EN 60601 or IEC 60601 is the European harmonized standard to meet the Medical Device Directive. EN 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. While this standard is broadly considered all encompassing, it is important to note that in addition to EN 60601, there are dozens of additional standards that address unique features and characteristics of medical devices.
The testing completed under EN 60601 includes the following:
There are several clauses within EN 60601 that require increased attention. One of these clauses states, “the essential performance of equipment and systems shall be identified by a risk analysis. If the risk analysis is not performed, all functions of the equipment or system shall be considered essential performance for the purpose of immunity testing.” Essential performance is defined in the standard as “performance characteristics necessary to maintain the Residual Risk within acceptable limits”. Essential performance should be determined by a risk analysis. If a risk analysis is not completed, all functions of the medical device shall be considered essential.
It should be noted that EN 60601 places the burden of determining pass or fail on the device manufacturer, not the EMC test lab, since ultimately the medical device manufacturer determines which functions are essential performance.
EN 60601 presents unique challenges to medical device manufacturers.
|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 disturbancesCISPR 22, Information technology equipment – Radio disturbance characteristics – Limits and methods of measurement|
Included below are all of the sections of IEC 60601-1:
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