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.

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