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Eidgenössische Ethikkommission für die Biotechnologie im Ausserhumanbereich EKAH

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Homepage  >  Transport, import, exp...  >  Transport sheets  >  1.1 Human pathogens an...  >  Transport sheet 1.1.1b

 

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Patient specimens of Category A human pathogens and zoonotic agents marked with "cultures only"

1. Definition

Transport of

  • Patient specimens of pathogens listed as category A infectious substances according to ADR 2.2.62.1.4.1, but marked with "cultures only", do not require category A transport practices as stated under transport sheet 1.1.1.a. For these patient specimens Category B transport practices as listed in this transport sheet can be applied.

Relevant documents:

2. Risk

Physical contact with humans or animals capable of causing disease which is neither life-threatening nor fatal in otherwise healthy humans or animals.

3. Biological substances not to be transported

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4. UN name & number

  • Biological substance, Category B
  • UN 3373

Relevant documents:

5. Permits (CH, import, export)

Cultures of epizootic agents (Ordinance on epizootics) may only be sent to the Institute for Viral Diseases and Immune Prophylaxis or to institutions having a permit to handle such pathogens (Vademecum IVI).

Import: A voluntary import certificate can be received from the Office for Public Health (Voluntary import certificate form).

Export: Export permits (SECO export permit form) from SECOextern_icon are necessary for pathogens which could be used as biological weapons (SECO list of human pathogens IC351), if their value exceed 1000 Swiss francs.

Import permit for the importing country according to the requirement of the competent authorities.

Relevant documents:

6. Packaging

The packaging shall be of good quality, strong enough to withstand the shocks and loadings normally encountered during carriage, including transshipment between vehicles or containers as well as any removal from an overpack. Packaging shall be constructed and closed to prevent any loss of contents:

  • leak-proof (for liquids, powders) primary receptacle(s);
  • leak-proof (for liquids, powders) secondary packaging and
  • an outer packaging, with a smallest external dimension of not less than 100 mm;
  • either the secondary or preferably the outer packaging has to be rigid;
  • for liquids: absorbent material between primary receptacle and secondary packaging to fully absorb liquid in case of leak or breakage;
  • when multiple fragile primary receptacles are placed in a single secondary packaging, they are either individually wrapped or separated to prevent contact between them;
  • coolants have to be packed around secondary packaging, packaging has to maintain its integrity in the presence of the coolant, if solid carbon dioxide (dry ice) is used packaging has to permit the release of carbon dioxide gas;

  • for air transport only:
    • the primary receptacle or secondary packaging must be capable of withstanding, without leakage, an internal pressure of 95 kPa in the range of -40° C to 55° C.
    • for liquids: no primary receptacle shall exceed 1 l and the outer packaging must not contain more than 4 l
    • for solids: the outer packaging must not contain more than 4 kg (expect body parts, organs and whole bodies). 

Note: Substances packed and packages which are marked in accordance with packing instruction P650 are not subject to any other requirement of ADR.

Relevant documents:

7. Labelling and marking

  • Name and address of consigner and consignee
  • Proper shipping name: BIOLOGICAL SUBSTANCE, CATEGORY B (at least 6 mm high)
  • Mark: diamond-shaped mark with minimum dimensions of 50mm by 50mm containing the UN number UN 3373 (at least 6 mm high)
  • If solid carbon dioxide is used: ‘Carbon dioxide, solid’ or ‘dry ice’ 
  • If liquid nitrogen is used: Hazard label for non-flammable, non-toxic gases

For air transport:

  • Name and address of consigner and consignee
  • Phone number of responsible person
  • Proper shipping name: BIOLOGICAL SUBSTANCE, CATEGORY B (at least 6 mm high)
  • UN number: UN 3373
  • Mark: diamond-shaped mark with minimum dimensions of 50mm by 50mm containing the UN number UN 3373 (at least 6 mm high)
  • If solid carbon dioxide is used: ‘Carbon dioxide, solid’ or ‘dry ice’, UN 1845, net quantity, class 9 hazard label
  • If liquid nitrogen is used:
    • Hazard label for non-flammable, non-toxic gases
    • Handling label for cryogenic liquids

Relevant documents:

8. Transport documents

  • Delivery note / (pro forma) invoice for customs and
  • Itemized list of contents between secondary packaging and outer packaging
  • Required permits
  • Airway bill for air transport (form provided and filled out by carrier), showing "UN 3373", the text "BIOLOGICAL SUBSTANCE, CATEGORY B" and the number of packages in the "Nature and Quantity of Goods" box, and / or equivalent documents for the transport by road.

Note: A shipper's declaration for dangerous goods is not required for Category B infectious substances!

Relevant documents:

9. Carriers

Private transport, Swiss Post (national) or carrier.


Last updated on: 30.06.2011




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