What Are the Key International Regulations for Specimen Transport Bags?
- Adsure Medical packaging

- Dec 11, 2025
- 3 min read
When transporting biological specimens, ensuring their safe and compliant transport is of utmost importance. But what are the key international regulations that govern specimen transport bags? And why are these rules essential for ensuring safety? Let’s explore the major guidelines, including UN3373, IATA P650, ICAO, and the 95kPa pressure standard, that make biological specimen shipping secure and compliant with global standards.
What Are the Key International Regulations for Specimen Transport Bags?
There are several international regulations that define the requirements for transporting biological specimens safely. These standards ensure the proper packaging, labeling, and handling of specimens during transport, minimizing the risk of exposure to hazardous substances. Here are the key regulations that matter:
What is UN3373? – Biological Substance, Category B

UN3373, a regulation set by the United Nations, applies to the transport of biological specimens that are not classified as infectious but still require special handling due to potential risks. Transport bags for biological substances must comply with the UN3373 guidelines to ensure safe transport.
Key aspects of UN3373 include:
Triple Packaging System: Specimens must be placed in a leak-proof primary container, surrounded by absorbent material, and then enclosed in an outer durable container.
Labeling: The specimen bags must be clearly labeled with the UN3373 marking, showing the substance’s category and handling instructions.
What Does IATA P650 Cover? – Air Transport of Biological Substances

IATA P650, established by the International Air Transport Association, specifies packaging instructions for the safe air transport of biological substances. The guidelines emphasize minimizing risks such as leakage or contamination during air travel.
Key requirements for IATA P650 include:
Leak-Proof Primary Containers: Ensuring that the primary containers do not leak during transport.
Triple Packaging: Like UN3373, IATA P650 mandates the use of three layers of packaging to prevent leaks.
Clear Labeling: Specimens must be properly labeled with all necessary handling and content information.
How Do ICAO Regulations Affect Specimen Transport?

The International Civil Aviation Organization (ICAO) establishes global standards for the safe air transport of biological substances. ICAO regulations align with IATA’s rules, with an added emphasis on the 95kPa standard for air transport.
The 95kPa standard ensures that specimen transport bags can withstand the pressure changes encountered during air travel, which can significantly alter atmospheric pressure at high altitudes. Packaging must remain intact and secure even under these conditions.
2. Why Are These Regulations Important?
Understanding the significance of these international regulations is crucial for safe specimen transport. Here are the main reasons why these rules are in place:
Safety and Containment of Hazardous Materials
Biological specimens may carry infectious agents or other hazardous materials. The packaging regulations, including the leak-proof containers, absorbent materials, and robust outer packaging, prevent these substances from posing a risk to the public or transport workers.
Ensuring Compliance Across Borders
For organizations shipping specimens internationally, adhering to these regulations ensures that their shipments meet global safety standards. Compliance helps avoid legal complications, fines, or delays during transportation.
Preventing Contamination and Exposure
The triple packaging system is designed to contain any potential leaks or spills, ensuring that biological materials do not contaminate other cargo or cause harm to others during transit.
Consistency and Predictability in International Shipments
By following internationally recognized regulations, businesses can ensure that their shipments will be accepted and processed smoothly by customs and transport companies across different countries.
Conclusion
International regulations like UN3373, IATA P650, and ICAO’s 95kPa standard are essential for the safe and compliant transport of biological specimens. These guidelines safeguard both the specimens and the people involved in their handling. By adhering to these standards, businesses can ensure secure and reliable transport, whether they are shipping domestically or internationally.



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