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., focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.
Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.
Key Points:
- New Modular Approach:
- The updated standard adopts a modular approach (12 working groups focused on specific hazard areas).
- Simplifies updates by consolidating Collateral Standards into the General Standard.
- Aligns better with global regulations.
- IEC 60601-1 4th Edition:
- Focuses on addressing various hazards including:
- physical environment,
- electrical,
- thermal and fire,
- mechanical,
- user interface (usability, alarms, information supplied by the manufacturer & user interface aspects),
- materials,
- optical radiation, and
- electromagnetic exposure hazards.
- Focuses on addressing various hazards including:
- New Requirements:
- Introduces new international requirements for wireless coexistence and other cutting-edge technologies (e.g., gas pathways, user interface aspects).
- Consolidation of Standards:
- Collateral standards are being consolidated to improve consistency and reduce the update cycle time for the 60601 series.
- Timeline and Publication Dates:
- Expected timeline for the fourth edition is 2029-2030.
- Companies need to plan now, though the actual timeline may slip depending on various factors.
- Benefits of Proactive Planning:
- Proactive planning and test preparation are essential for regulatory success.
- Staying informed and embracing continuous learning in MedTech are key factors for success.
- Practical Advice for Compliance:
- Begin designing for new standards early, even before they are finalized. MedTech design cycles are long.
- Engage with industry groups and standards organizations.
- Use test planning to streamline development and meet regulatory expectations efficiently.
- Engaging in the Standards Development Process:
- Manufacturers are encouraged to engage in the standards development process and submit comments.
- This proactive approach can help shape the standards and ensure they are practical and achievable.
These updates aim to enhance safety and performance while keeping pace with technological advancements. Manufacturers need to stay informed and prepare for the impact these changes will have on their product lines and quality systems.
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Need Help?
Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety and EMC and can arrange other testing as well. Feel free to schedule a web meeting with Leo or contact us.