Enhancing Safety Standards in Medical Electrical Equipment: Insights from IEC 60601 Series

Exploring the future of the IEC 60601 series at the Moscow event, Maurizio Andreano discusses safety standards, leadership structures, and value propositions. The presentation outlines key aspects like IEC TC 62, Amendment 2, Edition 4 updates, and more, emphasizing the importance of compliance, efficiency, and global market access in the medical device industry.

• Safety Standards
• Medical Devices
• IEC 60601
• Compliance
• Global Market

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1. THE FUTURE OF THE IEC 60601 SERIES Monday 18thMarch 2019, Moscow (Russia) Maurizio Andreano SWG Member; Vice-Chair DITTA Standardization WG Unrestricted

2. PRESENTATION OUTLINE 1. Overview IEC TC 62 Safety Standards, Structure and Leadership 2. IEC TC 62 Value Proposition 3. Amendment 2 to Third Edition of IEC 60601-1 4. Edition 4 of IEC 60601-1 AND related updates 5. Take Aways

3. IEC TC 62 SAFETY STANDARDS IEC 60601 SERIES & OTHERS Medical Electrical Equipment Part 2:Particular requirements for basic safety IEC 60601-2-X Particular Standards and essential performance e.g. Ultrasonic, defibrillator, X-ray machine, etc. Part 1-2: Electromagnetic Compatibility Part 1-3: Radiation Protection Part 1-6: Usability Part 1-8: Alarms Part 1-9: Environmentally Conscious Design Part 1-10: Physiological Closed-Loop Controllers Part 1-11: Home Healthcare Environment Part 1-12: Emergency Service Environment HARDWARE IEC 60601-1-X Collateral Standards IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance SOFTWARE ISO 14971 Medical devices Application of risk management to medical devices IEC 62304 Medical device software - Software life cycle processes IEC 82304-1 Health Software - Part 1: General requirements for product safety

4. IEC TC 62 STRUCTURE AND LEADERSHIP TC 62 Electrical equipment in medical practice Chair Michael Appel, US Sec DE Norbert Bischof Asst Sec Ms Annette Hagen 3 Advisory and Ad- hoc Groups 25 Working Groups and Maintenance Teams SC 62A Common aspects of electrical equipment used in medical practice Chair Richard Scott, UK Vice Chair Brodie Pedersen, US Sec US, Ms Hae Choe Asst Sec Charles Sidebottom 17 Working Groups and Maintenance Teams SC 62B Diagnostic imaging equipment Chair Yan Kang, CN Sec DE Norbert Bischof Asst Sec Ms Annette Hagen 4 Working Groups and Maintenance Teams SC 62C Radiotherapy, nuclear medicine and radiation dosimetry Chair Alan Cohen, US Sec DE Norbert Bischof Asst Sec Ms Annette Hagen 32 Working Groups and Maintenance Teams SC 62D Electromedical equipment Chair Klaus Neuder, DE Sec US Ms Hae Choe Vice Chair Jeffrey Eggleston, US

5. IEC TC 62 VALUE PROPOSITION For Industry: Comply with one set of safety standards to serve the world markets for medical devices. For Regulators: Make use of state-of-art requirements while saving resources when writing rules for medical devices. For Equipment User Organizations: Buy the best and most cost efficient medical devices from the world market.

6. AMENDMENT 2 TO THIRD EDITION OF IEC 60601-1 Shortlist of ~160 modifications for the General and the Collateral Standards. Goal of Edition 3.2 Address safety gaps, known problems for regulatory bodies, inconsistencies, technical errors and update of key standard references. No modification of the structure of existing General and Collateral Standards. As far as possible no changes creating a need to revise Particular Standards. Timeline Part 1 of the IEC 60601 series: IEC 60601-1 and IEC 60601-1-X CDVs expected Publication forecast Part 2 of the IEC 60601 series (no technical changes expected): IEC 60601-2-XX (~70 publications) First Publications Mid 2019 2020 2021

7. EDITION 4 OF IEC 60601-1 AND RELATED UPDATES First published in 1977, growing need to increase usability and future maintenance. New edition (26 sub goals identified) will focus on structure, maintainability, risk management, separation of process and product requirements, relationship to the Essential Principles of the IMDRF (coverage), etc. Architecture Team of TC 62 preparing a Technical Report as basis for revision (see 62/328/DC, open for comments until 2019-04-12). Publication of new General Standard not expected before 2024. Next Architecture Team meeting with Representatives from National Committees and Liaisons, May 7 to 9, in Luebeck, Germany.

8. TAKE AWAYS Compliance with IEC 60601 series has become an important part for the commercialization of safe medical electrical equipment around the world. Value of IEC 60601 series for basic safety and essential performance evident for all stakeholders. Release of Edition 3.2 addressing safety gaps while assuring necessary stability. Contribution to Edition 4 from all stakeholders desirable.

9. THANK YOU! ! www.globalditta.org Follow us on @DITTA_online