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SYRINGE, s.u., NRFit Lock, 5 ml

https://unicat.msf.org/cat/product/80094
STD SINSSYNRL05

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.
A020199 - Syringes, single-use - other
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, NRFit Lock

Definition

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications: to administer medications to neuraxial sites and other regional anaesthesia procedures. At the distal end of the barrel is a male connector NRFit intended to avoid connection errors to Luer devices. This is a single-use device.

Specifications

Image

Quality standards

  • ISO 80369-1, 2018, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
  • ISO 7886-1, 2017, edition 2, (confirmed 2022) Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
  • ISO 80369-6, 2016, edition 1, Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications

Quality Standards Comment

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.

Technical specifications

  • BARREL: the reservoir for holding the liquid
    • transparent polypropylene / polyisoprene
    • capacity: 3 ml , 5 ml and 10 ml
    • scale markings are etched or printed on the barrel: in millilitres, easily readable
    • graduations:
    • every 0.1 ml (3 ml syringe)
    • every 0.2 ml (5 & 10 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 NRFit tip (20% smaller compared to Luer): 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.
    • Yellow color coding (not ISO defined) for fast identification of NRFit devices
  • Sterile, for single use

MSF requirements

part of the NRFit rachi anesthesia set

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