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SHEET, STERILIZATION, crepe paper, 0.9 x 0.9 m

https://unicat.msf.org/intros#21935
https://unicat.msf.org/cat/product/13792
STD ESTEPAPS09-

Valid Article

Former Code(s): -X
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.
S010301 - Medical crepe paper for sterilisation
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
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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SHEET, STERILIZATION, CREPE PAPER

Definition

Sheet of crepe paper used to pack / wrap medical devices to be sterilized by steam autoclave and maintained sterile until they are used.

Paper of which porosity allows penetration by steam, but not by micro-organisms after autoclaving.

Synonym

sterilization paper

Specifications

Allows to maintain sterility after autoclaving for maximum 15 DAYS in the MSF missions provided two layers of non-woven paper are used and the storage conditions are good (protected from any risk of puncture, dust and humidity)

Quality standards

  • EN 868-2, 2017, Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
  • ISO 11607-1, 2019, edition 2, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

Technical specifications

  • Made of cellulose fibres
  • Good permeability to steam
  • Good microbiological barrier
  • Low permeability to air
  • Meets the requirements of the EN 868-2 standard:
    • Grammage: 58 - 62 g/m2
    • Porosity: 50 µm maximum
    • Water repellency time: minimum 20 seconds
    • Tensile strength and drapeability
  • Single use, non sterile
  • Selection of 3 different sizes enabling small, medium and large packages.
    • ESTEPAPS07- = +/- 0.75 x 0.75 m
    • ESTEPAPS09- = +/- 0.9 x 0.9 m
    • ESTEPAPS1-- = +/- 1.2 X 1.2 m
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Storage

In a clean and protected area, protected from risks of puncture, dust and humidity.

MSF requirements

Crepe paper sheets were selected for their good price/efficiency ratio. Sheets made of non-woven paper, larger and more resistant, are also available for very large surgical sets (see related articles below).

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