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BOX, triple packaging, biological substance UN3373 +pouch

https://unicat.msf.org/cat/product/17533
STD STSSUN62DS-

Valid Article

Former Code(s): PPACUN62DS- PPACUN62BT- STSSDS-
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, biological substance UN3373

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Definition

Box with UN approved triple packaging system, used for the transport of CATEGORY B samples, i.e. biological substances for diagnostic.

Meets the IATA packaging instructions 650.

(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
  • Hermetic seal (if necessary, fix the cap with sealing film) and to be labelled with a permanent marker

2. Secondary container

  • Pouch polyethylene, waterproof with adhesive closure, 20 x 30 cm (STSSUN62WB-) or plastic container 14.8 cm (h) X 13 cm (Ø) (STSSCONP130P)
  • The plastic container (not the pouch) is the right packaging choice for settings where the temperatures outside are above 28°C
  • Can contain several primary containers
  • Resist to a differential pressure of 95KPa
  • Provided with an absorbent sheet: can absorb all the fluid in case of leakage or breakage

3. Third /Outer container

  • Strengthened cardboard box used to protect the secondary container
  • Labelling UN 3373
  • 26.5 x 10.5 x 11.5 cm

Instructions for use

Mandatory minimum packaging for any sample of biological substance (blood, CSF, sputum, biopsy…), examples:

  • For diagnosis of tuberculosis: sputum in a dry tube (ELABTUCE5SPP).
  • For diagnosis of meningitis: (CSF in Trans-Isolate transport medium, or if not available in Amies Agar Charcoal medium).
  • For the diagnosis of Cholera (Stool in Cary blair medium)

The plastic container (not the pouch) is the suitable packaging option on settings with external temperatures above 28°C.

Transport of samples

Biological substances are shipped by DHL.

MSF requirements

Mandatory packaging for shipping biological substances (Category B (with out the need for cold chain)), with every means of transport.

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