AIM 7351731

The AIM 7351731 standard provides test methods and test levels for evaluating the electromagnetic immunity of (non-implantable) medical electrical equipment and systems when exposed to electromagnetic emissions from radio-frequency identification (RFID) readers. The standard focuses on the most common RFID technologies currently deployed in healthcare environments (LF, HF, UHF) and explicitly does not address other wireless technologies such as Wi-Fi and ultra-wideband (UWB). It is intended to complement and extend the baseline immunity requirements of standards such as IEC 60601‑1‑2, particularly in scenarios where medical electrical equipment may be exposed to RFID readers in close proximity.

The exact title of the standard is: Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers – An AIM Standard

Key Features and Highlights

• Specifies immunity exposure levels for RFID reader-emissions in LF, HF and UHF bands, both passive and active technologies.
• Includes both magnetic field (H-field) and electric field (E-field) test conditions, particularly relevant because some RFID standards (e.g., 134.2 kHz, 13.56 MHz) operate in low-frequency magnetic fields not addressed by many older immunity standards.
• Indicates applicability based on proximity: i.e., medical equipment that may be located near an RFID reader (for example within tens of centimetres) is more likely to require full compliance.
• Helps both device manufacturers (medical equipment) and facility engineers/administrators (RFID infrastructure) assess compatibility between medical equipment and RFID reader environments.

Typical Application and Test Conditions

For medical electrical equipment used in settings where RFID readers may be present, the standard aims to:

• Assess whether the equipment/system continues to function safely and as intended when exposed to RFID reader emissions.
• Apply test levels covering multiple RFID frequencies and modalities of operation.
• Address scenarios where a medical device may be in the proximity of an RFID reader (for example asset tracking wristbands, medication tagging, inventory carts) and thus be subject to the emissions from the reader.

Relationship to Other Standards

• The standard is recognised by the FDA as a consensus standard for medical devices.
• Table 11 of IEC 60601-1-2:2020 (Ed. 4.1) includes RFID immunity test conditions influenced by AIM 7351731, but AIM 7351731 remains more extensive (covering more frequencies/test levels) for devices which must address RFID immunity explicitly.
• Because Wi-Fi, UWB, and other wireless technologies are excluded from AIM 7351731, manufacturers will need to consider additional immunity standards/tests (or risk-based justification) if their device may be exposed to those sources.

Scope of Applicability / When to Use

• AIM 7351731 applies when a medical electrical device or system is likely to be exposed to emissions from RFID readers — particularly if the device is located in close proximity (e.g., within ~20 cm) of an RFID reader, or where the reader’s output power is significant.
• If the medical equipment will not be exposed to RFID readers (or risk assessment shows negligible exposure), the manufacturer may justify that full AIM 7351731 testing is not required — but the risk must be documented.
• Note: Even if full AIM testing is not required, baseline EMC immunity (e.g., IEC 60601-1-2) remains required.

Related standards and test methods

• Magnetic field immunity 9 kHz to 150 kHz - See Application Note 138: "How to perform a magnetic field close proximity test"
• Magnetic field immunity 150 kHz to 26 MHz - See Application Note 139: "How to perform a magnetic field close proximity test using forward power levelling"
• IEC 60601-1-2
• IEC 61000-4-39

Links

• AIM Store for AIM 7351731

The ability of an EUT to be immune to incoming electromagnetic interference. This is equivalent to the term susceptibility that is used by some standards.

Radio-Frequency IDentification

Institute of Electrical and Electronics Engineers

The ability of an EUT to be immune to incoming electromagnetic interference. This is equivalent to the term susceptibility that is used by some standards.

ElectroMagnetic Compatibility