WATER for irrigation, 1 l, pl. bottle, sterile
STD
SSCOWATE1B1
Valid Article
Account code:
60210
HS Code:
300490
Last Updated on:
04/10/2024, 14:28:03
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).
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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