EN 60601-1-2 EMC Testing of Medical Electronic Equipment
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Summary of EN 60601-1-2 EMC Compliance Testing
EN 60601-1-2 applies to the basic safety and performance of medical electrical equipment and medical electrical systems. EN 60601-1-2 is harmonized with the IEC 60601-1-2 test standard. EN 60601-1-2 EMC testing is recognized around the globe to ensure that Electromagnetic Compatibility failures do not create unnecessary risks to patients, medical professionals, and/or Medical Equipment/Systems.
Electronic medical devices must comply with the EN 60601-1-2 EMC test before the devices enter the market. The EN 60601-1-2 fourth edition is the most current edition of the EMC standard. However, many devices in services may need testing to previous editions like the EN 60601-1-2 third edition, second edition, or first edition.
The testing completed under EN 60601-1-2 includes the following:
- Electrostatic Discharge
- Radiated Immunity
- Fast Transient
- Conducted Immunity
- Power Frequency Magnetic Fields (voltage dips, interruptions, and variations)
Medical electronic equipment and medical electrical systems are tested in intended use and configuration that may most likely to result in unacceptable risk. The configurations of medical electrical equipment and systems include:
- Attachment of cables to all ports
- Attachment of all tubing and filling of all fluid containers
- Termination of the cables with the intended equipment, subsystem simulators, physiological simulators, or artificial hands
- Earthing on the enclosure port including connections to the terminal for the connection of a potential equalization conductor
- Use of cables and connectors that meet the specifications of the medical electrical equipment or medical electronic system manufacturers.
The electromagnetic emission requirements state that unless otherwise specified, medical electrical equipment and systems must comply with CISPR 11. During IEC 60601-1-2 emission testing, the equipment is tested in the modes that maximize emissions. The immunity test requirements are conducted on a port-by-port basis. This follows the convention of the 61000-6 series of generic EMC standards.
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For related standards, please follow the links below.
|IEC 60417:||Graphical symbols for use on equipment|
|IEC 60601-1:||2005 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance|
|IEC 60601-1-8:||2006 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems|
|IEC 61000-3-2, Electromagnetic compatibility (EMC) – Part 3-2||Limits – Limits for harmonic current emissions (equipment input current 16 A per phase)|
|IEC 61000-3-3, Electromagnetic compatibility (EMC) – Part 3-3:||Limits – Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current 16 A|
|IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2:||Testing and measurement techniques – Electrostatic discharge immunity test|
|IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3:||Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test|
|IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4:||Testing and measurement techniques – Electrical fast transient/burst immunity test|
|IEC 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5:||Testing and measurement techniques – Surge immunity test|
|IEC 61000-4-6:2003, Electromagnetic compatibility (EMC) – Part 4-6:||Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields|
|IEC 61000-4-8, Electromagnetic compatibility (EMC) – Part 4-8:||Testing and measurement techniques – Power frequency magnetic field immunity test|
|IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11:||Testing and measuring techniques – Voltage dips, short interruptions and voltage variations immunity tests|
|CISPR 11:||Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement|
|CISPR 14-1:||Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission|
|CISPR 15:||Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment|
|CISPR 16-1-2:||Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Ancillary equipment – Conducted disturbances CISPR 22, Information technology equipment – Radio disturbance characteristics – Limits and methods of measurement|