IEC 60601-1-2 Medical EMC Tests
Which EMC tests are applied according to IEC 60601-1-2 or EN 60601-1-2? How many EMC tests are mentioned in the standard? IEC 60601-1-2 or EN 60601-1-2 lists applicable EMC tests for medical equipments or systems. On this page we are summarizing medical EMC tests. We are offering both medical EMC testing services and EMC test equipments compliant with the standard. Contact us and certify your medical devices.
IEC 60601-1-2 is listing EMC tests that has to be applied for medical devices. On this page, you will find all EMC tests mentioned on the standard. Recent version of the standard is IEC 60601-1-2:2014/A1:2020. You can reach all previous versions by visiting IEC’s web page.
IEC 60601-1-2 list the EMC requirements of medical devices. There are different type of EMC tests which are applicable for medical devices. These tests are may not be applied to every medical device since the standard defines some exemptions. To define exact test plan for your product, you have to check the standard or send us your product’s features. We can define which tests are applicable to your medical device.
In general EMC tests according to IEC 60601-1-2 are categorized into two categories: emissions and immunity.
There are four type of EMC tests which are categorized as emissions tests. During emissions tests, measuring instrument is used to measure unwanted signals emitted from the medical device or system tested. There are certain emission limits for each test.
|Test Name||Reference Standard(s)|
|Conducted RF Emissions||IEC 61000-4-2|
|Radiated RF Emissions||IEC 61000-4-4|
|Harmonic Distortion||IEC 61000-4-5|
|Voltage Fluctuations and Flicker||IEC 61000-4-6|
Conducted RF Emissions and Radiated RF Emissions are also named as Conducted Emissions and Radiated Emissions. Harmonic Distortion is also known as Harmonics.
There are eight types of EMC tests which are categorized as immunity tests. During immunity tests, medical device or system is subjected to an interfering signal. Tested medical device or system is monitored during immunity tests whether interfering signal affects allowed performance level of the product.
|Test Name||Reference Standard(s)|
|Electrostatic Discharge (ESD)||IEC 61000-4-2|
|Radiated RF EM Fields||IEC 61000-4-3|
|Proximity Fields from RF Wireless Communications Equipment||IEC 61000-4-3|
|Electrical Fast Transients/Bursts||IEC 61000-4-4|
|Conducted Disturbance induced by RF Fields||IEC 61000-4-6|
|Rated Power Frequency Magnetic Fields||IEC 61000-4-8|
|Voltage Dips and Interruptions||IEC 61000-4-11|
| Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz
Immunity test requirements for ME Equipment and ME Systems are on a port-by-port basis. As given on IEC 60601-1-2:2014 (EN 60601-1-2:2015) there are five type of ports: Enclosure, AC Power, DC Power, Patient Coupling and SIP/SOP.
Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz tests are added with recent version which is IEC 60601-1-2:2014+A1:2020. For these magnetic field immunity tests, reference test standard is IEC 61000-4-39.
Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz shall be evaluated according to steps a) through d) below. The result of the evaluation for each applicable step shall be documented in the test report.
a) ME EQUIPMENT and ME SYSTEMS that do not contain magnetically sensitive components or circuitry within the ENCLOSURE or as part of an attached ACCESSORY need not be evaluated further for IMMUNITY to proximity magnetic fields in the frequency range 9kHz to 13.56MHz; otherwise,
b) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry where a seperation distance of those components or circuitry of at least 0.15m from the field sources specified in Table 11 is ensured by ENCLOSURE or by the physical design of an attached ACCESSORY during INTENDED USE need not be evaulated further for IMMUNITY to proximity magnetic fields in the frequency range 9kHz to 13.56MHz; otherwise,
c) Perform a RISK ANALYSIS regarding exposure of the ME EQUIPMENT or ME SYSTEM to the frequencies, field strengths, and modulations specified in Table 11 at seperation distances less than 0.15m. If the RISK of exposure, during INTENDED USE, to the frequencies, field strengths, and modulations specified in Table 11 is acceptable, then the tests of Table 11 need not to be performed; otherwise,
d) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry not meeting the seperation distance criteria in b) or the RISK acceptibility criteria in c) shall be tested for IMMUNITY to magnetic fields as specified in Table 11 usinig the test methods specified in IEC 61000-4-39. The magnetic field shall be applied only those surfaces of the ENCLOSURE or attached ACCESSORIES that are accessible during intended use. The test windows to be used with IEC 61000-4-39 may be selected to illuminate only the are of the magnetically sensitive components or circuitry. The location of application of the magnetic field should be specified in the test plan and shall be documented in the test report.
Table 11- Test specification for Enclosure Port Immunity to proximity magnetic fields
|Test frequency||Modulation||Immunity Test Level (A/m)|
* This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the home healthcare environment. ** The carrier shall be modulated using a 50% duty cycle square wave signal. *** r.m.s., before modulation is applied.
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