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WATER for irrigation, 1 l, pl. bottle, sterile

https://unicat.msf.org/cat/product/76897
STD SSCOWATE1B1

Valid Article

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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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WATER for irrigation

Definition

A fluid consisting of sterile water (no other compounds/additives) intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation and humidification). It is typically provided in an appropriate container.

Specifications

Technical specifications

  • composed entirely of sterile water for injection USP
  • pH = 5.7 (5.0 - 7.0)
  • no bacteriostatic, antimicrobial agent or added buffer
  • sterile solution, for single use
  • semi-rigid bottle with screw cap
  • volume: 1000ml

Packaging & Labelling

The plastic bottle is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The bottle is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration.

Instructions for use

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Precautions for Use

  • Sterile water for irrigation is hypotonic and will cause hemolysis, it is not recommended for use during surgical procedures.
  • Aseptic technique is essential with the use of sterile solutions for irrigation
  • Not for injection by usual parenteral routes.
  • Do not warm above 66°C.
  • After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
  • Discard unused portion of irrigating solution since it contains no preservatives.

Storage

Read the manufacturer's instructions on the packaging.

  • Exposure of pharmaceutical products to heat should be minimised. Avoid excessive heat.
  • Protect from freezing.
  • It is recommended that the product be stored at room temperature (between 15 and 25°C); however, brief exposure up to 40°C does not adversely affect the product.

MSF requirements

  • Sterile water to fill the humidifiers of infant incubators,CPAP machines and oxygen concentrators.
  • It can also be used to fill the Thoracic drainage bottle (EMEQDBOT2--), as the whole system must be sterile.
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