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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-12-12
- Length: 42m
- Episode: 395
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-12-12-395-iec-60601-updates-what-medtech-professionals-need-to-know-for-2025-and-beyon
- Listen: https://podcast.greenlight.guru/episode/395-updates-to-iec-60601

## Summary

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.

## Outline

1. Introduction: Leo Eisner and Eisner Safety Consultants
2. IEC 60601 Fourth Edition Structure and Timeline
3. Key Technical Changes: Wireless Coexistence and Collateral Standards
4. Working Groups and Categorization Updates
5. Engaging with Standards Development and OSD Tool
6. Proactive Test Planning and Regulatory Benefits

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Wireless & RF](https://hardwarepodcasts.com/topic/wireless-and-rf)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

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

## Related episodes from other shows

- [132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm) (Let's Combinate)
- [148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti) (Let's Combinate)
- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo) (Let's Combinate)
- [The Measurement Blues with Martin Rowe](https://hardwarepodcasts.com/podcast/the-amp-hour/2026-02-03-the-measurement-blues-with-martin-rowe) (The Amp Hour)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-12-12-395-iec-60601-updates-what-medtech-professionals-need-to-know-for-2025-and-beyon. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.