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COMPRESS, NON WOVEN, 4 plies, 10 cm, sterile

https://unicat.msf.org/intros#21930
https://unicat.msf.org/cat/product/64984
STD SDRECOMN10S

Valid Article

Former Code(s): -X SDRECOMN+++
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.
M0202010101 - Non-woven folded gauzes, without x-ray detectable thread, sterile
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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COMPRESS, NON-WOVEN, sterile

Definition

A non-medicated, sterile compress made from non-woven material and primarily designed to absorb fluids for medical purposes.

It is used to cover/clean wounds and absorb their exudates, to apply topical medications or disinfect healthy skin prior to a venipuncture or an injection.

It produces less lint, is less adherent and less abrasive compared to basic woven gauze pads.

Specifications

Quality standards

  • 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

  • Synthetic material:
    • viscose: 67% (± 3 %)
    • polyester: 33% (± 3%)
    • latex-free
  • Weight: ± 40 g / m² +/- 10%
  • Size folded: 10 x 10 cm
  • Absorbency: ± 11 g of water
  • Thickness: 4 plies
  • Radio transparent
  • Sterile, for single use

Packaging & Labelling

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.

Each pouch contains 5 compresses

In dispenser box of 25 to 50 sachets

(Cf Introduction: Packaging and labelling)

Instructions for use

Sterile dressings are used for cleaning and covering of wounds, absorption of exudates and wound dressings.

These compresses do not replace the gauze compresses which have two different indications.

  • In wound care gauze compresses are used only for cleansing of wounds when devitalized tissues (necrosis - fibrin) or dirty / external material has to be removed.
  • Gauzes have a more effective scratching effect which create superficial debridement of devitalized tissues.

It is better to use sterile compresses rather than non sterile compresses that are sterilized in the field. This is important for quality, hygiene, time and cost reasons.

MSF requirements

Non-woven compresses have less risk of sticking on the wound bed compared to gauze compresses, reducing the trauma on the healing tissues during the change of dressing. An additional unintended advantage is that non-woven compresses are cheaper than gauze compresses.

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