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Dec 2024

IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,

leoeisner December 12, 2024December 12, 2024 10993, 13485, 14971, 15223-1, 20417, 60601 Series, 60601-1, 60601-1-10, 60601-1-11, 60601-1-12, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1, 4th edition, 62304, 62366, 62366-1, Alarm Systems, Architecture Specification, Coexistence, Dec 2024, Design Specification, Device, EMC, Essential Performance, FDA, Greenlight Guru, Guidance Documents, Hazards, IEC, IEC 60601-1, Information provided by the manufacturer, Ionizing radiation, ISO 10993, ISO 13485, ISO 15223-1, ISO 20417, Labeling, London, Marking, Mechanical, Medical Device, PEMS, Physiologic Closed-Loop Control, Podcast, Recognized Consensus Standards, Regulation, Regulatory Affairs, Risk Management, SaMD, Scotland, SiMD, Software, Standards, Standards Development, State of the Art, UK, US, Usability, Usability Engineering Process Read more

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510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC 60601-1 IEC60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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