General Requirements. Shippers of diagnostic specimens where a relatively low probability exists that infectious substances are present (diagnostic specimens being transported to undergo routine screening tests or for the purpose of initial diagnosis may be considered to fall under this category) must comply with these Regulations. The shipper must also ensure that shipments are prepared in such a manner that they arrive at their destination in good condition and that they present no hazard to persons or animals during shipment. The packaging must include:

Inner packagings comprising:

• a watertight primary receptacle(s) - for diagnostic specimens the maximum quantity must not exceed 500 ml;
• a watertight secondary packaging - the maximum quantity per outer packaging for diagnostic specimens must not exceed 4 L;
• an absorbent material - must be placed between the primary and the secondary packaging. No absorbent material is required when shipping solid substances.

If multiple primary receptacles are placed in a single secondary packaging they must be wrapped individually or for those transported in liquid nitrogen, separated and supported to ensure that contact between them is prevented.

The absorbing material, for example cotton wool, must be sufficient to absorb the entire contents of all primary receptacles.

Outer packaging of adequate strength for its capacity, weight, and intended use.

However, each completed package must be capable of successfully passing the drop test described in 6.5.1 except that the height of the drop must not be less than 1.2 meters.

The primary receptacle, or the secondary packaging used for liquid diagnostic specimens, must be capable of withstanding-- without leakage, an internal pressure which produces a pressure differential of not less than 95kPa (0.95 bar, 13.8 lb/in2) in the range of –40 degrees C to +55 degrees C (-40 degrees F to 130 degrees F). It is not necessary for the primary or secondary packaging to be capable of withstanding 95 kPa pressure differential when solid diagnostic specimens are being shipped.

Packages consigned as freight must be at least 100 mm (4 in.) in the smallest overall external dimension.

An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.

Each package and the "Nature and Quantity of Goods" box of the air waybill must show the text "DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650"

A shippers declaration of dangerous goods is not required.

Specific Requirements

Although exceptional cases, (for example, the shipment of whole organs) may require special packaging, the great majority of diagnostic specimens can and must be packaged according to the following guidelines.

Substances shipped at ambient temperatures or higher: Primary receptacles include those of glass, metal or plastic. Positive means of ensuring a leak-proof seal, such as heat seal, skirted stopper, or metal crimp seal must be provided. If screw caps are used these must be reinforced with adhesive tape.

Substances shipped refrigerated or frozen (wt ice, pre-frozen packs, Carbon dioxide, solid [dry ice]; Ice Carbon dioxide, solid (dry ice) or other refrigerant must be placed outside the secondary packaging(s) or alternatively in an overpack with one or more completed packagings marked in accordance with 6.06. Interior support must be provided to secure the secondary packagings(s) in the original position after the ice or Carbon Dioxide has been dissipated. If ice is used, the packaging must be leak-proof. If Carbon dioxide, solid (dry ice) is used the outer packaging must permit the release of carbon-dioxide gas. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost.

Substances shipped in liquid nitrogen: Plastic capable of withstanding very low temperatures must be used instead of glass receptacles. Secondary packaging must also withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. Requirements for shipment of liquid nitrogen must also be observed. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant used as well as at the temperatures and pressure of air transport to which the receptacle could be subjected to if refrigeration were to be lost.

Lyophilized substances: Primary receptacles must be either flame-sealed glass ampoules or rubber-stoppered glass vials with metal seals.