Syringe,insulin,1ml,U-100,30-31G/BOX-100

General Description:
Insulin Syringe, 1ml, U-100, three pieces: barrel with nozzle, stopper and piston/plunger with stainless steel fine needle and a needle orange cap.

Intended use: Solely for the subcutaneous single-use injection of insulin only in humans, with which the syringes are filled by the end user and used immediately after filling. Syringes are not intended to contain insulin for extended periods of time

Technical specifications:
Syringe nominal capacity (ml): 1ml

Syringe Unit scale (Units): U-100

Insulin Syringe type: Type 7 as per ISO8537:2016: Syringe with fixed needle tube and packaged in a unit packaging

Syringe graduation lines and numbering of scale: Graduated scale on the barrel, easy to read as per ISO8537:2016 where:
· The graduation lines of a uniform thickness between 0,2 mm and 0,4 mm and lie in planes at right angles to the axis of the barrel.
· The graduation lines evenly spaced along the longitudinal axis between the zero line and the line that marks the total graduated capacity.
· The length of the short graduation lines is approximately half the length of the long graduation lines.
· The scale and scale numbers should be legible and of a color that contrasts clearly with the syringe
· Scale graduated in increments corresponding to U-100, where scale intervals of 1 or 2 Units.
· Graduation lines numbered at every 10 units where the height of the numbers should be at least 3 mm.
· When the syringe is held vertically with the zero line uppermost and with the scale to the front, the numbers appear upright on the scale and centered on the graduation lines to which they relate.
· The numbers close to, but do not touch, the ends of the graduation lines to which they relate.

Syringe Barrel: sufficiently clear to enable dosages to be read and for air bubbles to be seen without difficulty. Barrel length with a usable capacity of either 10 % more than the
nominal capacity or 3 mm of plunger travel beyond the scale marking, whichever is less. Special marks on the barrel:
a) the text: “U-100 insulin”
c) the word: “units” or “I.U.”;
d) the total graduated capacity of the syringe, in milliliters.

Barrel Nozzle: The nozzle situated centrally.

Syringe Material: medical grade plastic (Polyethylene (PE)/ polypropylene (PP)/ polystyrene (PS). The materials used for fabrication of syringes and needles (including lubricant) and packaging do not adversely affect the efficacy, safety and acceptability of insulin preparations

Needle material: Stainless steel tubing conform to ISO 9626 and needle point in accordance with ISO 7864.

Needle Measurements: External diameter expressed in Gauge and millimeters.
Length expressed in inch and millimeters.

Size selected: 30-31G x 15/64”-5/16” (0.25-0.30 x 6-8 mm)

Needle Protective cap: Medical grade plastic.

Needle Cap Color code: Intended for dedicated use with the specific insulin concentration (U-100) where:
· Color of the needle cap: Orange
· No additional colors, other than black and white, used on the syringe barrel.

Dead space: minimum to reduce waste not exceed 0.01ml.

Syringe with integrated needle: Disposable.

Sterile: By Ethylene oxide and compiles to ISO 11135:2019)

Standards:
Product and packaging conform to ISO 8537:2016, ISO 7864:2016, ISO 9626:2016, ISO 11135:2019.

Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485 requirements (or equivalent).

Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).

Packaging and labeling:
Over packing in water-resistant export cartons.
Primary packaging: Each syringe packed in an individual sterilized peel-pack made of paper and/or plastic.

Secondary packaging: Protective packaging - 1 carton of 100 insulin syringes.