BOX ISOTHERMAL, triple pack., infectious substance UN2814

STD STSSUN62ISI

Valid Article

Former Code(s): PPACUN62ISI PPACUN62MIT STSSISI
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
W05020102 - Samples transport, boxes
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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BOX ISOTHERM, infectious substance UN2814

Definition

Box with UN approved triple packaging system, used for the transport of CATEGORY A samples, i.e. infectious substance, affecting humans.

NB: All the pathogenic agents cultures are included in this category.

Isotherm box, allowing to keep the samples between 2º and 8ºC for 72 hours, or below -20°C with dry ice.

Meets the packaging instructions 602 and 954 (dry ice).

(Cf Procedures for transporting samples)

Specifications

Technical specifications

The system consists of 3 containers/ layers of packaging:

1. Primary container

  • Tube or vial containing the sample (MAXIMUM 50 ml !)
  • Hermetic seal (if necessary, fix the cap with sealing film) to be labelled with a permanent marker

2. Secondary container

  • Watertight polyethylene cylinder box intended to protect the primary container
  • Screw cap with gasket
  • Supplied with:
    • bubble paper vial holder in which several primary containers can be placed
    • a sheet of absorbent can absorb all the fluid in case of breakage
  • Ø 12.5 cm, H 14.5 cm
  • Maximum volume: 1.8 litre

3. Third/Outer container

  • Strengthened cardboard box used to protect the secondary container
  • Insulation: inner molded polystyrene box
  • Labelling UN2814
  • Designed to hold 4 icepacks 0.6 liter
  • Can be used with dry ice, a sticker IATA class 9 is supplied
  • 15 x 16.5 x 20.5 cm

Instructions for use

Mandatory minimum packaging for any sample in case of suspicion of:

The total quantity of sample must not exceed 50 ml.

Boxes that transported infectious substances must not be reused.

Transport of samples

Infectious substances UN2814 are refused by DHL and must be shipped by air transport.

MSF requirements

Mandatory packaging for shipping infectious substances categorized UN2814 (category A) by cold chain by air transport.

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