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IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

leoeisner May 6, 2024May 6, 2024 14971, 15223-1, 20417, 60601 Series, 60601-1, 60601-1-10, 60601-1-11, 60601-1-12, 60601-1-6, 60601-1-8, 60601-1, 4th edition, 62304, 62366, 62366-1, AAMI, Alarm Systems, Architecture Specification, Coexistence, Cybersecurity, Design Specification, Device, Draft Guidance, EMC, Essential Performance, EU, FDA, Guidance Documents, Hazards, IEC, IEC 60601-1, IMDRF, Information provided by the manufacturer, Interpretation Sheet 1, Ionizing radiation, ISH1, ISO, ISO 15223-1, ISO 20417, Labeling, Machine Learning, Marking, May 2024, MDD, MDR, Mechanical, Medical Device, Medical Device Regulation, MHRA, Notified Bodies, PEMS, Physiologic Closed-Loop Control, Regulation, Regulatory Affairs, Risk Management, SaMD, SiMD, Single Fault Condition, Software, Standards, Standards Development, State of the Art, UDI, Usability, Usability Engineering Process, User Interfaces Read more

Standards: Explosion and Challenges Maintaining/Updating

My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.

leoeisner April 18, 2024April 18, 2024 13485, 14971, 15223-1, 20417, 60601 Series, 60601-1, 60601-1, 4th edition, 62304, 62366, 62366-1, Active Implants, AI, Apr 2024, Auditing, Combination Device, Combination Product, Cybersecurity, Device, Essential Performance, EU, FDA, Guidance Documents, Harmonized Standards, IEC, IEC 60601-1, ISO 13485, ISO 15223-1, ISO 20417, IVD, Machine Learning, MDD, MDR, Medical Device, Medical Device Regulation, Notified Bodies, Quality Assurance, Recognized Consensus Standards, Regulation, Regulatory Affairs, Risk Management, SaMD, Software, Standards, Standards Development, US 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 IEC60601-1 IEC 60601-1 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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