Shipping Medical Devices with Lithium Batteries: UN3481, UN3091, and IATA DGR Basics

Modern medical equipment — infusion pumps, portable ultrasound units, patient monitors, defibrillators, portable oxygen concentrators, and surgical handpieces — increasingly rely on lithium metal or lithium-ion batteries for backup or primary power. Because lithium cells can overheat, ignite, or short-circuit under mechanical, thermal, or electrical stress, international transport law classifies them as Class 9 dangerous goods. For exporters and importers of used and refurbished medical equipment, understanding these rules is not optional: non-compliant shipments can be refused by carriers, seized by customs, or — in the worst case — become a safety incident during transport.

This article summarizes the core shipping rules that apply when lithium batteries are installed in, or packed alongside, medical devices destined for hospitals and distributors abroad.

Why Lithium Batteries Are Regulated

Lithium metal (non-rechargeable) and lithium-ion (rechargeable) batteries store significant energy in a small volume. If damaged, short-circuited, overcharged, or exposed to extreme heat, they can undergo thermal runaway — rapid, self-sustaining heat generation that can lead to fire. Because this risk is elevated in an aircraft cargo hold, both the IATA Dangerous Goods Regulations (based on the ICAO Technical Instructions) and U.S. domestic rules (PHMSA Hazardous Materials Regulations, 49 CFR Parts 171–180) impose classification, packaging, marking, labeling, and documentation requirements on virtually all shipments containing these batteries (PHMSA Lithium Battery Guide).

Every lithium cell and battery type must first pass design-qualification tests under the UN Manual of Tests and Criteria, Section 38.3 — altitude simulation, thermal cycling, vibration, shock, external short circuit, and crush tests. Manufacturers and distributors must be able to produce a test summary demonstrating compliance (IATA Lithium Batteries Fact Sheet).

The Four Lithium Battery UN Numbers

The U.S. Hazardous Materials Table lists lithium batteries under four proper shipping names, depending on chemistry and configuration (PHMSA Lithium Battery Guide):

For a medical equipment exporter, UN3481 (lithium-ion) and UN3091 (lithium metal) are the two most relevant classifications, since batteries are almost always shipped installed in, or packed alongside, the powered device rather than as loose spares.

A package may contain batteries "contained in equipment" or "packed with equipment" — the shipping name and packaging details differ slightly, and if a shipment includes both, the "packed with equipment" name governs the whole package.

State of Charge Requirements

State of charge (SoC) — how full the battery is relative to its rated capacity — is a key risk factor, because a fully charged battery releases more energy if it fails. Under IATA rules:

• Lithium-ion and lithium metal batteries shipped by themselves (UN3480/UN3090, not packed with or in equipment) must be at no more than 30% state of charge.
• Beginning 1 January 2026, batteries shipped packed with the equipment they power must also meet the 30% SoC limit (IATA Lithium Batteries Fact Sheet).
• Batteries installed inside a device (contained in equipment) are generally exempt from the 30% SoC rule, since the equipment's own protection circuitry is considered a mitigating factor — but exporters should always confirm current requirements with their forwarder, since airline variations (Operator Variations, or "OpVars") can be stricter than the base IATA rule.

Practical implication for Rotala International: whenever spare batteries are packed alongside a device rather than left installed, discharge them to 30% or less before packaging, and document the state of charge on the shipping paperwork.

Packaging Requirements

Packaging obligations differ depending on whether the shipment is "fully regulated" (large quantities/high watt-hour or gram content) or qualifies for the relaxed provisions available to smaller cells and batteries. Core requirements for UN3481 and UN3091 include (PHMSA Lithium Battery Guide):

• Battery terminals must be protected against short-circuiting.
• Cells and batteries packed with (not installed in) equipment must be placed in non-metallic inner packaging that fully encloses them and isolates them from conductive materials.
• Equipment must be secured against shifting and protected from accidental activation during transport.
• For fully regulated shipments, a UN specification outer packaging meeting Packing Group II performance requirements is required.
• For smaller cells/batteries within the relaxed thresholds, a strong, rigid outer package capable of passing a 1.2-meter drop test may be used instead of full UN specification packaging.
• The number of batteries in a package is limited to the minimum required to power the equipment, plus two spare sets at most.

