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IEC 61010

How to ID Applicable Standards – Combinate Podcast

Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,

in a conversation with Subhi Saadeh of Combinate Podcast

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148

leoeisner August 7, 2024August 7, 2024 10993, 13485, 14708, 14971, 15223-1, 20417, 60601 Series, 60601-1, 60601-1, 4th edition, 61010, 62304, 62366, 62366-1, Active Implants, Architecture Specification, Aug 2024, Combination Device, Combination Product, Design Specification, Device, Draft Guidance, EMC, Essential Performance, EU, EU Commission, FDA, Final Guidance, Guidance, Guidance Documents, Hamonised Standards, Harmonized Standards, IEC, IEC 60601-1, IEC 61010, IMDRF, Information provided by the manufacturer, Interpretation Sheet 1, ISH1, ISO 10993, ISO 13485, ISO 14708, ISO 15223-1, ISO 20417, IVD, Labeling, Law, Marking, MDD, MDR, Medical Device, Medical Device Regulation, MHRA, Notified Bodies, PEMS, Podcast, Quality Assurance, Recognized Consensus Standards, Regulation, Regulatory Affairs, Risk Management, SaMD, Software, Standards, Standards Development, State of the Art, US, Usability, Usability Engineering Process, User Interfaces Read more

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Categories – Hot Topics

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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