“Technology has changed, we need to move with the technology change.”
In this Let’s Talk Risk! conversation, Leo Eisner shares a brief history of IEC 60601, the comprehensive global safety standard for active medical devices, and the work currently ongoing on the 4th edition. He is leading the group currently working on the user-interface aspects, which includes information provided by the manufacturer, usability, alarm system and also user interfaces aspects. There are a total of 12 working groups involved in various aspects of the standard, each focusing on a source of harm or hazardous situation.
Leo encourages risk practitioners in the industry to stay current with safety standards and consider taking an active role in the standards development process. This is a good way to be recognized as an industry expert and have an opportunity to shape the future direction of best practices.
Listen to this Let’s Talk Risk! conversation with Leo Eisner, the IEC 60601 Guy, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:25 Introduction
00:03:39 A brief overview and history of IEC 60601
00:06:30 A quick update on the work currently ongoing on the 4th edition
00:10:30 Reference documents for the 4th edition project
00:12:32 Why risk practitioners should get involved in standards development
00:14:25 Audience Q&A and open discussion
00:32:30 Closing comments and key takeaways
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Suggested links:
IEC: Architectural specification for safety standards of medical electrical equipment, medical electrical systems, and software used in healthcare, v 3.0.
IEC: Design specification for the 4th edition of IEC 60601-1
About Leonard (Leo) Eisner
Leonard Eisner the “60601 Guy” is the Founder and Principal compliance/regulatory consultant at Eisner Safety Consultants. He has worked at 3 notified bodies and in the medical device industry for over 30 years. His career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417 and other Working Group (WG), Maintenance Teams, and committees. He is an expert member of the development teams on IEC 60601-1, edition 3.2, and currently leading one of the WGs, an expert member of an another WG, and on the editing team (AG50) involved in the 4th edition of the standard.
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 69: A quick update on the 4th edition of IEC 60601