Medical equipment
EMC compliance for the RCM, CE, FCC and IC
Commonly used standards for EMC Testing Medical Equipment and similar equipment
Products include medical equipment, in vitro, blood analyser, hospital equipment, patient coupled equipment, ultra-sound, particle analyser, and many more.
Note: Any product with a radio transmitter/receiver will also require additional wireless/radio performance testing for information on radio testing click here.
RCM – Australia & New Zealand EMC compliance
Emissions testing (not all the listed standards may be required or listed)
IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
EN 61326-1 – Electrical equipment for measurement, control and laboratory use
Immunity testing
IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
CE – Europe EMC compliance
Emissions testing (not all the listed standards may be required or listed)
IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
EN 61326-1 – Electrical equipment for measurement, control and laboratory use
EN 61326-2-6 – Electrical equipment for measurement, control and laboratory use – Particular requirements – In vitro diagnostic (IVD) medical equipment
EN 61000.3.2 – Electromagnetic compatibility (EMC) – Limits for harmonic current emissions (AC mains only, Equipment input current less than or equal to 16 A per phase)
EN 61000.3.3 – Electromagnetic compatibility (EMC) – Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems (AC mains only, Equipment input current less than or equal to 16 A per phase)
EN 61000-3-11 Electromagnetic compatibility (EMC) – Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems – Equipment with rated current <= 75A and subject to conditional connection
EN 61000-3-12 Electromagnetic compatibility (EMC) – Limits – Limitation for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16A and <= 75A per phase.
Immunity testing (not all the listed standards may be required or listed)
IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
EN 61326-1 – Electrical equipment for measurement, control and laboratory use
EN 61326-2-6 – Electrical equipment for measurement, control and laboratory use – Particular requirements – In vitro diagnostic (IVD) medical equipment
FCC – North America EMC compliance
Emissions testing
CFR Title 47, SubChapter A, FCC Part 15, Subpart B – Unintentional radiators
CFR Title 47, SubChapter A, FCC Part 18
Immunity testing
The Food and Drug Administration (FDA) announced the introduction of immunity testing
IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
EN 61326-1 – Electrical equipment for measurement, control and laboratory use
EN 61326-2-6 – Electrical equipment for measurement, control and laboratory use – Particular requirements – In vitro diagnostic (IVD) medical equipment
ISED (previously IC) – Canada EMC compliance
Emissions testing
Typically a valid FCC test report with the relevant cross-references are deemed to be sufficient
Immunity testing
None
Please contact us for further details and what EMC testing services we can offer regarding EMC Testing Medical Equipment and similar equipment.