Exempt Human Specimen

Origin

The term was introduced into transport regulations to streamline the shipping of routine clinical and research samples without compromising safety. Its origin is a practical classification designed by regulatory bodies to distinguish between specimens posing a significant biohazard risk and those intended for non-infectious diagnostic or research purposes. This regulatory distinction facilitates the efficient global movement of non-hazardous biological materials essential for clinical trials and routine diagnostics.

Mechanism

The mechanism for exemption relies on a risk-based classification where the specimen is deemed non-infectious based on the known medical history of the source or the nature of the test being performed. Although exempt from certain strict rules, the specimen must still be triple-packaged in a leak-proof primary and secondary container with sufficient absorbent material. The outer packaging must be clearly marked with the phrase “Exempt Human Specimen,” ensuring proper handling throughout the entire logistics chain.