Hardware Podcasts

#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

Global Medical Device Podcast · 12 Dec 2024 · 42m · Episode 395

What this episode covers

Leo Eisner, founder of Eisner Safety Consultants and a key contributor to the IEC 60601 fourth edition, explains the structural and technical updates coming to the standard, including the consolidation of collateral standards and new requirements for wireless coexistence. He details the timeline for the 2029-2030 release, the modular hazard-based approach, and the importance of proactive test planning for medical device manufacturers. The discussion covers specific working groups, such as those handling user interfaces and physical environmental hazards, and how companies can engage with the standards development process through national committees and the Online Standards Development (OSD) tool.

Most relevant to

established companies

Topics

Mentioned

Also
IEC 60601, Greenlight Guru, BSI, FDA, ISO 15223, ISO 2417, IEC 62304, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11, IEC 60601-1-12, ISO 13485, ISO 14971, ISO 20417, IEC SC62A, Online Standards Development Tool

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