IEC 60601-1 4th Edition Seminar: An Overview and Q&A with Members of the Standards Team
4th edition has been in active development with committee drafting since April 2024, where are we at now in the development timeline and what changes are coming?
Join this live and virtual session to explore the impact of IEC 60601-1 4th edition and key requirements of the current draft fragments.
This technical webinar is designed to help engineers and regulatory professionals better understand how this developing standard is impacting device design requirements, new or changing test parameters, and overall compliance strategy.
What You'll Learn
- Fourth edition goals: Understand the core objectives.
- New terminology standards: Stay current with updated definitions.
- Overview of the different working groups
- Summaries of the latest committee draft fragments (12 total)
- Integrating new topics: Reliability, maintenance and repair, degree of autonomy, distributed essential performance, conformity evaluation planning, software: as a medical device & in a medical device, etc.
- A deeper dive into the developing requirements for physical environment hazards and mechanical hazards
- How to get you and/or your company involved in standard development
Who Should Attend?
This session is ideal for:
Medical device design engineers
Regulatory and compliance professionals
Product development teams
Quality and testing specialists
Anyone involved in 60601!
Special Panelists
Leonard (Leo) Eisner, P.E. “The IEC 60601 guy“
Principal Regulatory & Compliance Consultant
Eisner Safety Consultants
IEC SC 62A / WG 39 Convener - User Interface Aspects Hazards - IEC 60601-1, 4th ed.
IEC SC 62A / WG 37 Member – General Requirements - IEC 60601-1, 4th ed.
Leo Eisner is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants, which provides the medical device industry with product safety compliance & regulatory support. As 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.
- Provided expertise to 100’s of SMEs and Fortune 500 companies for successful medical device compliance projects
- Reviewed/generated 30+ product safety and labeling/marking sections of EU technical file/technical documentation (MDD/MDR) / DHF for active medical devices and active medical implantables
- Expert Member of development teams on IEC 60601-1, edition 3.2 (via IEC TC62/SC 62A/MT28 & MT30 & WG14 & IEC TC62A/Ad Hoc Group 62368-60601) and 4th edition of IEC 60601-1
Caitlin Brady
Medical Principal Engineer
TÜV Rheinland
IEC SC 62A / WG 38 Secretary - Physical Environment Hazards - IEC 60601-1, 4th ed
Caitlin Brady is a Medical Principal Engineer at TÜV Rheinland in Boxborough, MA and an expert in medical device compliance. For nearly 15 years, Caitlin has served as a trusted partner to clients ranging from startups to global enterprises, helping them navigate complex regulatory landscapes with precision and clarity. She specializes in testing to ensure Basic Safety and Essential Performance according to the IEC 60601 and ISO 80601 series of medical safety standards. Her expertise includes comprehensive evaluations of Risk Management, Usability, and multiple particular standards.
Cailtin is a key contributor to several developing standards, currently focusing on the IEC 60601-1 4th edition. She serves as Secretary of TC 62/SC 62A/WG 38 (Environmental Hazards) and is a member of the Editing Team for the 4th Edition (TC 62/SC 62A/AG 50).
Elizabeth (Liz) Casey
Medical Principal Engineer
TÜV Rheinland
IEC SC 62A / WG 43 Secretary - Mechanical Hazards - IEC 60601-1, 4th ed
Liz Casey is a Medical Principal Engineer at TÜV Rheinland in Boxborough, MA and an expert in medical device compliance. For nearly 15 years, Liz has served as a trusted partner to clients ranging from startups to global enterprises, helping them navigate complex regulatory landscapes with precision and clarity. She specializes in testing to ensure Basic Safety and Essential Performance according to the IEC 60601 and ISO 80601 series of medical safety standards. Her expertise includes comprehensive evaluations of Risk Management, Usability, and multiple particular standards.
Liz is a key contributor to several developing standards, currently focusing on the IEC 60601-1 4th edition. She serves as Secretary of TC 62/SC 62A/WG 43 (Mechanical Hazards) and is a member of the Editing Team for the 4th Edition (TC 62/SC 62A/AG 50).
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