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Safety Testing for Incubators

Gain an overview of the updated requirements for the basic safety and essential performance of infant incubators.

Infant incubator at intensive care

March 11, 2021

Innovative advancements in healthcare technology often come about through necessity. 

In July 2020, the International Electrotechnical Commission (IEC) published updates to standards that address specific requirements for infant incubators. The standards were the result of several years of work by joint committees of IEC and ISO individuals representing industry, test houses and regulators working to develop requirements to address the unique issues covered by these technologies.
For the IEC standard for incubators IEC 60601-2-19, Particular requirements for the basic safety and essential performance of infant incubators, the updates are:

  • Removal of dated reference to IEC 60601-1, so the latest edition of this standard can be used
  • The reference to IEC 60601-1-10, General requirements for basic safety and essential performance, is removed in various areas of the standard

For IEC 60601-2-20, Particular requirements for the basic safety and essential performance of infant transport incubators, the updates are:

  • Removal of dated reference to IEC 60601-1, so the latest edition of this standard can be used
  • The reference to IEC 60601-1-10 is removed in various areas of the standard
  • Clarification of which clauses of IEC 60601-1-12 are applicable

For IEC 60601-2-21, Particular requirements for the basic safety and essential performance of infant radiant warmers, the updates are:

  • The reference to IEC 60601-1-10 is removed in various areas of the standard.
  • Clarification about the Immunity levels according IEC 60601-1-2 to be used is introduced

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