integrate design input requirements from a risk-management perspective. -Why IEC 60601 standards are difficult for most people to navigate. IEC 60601 has 8 specific things you have to address in your risk-management process, but they don’t fit into or make sense in a typical risk analysis table. -The reason why the FMEA tool is not a useful tool regarding electrical safety: It is a single-fault failure, which is not sufficient. -Understand who will be using a product and in what kind of environments because that shapes what you need to do regarding electrical safety. -If you don’t follow standards, you face expensive and time-consuming redesign or you have to defend the effectiveness of your risk analysis. -The days of “I Promise” statements for electrical safety are gone, and they make for delays and redesign challenges.