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ABSORBENT DRESSING, medium, sterile, s.u.

https://unicat.msf.org/cat/product/35741
STD SDREABSD1M-

Valid Article

Former Code(s): SDREZNL0065 SDREDRWN1020 SDREABSD1020
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
M040204 - Non-adherent absorbent dressings
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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ABSORBENT DRESSING

Definition

A sterile wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent.

Specifications

Dressing consists of 3 layers

  • Non-woven or non-adherent layer: in contact with the wound (reduced risk of adhesion to wound).
  • Pad with absorbent fibres: cotton wool, cellulose or viscose, with an integrated distribution layer for even distribution of wound exudate
  • Hydrophobic backing: to prevent strike through, in a distinguished colour or marking to avoid confusions with the wound-contact layer.

Quality standards

  • EN 13726-1, 2002, Test methods for primary wound dressings - Part 1: Aspects of absorbency
  • EN 1644-1, 1997, Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
  • EN 1644-2, 2000, Test methods for nonwoven compresses for medical use Part 2: Finished compresses

Technical specifications

  • hypoallergenic
  • breathable
  • passive dressing: does not contain any active substances
  • free swell absorptive capacity of the dressing: 50 g liquid/100 cm² or 10-15 g liquid/g dressing
  • sterile, for single use
  • dimensions:
    • small: 10 x 10 cm, 15 x 15 cm
    • medium: 10 x 20 cm, 15 x 20 cm, 15 x 25cm
    • large: 20 x 20 cm, 20 x 25 cm
    • exact dimensions vary according to manufacturer

Packaging & Labelling

Each single compress is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage of all pouched items until needed for use and facilitating proper aseptic presentation of the material.

(Cf Introduction: Packaging and labelling)

Instructions for use

Precautions for Use

  • Fixation is necessary.
  • Cannot be cut.
  • Should not be used during surgical interventions: use abdominal compresses instead.

MSF requirements

Absorbent sterile dressing that is able to absorb the exudate in moderately to highly exuding wounds.

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