The State of Standardization Work for IEC 60601-1

More than 200 experts from around the world, including two from UL Solutions, recently convened for the International Electrotechnical Commission (IEC) fourth edition project kick-off meeting — marking an important milestone in the field of standardization in healthcare. The IEC Technical Committee 62/Subcommittee 62A (IEC TC 62/SC 62A) held this meeting at the Association for the Advancement of Medical Instrumentation (AAMI) headquarters in Arlington, Virginia, from April 29 through May 3, 2024.

The focus of this meeting was to reiterate the design specifications and basic directions of the fourth edition of IEC 60601-1 to the experts in attendance. During the meeting, leadership established the eight main goals:

• Sharpen the focus on basic safety and essential performance.
• Reconcile requirements into a single statement.
• Simplify the structure of the IEC 60601-1 series.
• Increase separation of type testing and process requirements.
• Clarify the scope of the IEC 60601-1 series.
• Establish a policy relating requirements of the IEC 60601-1 series to the IMDRF Essential Principles and Labelling Principles.
• Establish a policy for schedules release and stability dates.
• Establish training for the authors of documents developed by IEC/TC 62.

Under this framework, twelve working groups:

• Established consensus and early work tasks in their respective fields, and
• Actively discussed the:
  • integration of related collateral standards,
  • separation of type testing and process requirements, and
  • addition of new content and requirements.

Work also began on reconciling requirements into a single statement in order to increase understanding and readability of requirements.

The IEC TC62 Working Group 4 introduced and emphasized the importance of unified terminology, especially the new terminology that will be involved in the drafting of the fourth edition of the standard, which needs to be discussed in advance.

Each working group has been tasked with outputting portions of their sections before the fall meeting to promote further discussion and coordination between working groups.

In attendance at this meeting were Pamela Gwynn and Winn Henderson of UL Solutions. Gwynn is global principal engineer with our Consumer, Medical & Information Technologies group, and she is the co-convenor of Working Group 43. Henderson, global principal engineer, Optical on the Consumer, Medical & Information Technologies group, is a co-convenor of Working Group 45. Seven other experts from UL Solutions attended, gathering from the United States, China, Germany, Denmark and Great Britain to participate in several working group meetings.

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