Tuesday, January 12, 2021

IEC 60601-1-2 Edition 4.1

September 2020, the EMC Standard for medical devices, IEC 60601-1-2 edition 4.1, has been published. Added to the FDA recognized consensus standards on December 21, 2020 with partial recognition. 

The FDA has designated a 3 year transition period, after which the previous version will not be accepted- REC#19-8 (IEC 60601-1-2:ed4.0 + ANSI AAMI IEC 60601-1-2:2014).

New testing requirements include 

  • Testing at minimum and maximum input voltage levels for conducted emissions and voltage dips and short interruptions
  • Power frequency magnetic field at either 50 or 60 Hz so long as the frequency is the same as that used to power the equipment
  • A new technical reference standard has been added IEC 61000-4-39:2017 
  • Magnetic field immunity testing requirements from 9 kHz to 13.56 MHz 
Some of the normative references have been updated to reflect new versions of older base standards updating requirements for emissions and surge and voltage dips. Removal of ISO 7137:1995 procedures for airborne equipment.

The standard includes guidance on the determination of immunity levels and adjustments according to implemented mitigations and intended use. Identification of pass/fail and guidance on risk management for basic safety and essential performance related to electromagnetic compatibility. 

FDA FR Recognition Number 19-36

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