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General Characteristics Single-use Sterile Including a mechanism to prevent reuse The syringe and needle shall be passively and automatically rendered unusable by the delivery of the intended fixed dose. And/ Or The auto-disable feature is automatically activated and remains effective from the time that the injection is commenced. And / Or The auto-disable feature is automatically activated on completion of the delivery of the intended fixed dose. Type and application Non-pre-filled, disposable. To administer DTP, DT, tetanus toxoid and diluted freeze dried measles etc for intramuscular and sub-cutaneous injection. Syringes with permanently attached needle Material Polypropylene with or without stainless steel Syringe size with pre-set volume and single marking 0.5ml for immunization (+20% to allow for removal of air) Graduation and accuracy Two markings only: 0 and 0.5ml. The difference between the maximum graduated volume and the expelled volume of distilled water shall not be greater than �± 25 micro-liters. Needle for Immunization · Diameter : 23G Length : 25mm (1) Stainless steel needle tubing for the manufacture of medical devices Needle shall confirm to IS 10654 of 2002 (third revision) equivalent ISO 7864 of 1993 Needle fixing Fixed capped, needle (23 G X 25 mm). Fixed needles should withstand an axial pulling force of 34N without separating from the syringe. If accidental needle stick protection devices are included in the design of the syringes or needle, they should not compromise the ease of use or the performance of the syringe. Leakage : Leakage of distilled water at a pressure of 0.3 mPa (3 atmospheres) for six minutes shall not be greater that 50 micro-liters. Dead space The maximum dead-space shall be 50 micro-liters. Self destruction The syringe shall be automatically rendered unusable when it has delivered a 0.5 ml dose of vaccine or distilled water. Filling The syringe is filled by inserting the needle through the septum of a sealed vaccine vial.
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