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Compliance

Cibesmed Sàrl provides an exceptional service, combined with a dedication to quality and efficiency

All Cibesmed products conform to all regulations concerning the transport of infectious and diagnostic specimens. Our systems are tested to IATA Perishable Goods Regulations (PGR) and USP1079 standards, as well as being compliant with IATA, UN, ADR, CFR49, US DOT, Trans Canada Dangerous Goods (DG) and the World Health Organization (WHO).
We have specialised staff able to advise the specific regulatory needs of Biological, Medical, Pharmaceutical, Veterinary & Clinical Waste sectors. We provide literature on the regulations and are able to provide individual transport solutions that comply with the regulations.

UN COMPLIANT CATEGORIES:

UN 2814 CATEGORY A INFECTIOUS SUBSTANCES AFFECTING HUMANS (PI: P620)
UN 2900 CATEGORY A INFECTIOUS SUBSTANCES AFFECTING ANIMALS (PI: P620)
UN 3373 CATEGORY B BIOLOGICAL SUBSTANCES (PI: P650)
UN 3291 CLINICAL WASTE (PI: P621)

UN COMPLIANT CATEGORIES:

There are four UN numbers that can be used to classify goods that contain infectious substances or pathogens, as dangerous goods for transport:

  • UN 2814, Infectious Substances (affecting humans)
  • UN 2900, Infectious Substances (affecting animals)
  • UN 3291, Clinical Waste (Bio Medical Waste or Regulated Medical Waste)
  • UN 3373, Diagnostic Specimens

Infectious Substances

Generally speaking, if your goods are reasonably known to contain a pathogen (including certain bacteria, viruses, parasites, etc.), and the pathogens cause infectious diseases in humans, or animals and humans, then UN 2814 should normally be used to classify the substance, unless the goods meet the criteria of one of the other three UN numbers listed above. If the pathogens are known to affect animals, but not humans, then UN 2900 can be used. For carriage under UN 2814, UN 2900 and UN 3373, you will need to determine the risk category associated with the pathogens. You will need to refer to the current text of ADR at 2.2.62 to find out how to allocate a category. It is then necessary to determine how to package the goods by reference to packing instruction P620 and paragraph 4.1.8 of ADR.

Clinical Waste

Where there is a low probability of pathogens being present (i.e. you cannot specify them and there is no reason to believe that there are any), and the materials are waste products derived from research or the medical treatment of humans or animals, then the materials can be classified as UN 3291 . If you are aware that the waste has come from an infected human or animal, then you should assign either UN 2814 or UN 2900, as appropriate. If infectious waste has been suitably treated, then it is possible that the waste will no longer be considered infectious and can be carried under UN 3291. Packaging requirements are at packing instruction P 621.

Diagnostic Specimens

Diagnostic specimens, assigned to UN 3373, are human or animal materials that are being transported only for the purpose of diagnosis or investigation. Such materials include excreta, blood and its components, as well as other tissues and fluids. Diagnostic specimens do not include live infected animals. Packaging requirements are at packing instruction P 650. Note that by Special Provision 319, if this packing instruction is met in full, no other ADR provisions apply. If the source (the patient) is known to have a serious disease that can be readily transmitted and for which effective treatment and preventative measures are not usually available, then the substance must be assigned UN 2814 or UN 2900, as appropriate.

Please note

You should refer to the current text of ADR to be sure that you have classified your goods correctly, have taken account of any special provisions and have packaged the goods in accordance with the relevant packing instructions.