IEC 60601-1, Fourth Edition: What to Expect

8 a.m. San Francisco | 11 a.m. Boston | 5 p.m. Berlin

The upcoming fourth edition of IEC 60601‑1 represents a significant evolution in the regulatory expectations for medical electrical equipment and medical electrical systems. This webinar will highlight major conceptual and structural changes anticipated for the standard, with a focus on how they may impact design, documentation and compliance activities for manufacturers and system integrators.

Key topics covered during the webinar

• Reorganization of general requirements by source of harm
• Integration of collateral standards into the base standard
• Removal of obsolete technologies
• Incorporation of evolving technologies in the programmable electrical medical system (PEMS) area, particularly cybersecurity and artificial intelligence
• Updated patient classifications and use environments
• Anticipated timeline for publication of the fourth edition

Why attend?

This webinar will provide engineering, quality and regulatory professionals with a foundational understanding of the anticipated transition to IEC 60601-1, fourth edition. Attendees will gain insight into the updated risk-based structure, the integration of emerging technologies, and the potential implications for system architecture, documentation strategies and certification planning.

Learning objectives

• Gain a clear understanding of the proposed changes.
• Explore evolving requirements and their potential impact.
• Identify practical considerations for future planning.

Register to attend the live session. If you are unable to join, an on-demand recording will be made available.

Speakers

Moderator: Maria Baker, Business Development Manager, Consumer, Medical and Information Technologies

Speaker: Pamela Gwynn, Principal Engineer, Consumer, Medical and Information Technologies