Definitions. The categories of materials that constitute Division 6.2 are defined as follows:
An infectious substance means a viable microorganism, or its toxin, that causes or may cause disease in humans or animals, and includes those agents listed in 42 CFR 72.3 of the regulations of the Department of Health and Human Services and any other agent that causes or may cause severe, disabling or fatal disease. The terms infectious substance and etiologic agent are synonymous.
A diagnostic specimen means any human or animal material including, but not limited to, excreta, secreta, blood, blood components, tissue, and tissue fluids, being shipped for purposes of diagnosis.
A biological product means a material that is prepared and manufactured in accordance with the provisions of 9 CFR part 102 (Licenses for biological products), 9 CFR part 103 (Experimental products, distribution, and evaluation of biological products prior to licensing), 9 CFR part 104 (Permits for biological products), 21 CFR part 312 (Investigational new drug application), or 21 CFR parts 600 to 680 (Biologics).
A regulated medical waste means a waste or reusable material, other than a culture or stock of an infectious substance, that contains an infectious substance and is generated in:
The diagnosis, treatment or immunization of human beings or animals;
Research pertaining to the diagnosis, treatment or immunization of human beings or animals; or
The production or testing of biological products.