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AUTO-DISABLE SYRINGE, with needle, s.u., BCG imm., 0.05 ml

https://unicat.msf.org/cat/product/18706
STD SINSSYAI05B

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.
A02010205 - Infusion and irrigation syringes with safety system, 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.
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
CT3+
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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SYRINGE, AUTO-DISABLE with needle

Definition

Auto-disable syringes with a metal clip that locks the plunger after a single use. The syringe has a fixed needle and is packaged with plastic caps to keep the needle and plunger sterile before use.

It is used for fixed-dose immunization.

Synonym

AD syringe

Specifications

​WHO/PQS/E08-E13

Quality standards

  • ISO 7886-3, 2020, edition 2, Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization
  • ISO 7864, 2016, edition 4, (confirmed 2021) Sterile hypodermic needles for single use - Requirements and test methods
  • ISO 7886-1, 2017, edition 2, (confirmed 2022) Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

Quality Standards Comment

WHO/PQS/E08E13/GUIDE.1.4: Pre-qualification of single-use injection devices under the PQS system: Guidelines for manufacturers

Technical specifications

  • BARREL
    • transparent polypropylene
    • capacity:
      • SINSSYAI005 => 0.5 ml (+ 20 % max)
      • SINSSYAI05B => 0.05 ml (+ 20 % max)
    • graduations: only 0 and capacity of the syringe
    • dead space:
      • 0.5 ml syringe => = 0.07 ml
      • 0.05 ml syringe => = 0.025 ml
  • PLUNGER
    • polypropylene, polyethylene
    • perfectly fit to slide easily and smoothly inside the barrel
  • GASKET
    • synthetic elastomer (latex free)
    • ensures an efficient seal
  • NEEDLE
    • stainless steel
    • integrated on the syringe
    • with protective sheath
    • 0.5 ml syringe: 23G x 25 - 30 mm
    • 0.05 ml syringe: 27G x +/- 10 mm
  • AUTO-DISABLE SYSTEM
    • automatically activates upon administration of the intended fixed dose
    • prevents re-use of the syringe and the needle
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

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Precautions for Use

Change in injection technique required: Because the plunger can go back and forward only once, one should NOT draw up air to inject it into the vial. In addition, the locking mechanism decreases the distance that the plunger can move if you aspirate for blood when giving an injection. It is still possible to aspirate, but the plunger will travel only a short distance.

To prevent accidental needlestick injuries, never recap the needle after use.

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