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Specific UN transport regulations must be met when moving Category A and B Infectious samples. The requirements vary depending on the country, mode of transportation; classification and conditioning of the specimen. They are designed to ensure that samples arrive at their destination in good condition and present no hazard to persons or animals during transport.

DGP’s products are tested and certified to meet the appropriate UN regulations and the associated packing instructions. Our packaging is continually reviewed and updated to meet with the various packing instruction amendments.

Within the U.S. an infectious substance is regulated as a hazardous material under the U.S. Department of Transportation's (DOT's) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. An infectious substance must confirm to all applicable HMR requirements when offered for transportation or transported by air, highway, rail, or water.

Please note that any Infectious Substances transported internationally by air from the U.S. must adhere to IATA transport regulations (not the DOT's HMR).  Please contact us if you would like to receive further information on the IATA regulations compliance@dgpgroup.com.

An Introduction to the Classifications and Packing Guidelines

Packaging for Category A and B Infectious specimens must comprise of 3 packaging layers:





Primary/Inner Packaging (e.g. evacuated tubes; sample pouch; universal pots): Primary must be leak-proof (liquids) or siftproof (solids) and primary or secondary must withstand an internal pressure of 95kPa when being transported by air.





Absorbent (e.g. absorbent material, 4 bay pouch): For liquids, there must be absorbent sufficient to absorb entire contents contained in primary packaging. Multiple primaries must be individually wrapped or separated in order to prevent contact between them.


Secondary Packaging (e.g. pouch/bag, container): Secondary must be leak-proof (liquids) or siftproof (solid) and secondary or primary must withstand an internal pressure of 95kPa if being transported by air.


Outer Packaging (e.g outer box): Rigid outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100mm x 100mm. Also to contain suitable cushioning material and be clearly marked appropriately.






The combination of the 3 components must be submitted to various tests and certified to meet performance and technical criteria, such as internal pressure differential; temperature tolerance; strength; dimensions etc.


Infectious Substances: Those substances known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses rickettsia, parasites, fungi) and other agents such as prions, which can cause infectious disease in animals or humans.

Infectious substances are divided into two categories:

Category A: An infectious substance which is carried in form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to otherwise healthy humans or animals when exposure to it occurs. Infectious substances meeting these criteria which cause disease in humans and shall be assigned to UN 2814. The proper shipping name is Infectious substances, affecting humans.  Infectious substances which cause disease only in animals shall be assigned to UN 2900.  The proper shipping name for this is Infectious substances, affecting animals.  Packaging for a Category A Infectious Substance must meet the test standards of 49CFR178.609 and must be marked in conformance with 49CFR178.503(f). Additional packaging requirements can be found in 49CFR173.196(b). 

Category B: An infectious substance not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.  This includes Category B Infectious Substances transported for diagnostic or investigational purposes.  The proper shipping name is Biological Substance, Category B and these are assigned to the UN 3373.  Packaging for a Category B Infectious Substance must adhere to the the packaging requirements of 49CFR173.199.

Other Division 6.2 Infectious Substance definitions include:

Biological Products: A virus, therapeutic serum, toxin, antitoxin, caccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals.

Cultures: An Infectious substance containing a pathogen that is intentionally propagated.  Culture does not include a human or animal patient specimen as defined below.

Patient Specimen: Human or animal materials collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention.  Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media and blood culture bottles).


 Please click icon to download our A3 'Route to Compliance' chart.