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EN/IEC 61326-2-6: 2020 RLV (Redline Version)

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EN/IEC 61326-2-6

EN/IEC 61326-2-6 specifies EMC requirements for in vitro diagnostic (IVD) medical equipment — a bridge between the measurement equipment IEC 61326 series and medical device EMC requirements. Part of the Compatible Electronics Learning Center.

What is EN/IEC 61326-2-6?

IEC 61326-2-6 is Part 2-6 of the IEC 61326 series, specifying particular EMC requirements for in vitro diagnostic (IVD) medical equipment. IVD equipment includes analyzers, reagent systems, and instruments used for examining specimens derived from the human body — blood analyzers, urinalysis instruments, glucose meters, molecular diagnostic platforms, and similar laboratory diagnostics.

IVD equipment occupies a unique regulatory position: it is medical equipment (subject to medical device regulations) but is fundamentally measurement and laboratory equipment in function. IEC 61326-2-6 applies when IVD equipment is outside the scope of IEC 60601-1-2 (the EMC standard for medical electrical equipment) — typically for non-electrically powered IVD devices or those where the IVD standard is specifically referenced in the regulatory pathway.

Compatible Electronics provides dedicated IEC 61326-2-6 IVD EMC testing services.

IVD Equipment Categories

  • Clinical chemistry analyzers (serum, plasma, urine)
  • Hematology analyzers (CBC, differential)
  • Immunoassay analyzers (ELISA, chemiluminescence)
  • Molecular diagnostics platforms (PCR, real-time PCR)
  • Point-of-care testing devices (blood glucose, cardiac markers)
  • Urinalysis instruments
  • Coagulation analyzers

Key EMC Requirements for IVD Equipment

1

Test Environment

IVD equipment is typically tested in a laboratory or clinical laboratory environment — classified as a commercial or light-industrial location in EMC terms. Immunity levels generally align with the IEC 61000-6-1 generic immunity standard for residential/commercial environments.

2

Performance Criteria for Diagnostic Equipment

Performance criteria for IVD equipment must account for the clinical significance of measurement accuracy. Allowable performance degradation during immunity testing is defined in terms that are meaningful for the specific measurement function — for example, acceptable deviation from the target analyte concentration reading.

3

Emissions

Emission requirements for IVD equipment follow the applicable limits from IEC 61326-1, typically Class B limits for equipment used in hospital or clinical laboratory settings that may be co-located with sensitive medical equipment.

Standard VersionLocations Accredited
IEC 61326-2-6, Ed. 1.0 (2005-12)Lake Forest/Silverado, Brea, Newbury Park

Related Resources

IEC 61326-2-6 IVD EMC Testing Services IEC 61326 Testing Services EN/IEC 61326-2-1 EN/IEC 61326-2-3 Medical Device EMC Testing IEC 60601-1-2 Medical EMC Testing ESD Immunity Testing FDA ASCA Accreditation ISO/IEC 17025 Accreditation Learning Center Home

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