Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to the provisions of ADR unless they meet the criteria for inclusion in another class.
Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to ADR unless they meet the criteria for inclusion in another class.
Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to ADR unless they meet the criteria for inclusion in another class.
NOTE:Medical equipment which has been drained of free liquid is deemed to meet the requirements of this paragraph and is not subject to the provisions of ADR.
Substances where the concentration of pathogens is at a level naturally encountered (including foodstuff and watersamples) and which are not considered to pose a significant risk of infection are not subject to ADR unless they meet the criteria for inclusion in another class.
Dried blood spots, collected by applying a drop of blood onto absorbent material, are not subject to ADR.
Faecal occult blood screening samples are not subject to ADR.
Blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation as well as samples drawn in connection with such purposes are not subject to ADR.
Human or animal specimens for which there is minimal likelihood that pathogens are present are not subject to ADR if the specimen is carried in a packaging which will prevent any leakage and which is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate.
The packaging is deemed to complywith the above requirements if it meets the following conditions:
(a)The packaging consists of three components:
(i)a leak-proof primary receptacle(s);
(ii)a leak-proof secondary packaging; and
(iii)an outer packaging of adequate strength for its capacity, mass and intended use, andwith at least one surface having minimum dimensions of 100mm× 100mm;
(b)For liquids, absorbent material in sufficient quantity to absorb the entire contents is placedbetween the primary receptacle(s) and the secondary packaging so that, during carriage, anyrelease or leak of a liquid substance will not reach the outer packaging and will notcompromise the integrity of the cushioning material;
(c)When multiple fragile primary receptacles are placed in a single secondary packaging, they areeither individually wrapped or separated to prevent contact between them.
NOTE1:An element of professional judgment is required to determine if a substance is exempt under this paragraph. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be carried under this paragraph include the blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antibodies (PSA); those required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or for therapeutic drug monitoring; those conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy test; biopsies to detect cancer; and antibody detection in humans or animalsin the absence of any concern for infection (e.g. evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc.).
NOTE2:For air transport, packagings for specimens exempted under this paragraph shall meet the conditions in (a) to (c).
(a)Medical waste (UN No. 3291);
(b)Medical devices or equipment contaminated with or containing infectious substances inCategory A (UN No. 2814 or UN No. 2900); and
(c)Medical devices or equipment contaminated with or containing other dangerous goods thatmeet the definition of anotherclass,
medicaldevices or equipment potentially contaminated with or containing infectious substances which are being carried for disinfection, cleaning, sterilization, repair, or equipment evaluation are not subject to provisions of ADRother than those of this paragraph if packed in packagings designed and constructed in such a way that, under normal conditions of carriage, they cannot break, be punctured or leak their contents. Packagings shall be designed to meet the construction requirements listed in 6.1.4 or 6.6.4.
These packagings shall meet the general packing requirements of 126.96.36.199 and 188.8.131.52 and be capable of retaining the medical devices and equipment when dropped from a height of 1.2 m.
The packagings shall be marked "USED MEDICAL DEVICE" or "USED MEDICALEQUIPMENT". When using overpacks, these shall be marked in the same way, except when the inscription remains visible.
For the purposes of ADR, biological products are divided into the following groups:
(a) those which are manufactured and packaged in accordance with the requirements ofappropriate national authorities and carried for the purposes of final packaging or distribution,and use for personal health care by medical professionals or individuals. Substances in thisgroup are not subject to the provisions of ADR;
(b) those which do not fall under paragraph (a) and are known or reasonably believed to containinfectious substances and which meet the criteria for inclusion in Category Aor Category B.Substances in this group shall be assigned to UNNos.2814, 2900 or 3373, as appropriate.
NOTE:Some licensed biological products may present a biohazard only in certain parts of the world. In that case, competent authorities may require these biological products to be in compliance with local requirements for infectious substances or may impose other restrictions.
Genetically modified microorganisms not meeting the definition of infectious substance shall be classified according to section 2.2.9.