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FDA updates its Recognized Consensus Standards list

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has added or updated nearly 100 voluntary consensus standards to its list of recognised standards for medical devices, available via its standards database search page.

The updated standards include a number from the IEC 60601 series, including references to consolidated versions of:

  • IEC 60601-1-2
  • IEC 60601-1-6
  • IEC 60601-1-8
  • IEC 60601-1-10
  • IEC 60601-1-11 and
  • IEC 60601-1-12

IEC 60601-1 edition 3.2 consolidated version has not yet been added to the list, but FDA comments that it is awaiting the update of ANSI AAMI ES 60601-1 before they add it and the IEC version to the database.

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