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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 07/28/2025 
FR Recognition Number 19-57
Standard(Included in ASCA)
IEC  61326-2-6 Edition 4.0 2025-06
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.

BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.

NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of IEC 61326-2-6 Edition 3.0 2020-10 [Rec# 19-43] will be superseded by recognition of IEC 61326-2-6 Edition 4.0 2025-06 [Rec# 19-57]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-43] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 19-43] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Electromagnetic Compatibility (EMC) of Medical Devices, issued June 2022.

Mosleh, Susanna et al., A Metrology-Driven Approach to Distilling Live Wireless Signals Into Immunity Test Signals, Volume 13, IEEE Access, Feb 2025.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
 Kausik Datta
  CDRH/OPEQ/OHTVII/DMD/BAC1
  --
  kausik.datta@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Groups (STG)
General II (ES/EMC) (primary)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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