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SYRINGE, Luer-lock, 10 ml, s.u.

https://unicat.msf.org/cat/product/45175
STD SINSSYLL10-

Valid Article

Former Code(s): SINSZFR0053
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.
A02010202 - Infusion and irrigation syringes, luer lock cone, single-use
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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SYRINGE, Luer-lock

Definition

A sterile device consisting of a calibrated barrel with plunger intended to be used for injection/withdrawal of fluids (e.g., medication) to/from a medical device or the body. At the distal end of the barrel is a male Luer connector for the attachment of the female connector (hub) of a hypodermic needle or an administration set.

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Specifications

  • A Luer-lock syringe allows a needle to be twisted onto the tip and then locked in place. The needle and the syringe are twisted together and the screw thread prevents the Luer Slip connector from coming off.
  • Luer-lock syringes are advised for application when back pressures are higher and where leakage avoidance is essential.

Benefits

  • Provides a more secure connection due to the screw thread design which holds the needle in place more effectively
  • Prevents the accidental removal of the needle during the injection of fluids making them much more reliable
  • Greatly reduces the chance of leakage by forming a more permanent seal
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Quality standards

  • ISO 7886-1, 2017, edition 2, (confirmed 2022) Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
  • ISO 7886-2, 2020, edition 2, Sterile hypodermic syringes for single use – Part 2: Syringes for use with power-driven syringe pumps

Technical specifications

  • BARREL: the reservoir for holding the liquid
    • transparent polypropylene / polyisoprene
    • capacity: 1 ml, 3 ml, 5 ml, 10 ml, 20 ml and 50 ml (30ml as NST)
    • scale markings are etched or printed on the barrel: in millilitres, easily readable
    • graduations: every 0.01 ml (1 ml syringe), every 0.1 ml (3 ml syringe), every 0.2 ml (5 ml syringe), every 0.5 ml (10 ml syringe) or every 1 ml (20 and 50 ml syringe)
    • with flanges: "wings" that jut out from the side of the syringe barrel. they provide an area or surface for the index finger and the middle finger to grasp during aspiration or administration.
    • with retaining ring (plunger backstop) to prevent accidental plunger rod withdrawal
    • ending with a centered male Luer tip: lock or screw-on connection for a needle
  • PLUNGER: a piston-like device inside the barrel, designed for single-handed operation
    • polypropylene, polyethylene
    • perfectly fit to slide easily and smoothly inside the barrel
    • with thumb press: an area where one presses to push the plunger rod down into the barrel to expel contents.
    • plunger tip: the three part syringes end in a synthetic elastomer plunger tip or gasket, flat or dome shaped. This tip assures a perfect plunger barrel seal integrity and a flawless gliding behaviour. The gasket may be double-contact.
  • Sterile, for single use

Note: the 1 ml and 50 ml syringes are mostly 3-part syringes (including a gasket), the 2 / 3 ml, 5 ml, 10 ml and 20 ml syringes are also available as two-part syringes (without gasket). The barrel material of these two-part syringes often contains a lubricant allowing a smooth advancement of the plunger without the need of a rubber ring.

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

The syringe is strictly single use: do not reuse, even not for the same medication / patient.

This syringe can be used with the syringe pump (see related articles below) and is compatible with the different models of pumps.

Precautions for Use

Luer-Lock syringes may also be used with a syringe driver.

The pump needs to know certain characteristics (e. g. diameter & length of cylinder, length of plunger) to ensure the proper function and accurate infusion. The user manual of the syringe driver shows a list with compatible syringes from different manufacturers. All these syringes have been tested and approved by the manufacturer of the syringe driver. (providing no changes on the characteristics of the syringes)

MSF requirements

  • the 20 & 50 ml are for use with the syringe pump
  • the small syringes Luer-lock are needed for specific procedures: use with IO needles, rachi needles, MAD device
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