Steps for Evaluation of Immunity to Proximity Magnetic Fields

What is Immunity to Proximity Magnetic Fields?

A new EMC test is added to latest version of medical EMC standard IEC 60601-1-2 (Edition 4.1). This test is named as immunity to proximity magnetic fields since extra magnetic and radiated immunity tests are required for new frequencies and with new test setup.

Which products are under the scope of this new test?

Immunity to proximity magnetic fields tests can be applied to all medical devices which are under the scope of IEC 60601-1-2:2014+A1:2020 (or EN 60601-1-2:2015+A1:2021).

Figure A.3 of the standard is a flowchart and you can make an evaluation whether a medical device under the scope of this new test. If mentioned exemptions of this evaluation fit with the product, immunity to proximity magnetic fields tests can be excluded.

Let’s check this evaluation steps:

1. Begin evaluation of immunity to proximity magnetic fields

2. Manufacturer chooses to perform tests regardless of exemptions (Make a decision at this step)

2.a. If your decision Yes: Specify and document locations of test in the test plan and test report. Perform testing in accordance with Table 11 of the standard. End evaluation of immunity to proximity magnetic fields at this step.

2.b. If you decision No: Answer this question:

Does the product contain magnetically sensitive components or circuitry?

2.b.i. If you say No again, document this decision in the test plan and test report. Testing is not required. End evaluation of immunity to proximity magnetic fields at this step.

2.b.ii. If you say Yes, answer this question:

Does the enclosure of the physical design of any attached accessories ensure a seperation distance of ≥0.15m between magnetically sensitive components or circuitry and the field sources specified in Table 11 during intended use?

If your answer is Yes, document this decision in the test plan and test report. Testing is not required. End evaluation of immunity to proximity magnetic fields at this step. 

If your answer is No, answer this question: Are the risks associated with exposure to the field sources specified in Table 11 at distances <0.15m acceptable? If your answer to this question is Yes, document in Risk Management File without testing and End evaluation of immunity to proximity magnetic fields at this step. If your answer to this question is No, specify and document locations of test in the test plan and test report. Perform testing in accordance with Table 11 of the standard. End evaluation of immunity to proximity magnetic fields at this step. 

Check the Figure A.3 of the IEC 60601-1-2 (EN 60601-1-2) and make your decision. 

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