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PROCEDURE MASK, type IIR, earloops, s.u.

https://unicat.msf.org/cat/product/80290
STD ELINMASS5--

Valid Article

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.
T020604 - Medical use face masks, type ii and iir
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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MEDICAL FACE MASK type IIR

Definition

Medical device covering the nose, mouth and chin, designed to limit transmission of infectious agents exhaled by the nose and mouth of the wearer, and additionally to protect the wearer against liquid splashes.

According the intended use, MSF distinguishes two kinds:

  • SURGICAL MASK: the face mask to be used by the medical staff in the operation theatre are attached with straps
  • PROCEDURE MASK: face mask with earloops, used by medical staff outside the operation theatre

Specifications

Quality standards

  • EN 14683, 2019, Medical face masks - Requirements and test methods
  • ISO 22609, 2004, edition 1, (confirmed 2020) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

Technical specifications

  • Non-woven
  • Shape providing completely coverage of the nose, mouth and chin (e.g. rectangular shape comprising 3 or 4 folded layers)
  • Malleable nose strip, made of aluminium, allowing a snug fit
  • Internal and external surfaces are clearly identified
  • Attachment with 2 pairs of ties for ELINMASS3-- and ELINMASS4FS, with earloops for ELINMASS5--
  • Latex-free, glass fibre-free
  • Meets the requirements of type IIR (corresponding to ASTM level 2)
    • bacterial filtration efficiency (BFE) > or = 98%
    • differential pressure (breathability) < 60 Pa
    • splash resistance pressure > or = 120 mm Hg
  • Non sterile, for single use
  • Indicative dimensions:
    • mask: flat: 90 x 175 mm / unfolded: 175 x 175 mm
    • nose strip: +/- 12 - 13 cm or 2/3 of the width of the mask
    • ties / straps: +/- 40 cm
  • Shield for ELINMASS4FS
    • Impermeable to liquids
    • Antistatic, anti-fog and optically clear shield
    • Flexible
    • Panoramic: covering upper part of the face and lateral sides

Packaging & Labelling

Distribution box of 50 to 100 masks

Labelling

  • Name and address of the manufacturer
  • When the legal manufacturer is not established in the EU, the name and postal address of the authorized representative is mentioned
  • Batch number/Lot number
  • Expiry date, expressed at least as the year and month
  • Qty / pack
  • The device is intended for single use only
  • CE marking: As procedure masks are Class I medical devices, the CE mark does not show a 4-digit NB number.

For EU standard

  • Reference to the standard: EN 14683
  • Classification: Type IIR
  • MD Class I = CE marking without mentionning a NB (4-digit number)
  • Name and address of the manufacturer (or the authorized representative in case the manufacturer is not established in the EU)
  • Batch number / lot number
  • Expiry date, expressed at least as the year and month
  • Device is intended for single use

For US standard / FDA cleared: The ASTM F2100-11 standard requires a graphic display on the packaging stating the mask performance level: ASTM Level 2 (moderate barrier) corresponds to the Type IIR (ASTM Level 3 has the same bacterial filtration rate but a higher fluid resistance, corresponds also to a Type IIR)

Instructions for use

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MSF requirements

The medical face mask is one of the basic items needed in every hospital project.

Type IIR is the best option, and the only type of face masks to be used in the OT. The model with straps to attach the mask allow a better fit.

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