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SURGICAL DRAPE, microfiber, standard perf., 1x1 m

https://unicat.msf.org/cat/product/89363
STD ELINDRAS1M-

Valid Article

T0201 - Surgical drapes
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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SURGICAL DRAPE, reusable, microfiber

Definition

​A non-sterile (sterilised before use) protective covering made of synthetic materials, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room). The device may also be used to cover instrument tables.

Specifications

Microfiber is defined as a staple fiber or filaments of linear density approximately 1 dtex or less, and above 0.3 dtex (Decitex = measuring unit for yarn; 1 gram per 10000 meters). Polyester and polyamide are the main source to produce microfibers.

Fabrics made of microfibers are generally lightweight, resist wrinkling, have a luxurious drape on the body, retain shape, and resist pilling. They are also relatively strong and durable in relation to other fabrics of similar weight, and they are more breathable and more comfortable to wear. Fabrics made of microfibers show lower heat conductance and therefore higher thermal insulation properties.

Quality standards

EN 13795-1, 2019, Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Technical specifications

  • Fabric: microfiber carbon fabric, antistatic, water-resistant, high breathability. Latex-free. Withstands boiling and sterilization by steam autoclave; resists to chlorine 0.1%
  • Barrier capacity (liquid and bacterial penetration): standard performance
  • 4 hemmed borders
  • 2 sizes: 1 x 1 m. and 1.5 x 1.5 m
  • Colour: blue or green
  • The linen has a washing-counting label (80 washes)
  • Non sterile, reusable

Instructions for use

Maintenance

Adapt procedure according the context and the temperature limits of the‌ manufacturer.

All drapes must be laundered prior to use.

Barrier fabrics should be laundered separate from other hospital linens to minimize lint accumulation from other products and maximize the economics of the lightweight polyester fabric

Recommended washing formula: Combination washer/extractors should be loaded at approximately 70-75% capacity to allow correct flow of water across surfaces of these fabrics.

  • Do not use softner.
  • Do not use a brush: as the fabric is water repellent liquids will not penetrate. The use of a brush will deteriorate the fabric faster!

During the washing process a chemical or thermal disinfection is necessary - chemical disinfection can be done by active oxygen releasing chemicals (e.g. peracetic acid) or 0,1% chlorine solution (keep in mind that chlorine could reduce the maximum lifetime of the surgical gowns and drapes)

Take care to have a sufficient rinsing to avoid damaging of the surgical drapes during the following drying and sterilization process as well as to avoid skin reaction due to a to high pH value or residual detergents on the drape.

MSF requirements

The microfiber reusable drapes replace the woven (cotton/polyester) ones as these becomes difficult to find with the needed quality certificates ad medical device.

The standard performance (barrier capacity of the fabric) is selected by the surgeons for usual interventions, if needed, the disposable (sterile) surgical drapes selected by MSF are high performance.

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