Marking and Labeling

Even shipments that qualify for relaxed packaging still require hazard communication. Typical requirements include (PHMSA Lithium Battery Guide):

• Lithium Battery Mark: a hatched-border rectangle or square, minimum 100 mm × 100 mm (a smaller 100 mm × 70 mm version is allowed on small packages), showing the UN number (3481 or 3091) and a contact telephone number.
• Class 9 Lithium Battery label for fully regulated shipments.
• Cargo Aircraft Only (CAO) label if the package's lithium battery content exceeds 5 kg net weight, or if the shipment is otherwise restricted from passenger aircraft.
• Proper shipping name marked on the package ("Lithium ion batteries contained in equipment," etc.).
• Consignor/consignee name and address.
• As of May 10, 2024, lithium-ion batteries must be marked with their watt-hour (Wh) rating on the outer battery case.
• If overpacked, all marks and labels must be visible or reproduced on the overpack, which must also be marked "OVERPACK."

Section IA, IB, and II: Why the Distinction Matters

IATA's Dangerous Goods Regulations subdivide lithium battery packing instructions into sections (informally IA, IB, and II) based on cell/battery size and quantity, each carrying different documentation and training obligations. Fully regulated shipments (IA/IB) require a complete Shipper's Declaration for Dangerous Goods, dangerous goods training for personnel preparing the shipment, and full Class 9 labeling. Shipments qualifying for relaxed provisions (informally "Section II") are excepted from the shipping paper and formal declaration but still require the Lithium Battery Mark and adherence to packaging/quantity limits. Because thresholds and airline-specific variations change periodically, always confirm current packing instruction numbers with your IATA-trained freight forwarder or the current IATA DGR edition before finalizing packaging.

When Batteries Must Be Removed

Batteries should be removed from equipment, or shipped separately under the stand-alone UN3480/UN3090 classification, when:

• The device has a swollen, leaking, corroded, or physically damaged battery — damaged or recalled lithium batteries are not permitted for transport by any means until made safe or removed (FAA PackSafe Guidance).
• The receiving country's customs or health regulator restricts import of installed batteries (some destinations require batteries to arrive under separate, dedicated battery shipments due to local air carrier restrictions).
• The equipment will be stored for an extended period before shipment — extended storage at full charge accelerates degradation and increases risk; discharging or removing the battery is good practice.
• The device does not need power during transit and the manufacturer's service documentation recommends removal for shipping (common for certain infusion pumps and monitors).
• Total lithium battery content in a single package would exceed the net quantity limits for "packed with/contained in equipment" shipments (5 kg for passenger aircraft; 35 kg for cargo aircraft, absent an exemption).

When batteries are removed, they must still be classified, packaged, marked, and labeled as stand-alone lithium batteries (UN3480/UN3090) if shipped in the same consignment, and the equipment itself should be marked "battery removed" for the receiving technician's safety.

Shipper Responsibilities Checklist

• Confirm battery chemistry (lithium-ion vs. lithium metal) and Wh/gram content from the manufacturer's data sheet.
• Confirm state of charge is at or below 30% for any batteries not installed in the device (and for all batteries packed with equipment beginning January 2026).
• Verify the UN 38.3 test summary is available from the manufacturer or battery supplier.
• Select the correct UN number and proper shipping name (UN3481 or UN3091, "packed with" vs. "contained in").
• Package according to the applicable packing instruction (fully regulated vs. small-quantity provisions).
• Apply the Lithium Battery Mark, Class 9 label (if required), CAO label (if required), and Wh marking.
• Complete a Shipper's Declaration for Dangerous Goods if the shipment is fully regulated.
• Confirm the freight forwarder and airline accept lithium battery cargo on the intended routing.
• Remove or discharge batteries that are damaged, recalled, or restricted at destination.
• Retain all dangerous goods documentation and training records for audit purposes.