Hardware Podcasts

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

Let's Combinate · 17 Apr 2024 · 31m

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Eisner Safety Consultants, NSAI, Pre-Safe, Nemco, Storts Imaging
Also
IEC 60601, ISO 13485, ISO 14971, IEC 62366, UL, ASTM, DMV, EUMDR, Mestrich Treaty

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