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SHEET, STERILIZATION, non-woven, 1.2 x 1.2 m

https://unicat.msf.org/intros#21935
https://unicat.msf.org/cat/product/13789
STD ESTEPAPN12-

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.
S010302 - Non-woven fabric 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
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, NON-WOVEN

Definition

Sheet of paper used to 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 sheets 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
  • EN 868-9, 2019, Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - 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

  • Non-woven: blend of cellulose fibres and synthetic fibres (100% synthetic for certain models)
  • Good permeability to steam
  • Good microbiological barrier
  • Good permeability to air
  • Very good flexibility and drapeability
  • Meets the requirements of the EN 868:1-2 standard as regards grammage, porosity, water repellency time, tensile strength, drapeability
  • Dimensions (may vary from one supplier to another): +/- 1.2 x 1.2 m
  • Single use, non sterile

Instructions for use

See sterilization protocols

(Cf Introduction: Disinfection and sterilization in the field)

To be reserved for large and heavy packages like orthopaedic surgical boxes since it is more resistant and more flexible than crepe paper.

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Storage

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

MSF requirements

Sheets made of non-woven paper are larger and more resistant, and reserved for very large and heavy surgical sets as the external fixator box.

For other indications use the crepe paper, which is cheaper (see related articles below).

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