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 comply with 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, and
with at least one surface having minimum dimensions of 100 mm × 100 mm;
(b) For liquids, absorbent material in sufficient quantity to absorb the entire contents is placed
between the primary receptacle(s) and the secondary packaging so that, during carriage, any
release or leak of a liquid substance will not reach the outer packaging and will not
compromise the integrity of the cushioning material;
(c) When multiple fragile primary receptacles are placed in a single secondary packaging, they are
either individually wrapped or separated to prevent contact between them.
NOTE 1: 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 animals in the absence of any concern
for infection (e.g. evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc.).
NOTE 2: For air transport, packagings for specimens exempted under this paragraph shall meet the
conditions in (a) to (c).

 

Except for:
(a) Medical waste (UN No. 3291);
(b) Medical devices or equipment contaminated with or containing infectious substances in
Category A (UN No. 2814 or UN No. 2900); and
(c) Medical devices or equipment contaminated with or containing other dangerous goods that
meet the definition of another class,
medical devices 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 ADR other 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 4.1.1.1 and 4.1.1.2 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 MEDICAL
EQUIPMENT". When using overpacks, these shall be marked in the same way, except when the
inscription remains visible.

(Reserved)

(Reserved)

(Reserved)

Biological products

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 of
appropriate 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 this
group are not subject to the provisions of ADR;
(b) those which do not fall under paragraph (a) and are known or reasonably believed to contain
infectious substances and which meet the criteria for inclusion in Category A or Category B.
Substances in this group shall be assigned to UN Nos. 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 and organisms

Genetically modified microorganisms not meeting the definition of infectious substance shall be
classified according to section 2.2.9.

Medical or clinical wastes

Medical or clinical wastes containing Category A infectious substances shall be assigned to UN No.
2814 or UN No. 2900 as appropriate. Medical or clinical wastes containing infectious substances in
Category B shall be assigned to UN No. 3291.
NOTE: Medical or clinical wastes assigned to number 18 01 03 (Wastes from human or animal
health care and/or related research – wastes from natal care, diagnosis, treatment or prevention of
disease in humans – wastes whose collection and disposal is subject to special requirements in order
to prevent infection) or 18 02 02 (Wastes from human or animal health care and/or related research –
wastes from research, diagnosis, treatment or prevention of disease involving animals – wastes whose
collection and disposal is subject to special requirements in order to prevent infection) according to
the list of wastes annexed to the Commission Decision 2000/532/EC4 as amended, shall be classified
according to the provisions set out in this paragraph, based on the medical or veterinary diagnosis
concerning the patient or the animal.

infectious substances shall be assigned to UN No. 3291. For the assignment, international, regional or
national waste catalogues may be taken into account.
NOTE 1: The proper shipping name for UN No. 3291 is "CLINICAL WASTE, UNSPECIFIED,
N.O.S." or "(BIO) MEDICAL WASTE, N.O.S". or "REGULATED MEDICAL WASTE, N.O.S.".
NOTE 2: Notwithstanding the classification criteria set out above, medical or clinical wastes
assigned to number 18 01 04 (Wastes from human or animal health care and/or related research –
wastes from natal care, diagnosis, treatment or prevention of disease in humans – wastes whose
collection and disposal is not subject to special requirements in order to prevent infection) or
18 02 03 (Wastes from human or animal health care and/or related research – wastes from research,
diagnosis, treatment or prevention of disease involving animals – wastes whose collection and
disposal is not subject to special requirements in order to prevent infection) according to the list of
wastes annexed to the Commission Decision 2000/532/EC5 as amended, are not subject to the
provisions of ADR.

Decontaminated medical or clinical wastes which previously contained infectious substances are not
subject to the provisions of ADR unless they meet the criteria for inclusion in another class.

Medical or clinical wastes assigned to UN No. 3291 are assigned to packing group II.

Infected animals

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