Product Testing and Certification

Changes and Impacts of the new EN 60601-1:2006 + A1:2013 + A2:2021(Amendment 2)

05. July 2021

In June 2021, Amendment 2 to EN 60601-1 (also referred to as Version 3.2 of IEC 60601-1) was published on the Cenelec web page.

The most significant changes are:

  • Updated terms and definitions to align with a new edition of ISO 14971:2019,
  • Some changes relating to safety signs, IP classification, batteries, power switches, and colours of indicator lights (including alarms),
  • Added clarifications to requirements for touch currents, means of protection (creepage distances/clearances), working voltage, defibrillation protection, and mains fuses (overcurrent) releases,
  • Added some clarifications to requirements for pressure vessels and other parts subject to pressure and to support systems,
  • Changes to construction requirements for fire enclosures,
  • Implementation of a new table for temperature limits of accessible parts likely, but not intended, to be touched during equipment operation.

SIQ will start testing according to the 3.2 edition in Q3 of 2021.

More information:
Janez Vidmar
Tel.: +386 1 4778 262

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