The Safety Syringe with Integrated Needle 1ml combines an ultra-low dead space fixed needle with a permanently locking protective shield to reduce medication waste and eliminate occupational needlestick injuries. Built with a clear polypropylene barrel and chemical-resistant graduation markings, this precision instrument delivers exact micro-dosing for vaccines, insulin, and specialized clinical therapies. Compliance documentation, sterilization batch validation, and bulk volume quotations are provided for qualified healthcare distributors, medical importers, and institutional tender buyers.

Key Features

Integrated Fixed Needle Structure: Eliminates the hub junction to remove fluid entrapment zones and prevent needle detachment under injection force.

Single-Handed Safety Shield: Locks permanently over the contaminated cannula immediately post-injection with an audible engagement click.

Ultra-Low Dead Space Performance: Sustains residual fluid volume below 0.005 mL, enabling complete dose extraction from multi-dose vials.

Automated Siliconized Needle Point: Utilizes triple-bevel grinding and silicone lubrication to minimize tissue resistance and penetration force.

High-Contrast Transparency Barrel: Displays accurate volumetric scaling in smudge-proof ink for precise air bubble detection and fluid measurement.

Latex-Free Synthetic Elastomer Stopper: Provides smooth, uniform plunger travel with low break-force resistance across varying injection speeds.

Technical Specifications

Parameter	Specification	Compliance Standard
Product Name	Safety Syringe with Integrated Needle 1ml	ISO 7886-1
Nominal Volume	1 mL	ISO 7886-1
Graduation Interval	0.01 mL / 100 Units	ISO 7886-1
Dead Space Volume	≤ 0.005 mL	ISO 7886-1
Needle Gauges	25G, 27G, 29G, 30G	ISO 9626
Needle Lengths	13 mm (1/2 in), 16 mm (5/8 in)	ISO 9626
Barrel Material	Medical-grade Polypropylene	USP Class VI
Stopper Material	Isoprene Synthetic Rubber	ISO 10993
Safety Lock Type	Hinged shield with dual locking tabs	ISO 23908
Sterilization Method	Ethylene Oxide (EO)	ISO 11135
Sterility Assurance	SAL 10^-6	ISO 11135
Shelf Life	5 Years	ISO 11607

Design and Construction

Barrel and Plunger Assembly
Molded from medical-grade polypropylene, the transparent barrel features high-contrast graduation lines resistant to alcohol rubbing. An internal retaining ring stops accidental plunger removal during liquid draw.

Integrated Needle Attachment
The stainless steel cannula is directly bonded into the barrel collar during molding. Removing the Luer connection eliminates residual hold-up volume and prevents fluid leakage under high pressure.

Safety Shield Mechanism
An attached protective shield folds over the cannula post-use. Applying thumb pressure or pushing the shield against a flat surface secures the needle inside a closed rigid housing.

Elastomeric Sealing System
A synthetic latex-free stopper forms a dual-ring seal against the inner wall, preventing fluid bypass during high-speed aspiration and maintaining low sliding force.

Intended Use and Applications

01/

Mass Vaccination Programs
Extracts maximum usable doses from multi-dose medication vials while protecting healthcare operators during high-volume administration.

02/

Subcutaneous Insulin Delivery
Ensures accurate unit dosing for daily diabetes management in clinical and home environments.

03/

Intradermal Allergy and Tuberculin Testing
Maintains exact 0.1 mL volumetric accuracy without fluid loss during shallow needle insertion.

04/

Pediatric Parenteral Care
Provides accurate micro-volume dosing control required for sensitive infant drug regimens.

Quality and Regulatory Information

Quality Management: Manufactured in facilities operating under ISO 13485 quality systems.

Biocompatibility Verification: Tested under ISO 10993 for cytotoxicity, systemic toxicity, hemocompatibility, and intracutaneous reactivity.

Sterility and Gas Residue Control: Batch released under EO gas residual limits below 4 ppm and bacterial endotoxin thresholds under 20 EU/device.

Automated Line Inspection: Evaluated via optical vision systems for cannula straightness, bevel integrity, print alignment, and shield closure force.

Packaging and Supply

Packaging Level	Configuration
Primary Pack	Individual blister pack (Medical-grade paper + thermoforming film)
Secondary Pack	100 units per inner shelf box
Master Packaging	1,800 units per double-wall corrugated shipping carton
Pallet Logistics	Heat-treated wooden or plastic pallets
Traceability Labeling	GS1 DataMatrix code, Lot number, production and expiration dates

Customization Options

Cannula Dimensions: Specific needle gauge and length combinations tailored to drug viscosity requirements.

Volumetric Scales: Alternate increment printing, dual unit markings, or specialized scaling.

Blister Print Specifications: Private label artwork, multilingual clinical instructions, and local registration numbers on primary backing paper.

Carton Quantities: Flexible inner box counts and transport dimensions optimized for shipping container space.

FAQ

Q: What distinguishes an integrated needle safety syringe from a detachable needle safety syringe?

A: An integrated needle syringe secures the cannula directly into the barrel body. This eliminates the junction gap found in Luer connections, reducing dead space volume and eliminating needle detachment risks.

Q: How is the safety mechanism locked after injection?

A: The protective shield is pressed forward over the exposed cannula using a single-handed thumb motion or by pushing it against a flat surface until two locking tabs click permanently into place.

Q: What is the measured dead space volume for this product?

A: The fixed needle construction maintains a residual fluid volume below 0.005 mL, meeting international standards for dose-sparing clinical protocols.

Q: What compliance documents accompany wholesale shipments?

A: Every shipment includes a Certificate of Analysis detailing Ethylene Oxide sterilization parameters, bioburden testing, and residual gas analysis.

Q: Can customized needle sizes be requested for production orders?

A: Custom combinations of cannula gauge diameter and length can be produced based on minimum order quantity agreements.

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