Quick answer: In Canada, biological specimen transport follows the Transportation of Dangerous Goods framework, and in the United States it follows the Department of Transportation hazardous materials rules. Both allow a Category B biological substance such as a diagnostic specimen to travel in a compliant three-layer packaging system marked UN3373. The differences are in the citation, the documentation and some labelling details, so a lab shipping across the border needs both rule sets rather than one.
What packaging does a Category B specimen require?
The standard system has three layers: a primary leakproof receptacle holding the specimen, absorbent material around it, and a rigid outer package. The whole assembly must pass a drop and pressure test, and it must be marked with the UN3373 designation for a Category B biological substance.
For a Category A infectious substance, the requirements are stricter and the marking differs. The classification decision therefore comes before the packaging decision, because the packaging follows the category.
How do the two rule sets compare?
Both countries accept the UN3373 three-layer approach, and both require the shipper to be trained on the regulations. Documentation and labelling details differ, and a shipment that crosses the border has to satisfy the rules on both sides. That means the outer package, the documentation and the training records need review against the destination rules, not just the origin ones.
For domestic shipments, the practical burden is lighter, but the packaging and marking requirements still apply.
| Item | Canada | United States |
|---|---|---|
| Framework | Transportation of Dangerous Goods regulations | Department of Transportation hazardous materials rules |
| Category B marking | UN3373 | UN3373 |
| Category A marking | Distinct marking for infectious substances | Distinct marking for infectious substances |
| Packaging layers | Primary, absorbent, rigid outer | Primary, absorbent, rigid outer |
| Shipper training | Required | Required |
| Documentation | Per the Canadian rule set | Per the US rule set |
What information belongs on the package and the paperwork?
The outer package carries the UN3373 marking and the shipper and consignee details. The paperwork identifies the substance, the category and the responsible person. Where a courier is used, the courier's own requirements sit on top of the regulatory ones, so the clinic should confirm both before the first shipment.
Keeping a copy of the classification decision and the training record for the responsible person is part of the compliance picture, not an optional extra.
What mistakes do labs make?
The most common error is using three-layer packaging without the correct marking or with the wrong category classification. The second is a shipper who has not been trained, which undermines the whole chain even when the packaging is right. A third is assuming that a domestic practice transfers unchanged to a cross-border shipment.
Ambiguous classification is the root of most of these: a clinic that is unsure whether a specimen is Category A or B cannot choose the right packaging, marking or documentation.
How should a lab build a transport routine?
Start with the classification. Write a short decision rule for the specimen types the lab handles, and record the classification decision for each. Specify one compliant packaging system for Category B and a separate, stricter specification for Category A where the lab handles such material. Train the shipper and keep the record current.
Then audit the routine annually against both rule sets if the lab ships across the border. Rules change, courier requirements change, and a packaging system that met the standard three years ago may no longer be the version the lab is actually receiving from its supplier.
It is worth keeping a stock of compliant packaging rather than assembling it ad hoc. A lab that has to source an outer package at the moment a shipment is due is more likely to substitute a box that looks adequate than to wait. Keeping the primary receptacle, the absorbent and the rigid outer in one stocked kit removes that temptation and makes training simpler, because the shipper assembles the same components every time. Where the lab handles both Category A and Category B, keep the two kits separate and clearly labelled, so the stricter packaging is never confused with the standard one.
How does transport connect to the clinic's other obligations?
The transport routine sits at the end of the specimen chain, after collection and handling. A lab that manages transport well but leaves gaps in its reprocessing records still has an incomplete compliance picture.
In Ontario, the RCDSO expects a biological indicator for each sterilizer on every day it is used — daily monitoring, not weekly. Transport and reprocessing are separate obligations, but both belong in the same laboratory manual, and an inspection will ask for both.
How does a clinic train staff on packaging without over-teaching?
Packaging is one of the few tasks in a clinic where a single wrong step invalidates the whole shipment, so training has to be practical rather than legalistic. The workable approach is a one-page visual card at the packing bench showing the components, the closure and the label side, followed by a supervised first pack for every new staff member. The card answers the question that actually comes up under time pressure, which is which component goes where, not which regulation applies.
Reinforce it with a short annual review and a signed training record. Where a clinic ships to a reference laboratory, add the carrier paperwork to the same review, because the documentation that travels with the package is part of the same duty and is frequently the item that a reviewer asks for first.
Related reading
Sterilization compliance hub; choosing UN3373 Category B packaging; specimen transport bag requirements; 95kPa bags vs three-wall transport bags; laboratory consumables collection; BI 5-pack trial.
Download the specimen classification and transport checklist from the compliance log centre, run the sterilization self-check to review your laboratory records, and book a sterilization compliance consultation if your manual needs updating.
Ordering for a lab, clinic or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers. Reselling? become a distributor.
Frequently Asked Questions
What is UN3373 used for?
It marks a Category B biological substance, such as a diagnostic specimen, in a compliant three-layer packaging system.
Is the packaging the same in Canada and the US?
The three-layer approach and the UN3373 marking are shared, but the rule sets, documentation and some labelling details differ, so cross-border shipments must satisfy both.
Who needs training to ship specimens?
The shipper must be trained on the applicable regulations and the training record kept. Both countries require it.
What is the most common transport error?
Getting the category classification wrong, which leads to the wrong packaging, marking and documentation for the shipment.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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