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Amendment 2 of IEC 60601-1

Stay ahead of upcoming IEC 60601-1 changes.

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October 2, 2020

The present and future of IEC 60601

Over the next few issues we will explore the background and key changes associated with the IEC 60601 Amendment 2 (A2) publication. In this issue we explore the background for the creation of A2 - in 2015 the TC 62 (Technical Committee responsible for the 60601 series of standards) began consideration of the items for 60601-1 Amendment 2. The items that were considered for the amendment, were those that achieved a 2/3 affirmative vote by the National Committees during the Technical Committee meeting held in Frankfurt Germany in October 2016.

Various maintenance teams and working groups within TC62 associated with the part 1 standard and related collaterals were assembled to address the agreed upon items. They worked to consider the items brought forward and proposed modification to the respective standards including the addition of IEC 62368-1 (Audio/video, information and communication technology equipment) into the part 1 standard.

Pathway to Standard amendment

The Final Draft International Standard (FDIS) was sent out to the national committees in April of 2020 with votes required by June, 2020 for IEC 60601-1 (part 1), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 60601-1-8 (Alarms), IEC 60601-1-9 (Environmental Conscious Designs), IEC 60601-1-10 (development of physiologic closed loop controllers), IEC 60601-1-11 (home healthcare), and IEC 60601-1-12 (equipment and systems intended for use in the emergency medical services environment).

The FDIS for the above standards received affirmative votes from the national committees and publication of the standards occurred in August of 2020.

Over the next few issues of this newsletter, we will highlight key changes related to A2. This includes:

  • Collateral standards
  • Reference standards (for example ISO 14971, IEC 62304 and IEC 62366-1)
  • Means of Patient Protection (MOPP) referencing IEC 62368-1 (separate article series)

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