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DRAPE, non-woven, high perf., sterile, orthopaedic set

https://unicat.msf.org/intros#21930
https://unicat.msf.org/cat/product/13546
STD ELINDRSS3OR

Valid Article

Former Code(s): -X
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.
T020102 - Specialistic surgery 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 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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STERILE DRAPES, non-woven

Definition

A sterile protective covering, or a collection of various different types of sterile drapes, covers and/or towels, made of synthetic materials and designed to isolate a site of surgical incision or a surgical field from contamination in various clinical settings (e.g., in an operating room).

Specifications

  • Non-woven (polyethylene, polypropylene, etc.)
  • Composed of one absorbent layer and one impervious layer
  • Tear resistant
  • Flexible
  • Sterile, for single use
  • Optional: adhesive drape or additional adhesive tape for fixation

Quality standards

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

Quality Standards Comment

EN 13795 test results (drape high performance)

  • EN 29073-3: Tensile strength - dry and wet: ≥ 20 Newton (amount in force applied to break the strip)
  • EN 13938-1: Burst strength - dry and wet: ≥ 40 kPa strength at burst
  • EN 20811: Resistance to fluid penetration: critical area / less critical area: ≥ 100/10 cm of water pressure on the fabric sample
  • EN ISO 11737: Cleanliness – microbial: ≤ 300 Number of colonies formed / dm²
  • ISO 9073 -10: Cleanliness - particulate matter and Linting: Number of particles 3-25µm as an index for PM expressed as Log10: critical area / less critical area: ≤ 3.5 / ≤ 4.0
  • ISO 22612: Resistance to microbial penetration – dry: ≤ 300 CFU (number of colonies formed after incubation)
  • ISO 22610: Resistance to microbial penetration – wet: for the critical area: ≥ 6.0 Number of colonies formed after incubation, expressed in Barrier Index

Technical specifications

  • single drape for nursing care: ± 45 x 75 cm
  • Caesarean section set
    • table drape: ± 200 x 150 cm
    • drape: ± 300 x 250 cm
    • baby cover: ± 100 x 80 cm
    • absorbent towels
  • orthopaedic set
    • table drape: ± 200 x 150 cm
    • drape with window: ± 300 x 225 cm
    • absorbent towels
  • universal set
    • table drape: ± 200 x 150 cm
    • 2 lateral drapes: ± 100 x 75 cm
    • surgical drape: ± 180 x 150 cm
    • surgical drape: ± 250 x 150 cm
    • absorbent towels
  • Mayo cover: rectangular bag of ± 145 x 80 cm

Packaging & Labelling

  • Single drapes: unit sterile packaging in peel-open pack
  • Sets: double sterile packaging in peel-open pack

Instructions for use

Disposable drapes are intended for situations where sterilization is problematic. It is recommended to keep a small emergency stock in every hospital.

Single use linen is MSF standard for orthopedic surgical procedures.

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