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BOX ISOTHERMAL, triple pack., biological subst.UN3373 +pouch

https://unicat.msf.org/cat/product/17534
STD STSSUN62DSI

Valid Article

Former Code(s): PPACUN62DSI PPACUN62BIT STSSDSI
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.
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, biological subsance 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.

Isotherm box, allowing to keep the samples between 2ºC and 8ºC for 72 hours, with 4 icepacks, or below -20°C with dry ice.

Meets the packaging instructions 650 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
  • Hermetic seal (if necessary, fix the cap with sealing film) and to be labelled with a permanent marker

2. Secondary container

  • Soft pouch polyethylene, waterproof with adhesive closure, 20 x 30 cm (STSSUN62WB-) or plastic container 14.8 cm (h) X 13 cm (Ø) (STSSCONP130P)
  • 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
  • Designed to hold 4 icepacks 0.6 liter (RCW25)
  • Can be used with dry ice, a sticker IATA class 9 is supplied
  • 42.5 x 29.5 x 22.5 cm

Instructions for use

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

  • For diagnostic of tuberculosis (sputum in dry tube).
  • For the diagnostic of Measles/rubella (whole blood or serum)

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 substance (Category B) by cold chain with every means of transport.

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