# 132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-04-17
- Length: 31m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/132---IEC-60601--A-Life-Without-Standards--Evolution-of-Standards--Standards-Development--and-Emerging-Technologies-with-Leo-Eisner-e2ifssd

## Summary

Leo Eisner, founder of Eisner Safety Consultants, discusses the evolution and maintenance of medical device standards like IEC 60601, ISO 13485, and ISO 14971. He explains the distinction between IEC (electrical) and ISO (general/quality) standards, the challenges of auditing, and the bias in standards development voting. Eisner highlights the chaos of having no standards versus the handcuffs of having too many, noting the difficulty in pruning obsolete standards and the rise of new technologies like AI and cybersecurity in standards.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=0) Introduction: Leo Eisner and Eisner Safety Consultants
- [1:13](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=73) The Hypothetical Chaos of a Life Without Standards
- [3:08](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=188) The Explosion of Standards and Emerging Technologies
- [6:16](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=376) History of IEC 60601 and Naming Conventions
- [9:30](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=570) IEC vs. ISO: Electrical vs. General Quality Standards
- [12:53](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=773) The Auditing Experience and Qualification Process
- [19:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=1175) The Failed Recon Database Project
- [22:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=1361) Voting Bias and Pruning Standards
- [27:49](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm#t=1669) Assistive Robotics and Standard Types

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- Eisner Safety Consultants (company)
- IEC 60601 (other)
- ISO 13485 (other)
- ISO 14971 (other)
- IEC 62366 (other)
- UL (other)
- ASTM (other)
- NSAI (company)
- Pre-Safe (company)
- DMV (other)
- Nemco (company)
- Storts Imaging (company)
- EUMDR (other)
- Mestrich Treaty (other)

## Related episodes from other shows

- [#383: What Standards Apply to My Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-19-383-what-standards-apply-to-my-device) (Global Medical Device Podcast)
- [#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond](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) (Global Medical Device Podcast)
- [#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-10-401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [How to Leverage IEC 62304 to Improve SaMD Development Processes](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes) (Global Medical Device Podcast)

## Citing this page

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