Preface: According to relevant research, since 2010, the number of medical device reporting incidents related to equipment compatibility with electromagnetic fields has increased by more than 10 times. Among them, the growth rates of "wireless communication" issues and "electromagnetic compatibility" issues are the highest. Therefore, the FDA recommends taking stricter pre-market measures for equipment to ensure that the equipment has immunity.
Next, let's take a look at what "strict" measures have been implemented in the 2025 version of the standard compared to the previous one.
1. Standard application scope
The 2025 version of the standard is applicable to all in vitro diagnostic medical electrical equipment (IVD MEE), including:
· Blood analyzer
· Biochemical analyzer
· Immuno analyzer
· Nucleic acid amplification analyzer (PCR instrument)
· Blood glucose meter
· Urine analyzer, etc.
2. Raising the requirements for test levels
The 2025 version of the standard has updated the testing intensity and requirements for test items of EMS to meet the needs of the new technological environment:
Table 101- Equipment Requirements for PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT for EMS
Table 102 - Requirements for Equipment in the HOME HEAL THCARE ENVIRONMENT for EMS
Furthermore, taking into account the usage of radio communication devices in the family medical environment, the requirement in Table 103 has been increased:
If the equipment contains sensitive components or circuits, and the isolation distance between them and the magnetic field source is less than 0.15m, and this risk factor is also unacceptable, then according to the standard method of IEC 61000-4-39, these sensitive parts need to undergo close-range magnetic field immunity testing. See Table 104
The new standard has imposed stricter requirements on the performance criteria of IVD MEE:
The performance standards in Tables 101 to 104 have eliminated the grade determination methods of A, B, C, and D, and instead adopted the Pass/Fail determination method. Manufacturers should, based on the applicable risk management, determine specific and detailed test Pass/Fail determination criteria for the basic safety and key performance of electromagnetic interference.
The 2025 version of the standard has strengthened the requirements for risk management:
The equipment manufacturers are required to establish a complete risk management process in accordance with the requirements of ISO 14971:2019.
Pay special attention to the risk identification and control in the field of electromagnetic compatibility.
The manufacturer is required to conduct a risk analysis to determine which functions are considered "basic performance" and which performance degradation would pose an unacceptable risk to patient safety, that is, "critical performance".
To enhance the traceability of tests, the 2025 version of the standard has strengthened the requirements for documentation:
Request a more detailed EMC test plan, including equipment configuration, test conditions, performance criteria, etc.
The test report should include more comprehensive information to ensure its reproducibility.
Enhanced the requirements for EMC related information in the user manual.
This is the main content of the 2025 version standard update. All IVD MEE manufacturers can implement the new requirements as soon as possible according to the updated version.
BTL Shanghai has completed the study of the standard IEC 61326-2-6:2025 and has obtained the testing capability. If you would like to know more or have any inquiries, please contact us!
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