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.
The focus of this meeting was “level setting” all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification. The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week.
An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.
As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts. We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.
As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing. Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4th ed.
It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.
I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs begins….
Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.
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