Syringe Sealing Positive Pressure Tester

The Syringe Sealing Positive Pressure Tester is a precision instrument designed to evaluate the tight-fitting performance of disposable syringes. It uses a combination of intelligent manipulator, force measurement system, and distance measurement mechanism to accurately detect potential leakage under positive and negative pressure conditions. The device ensures compliance with syringe sealing standards and supports quality control and R&D applications in medical device production.

Application

This tester is suitable for evaluating a wide range of medical devices with Luer-type and non-Luer connections, including:

(1) Disposable syringes of various capacities (1–200 mL) – testing piston and barrel sealing integrity.

(2) Infusion and injection systems – verifying leakage under positive and negative pressure conditions.

(3) Catheters – ensuring connection sealing under axial and lateral forces.

(4) Blood transfusion sets – testing reliability of sealing components under pressurized conditions.

(5) Production line quality control – confirming consistent tight-fitting performance across batches.

(6) Research and development – assessing new syringe and piston designs for leak prevention.

Standards

The tester complies with the following domestic and international standards:

(1) GB/T 15810-2001: Disposable sterile syringes (China)

(2) YY/T 0909-2013: Standard for disposable medical syringes (China)

(3) ISO 7886-1: Sterile hypodermic syringes for single use – Part 1: Syringes for manual use (International)

(4) ISO 7886-2: Sterile hypodermic syringes – Part 2: Syringes for use with injectors (International)

Features

(1) Intelligent manipulator with CPU, motherboard, LCD display, and keyboard control.

(2) Force measurement and distance monitoring for precise evaluation.

(3) Supports both positive and negative pressure tests.

(4) Adjustable lateral force, axial pressure, nominal capacity, and test time.

(5) Real-time monitoring and reporting, suitable for both laboratory and production environments.

(6) User-friendly interface for easy parameter setup and test execution.

Parameters

Parameter	Specification
Lateral force	0.25 – 3.00 N, error ≤ ±0.5%
Axial pressure	100 – 400 kPa, error ≤ ±2%
Nominal capacity	1 – 200 mL (optional)
Test time	0 – 9999 s, adjustable
Working temperature	5 – 40 ℃
Relative humidity	45 – 80%
Standards compliance	GB/T 15810-2001, YY/T 0909-2013, ISO 7886-1, ISO 7886-2

Accessories

(1) Intelligent manipulator – 1 set

(2) Force measurement mechanism – 1 set

(3) Distance measuring group – 1 set

(4) Printer – 1 set

(5) Operation manual – 1 set

(6) Power cable – 1 set

Test Procedures

(1) Fill the syringe with nominal water volume.

(2) Apply specified axial pressure and lateral force on the piston for 30 seconds; ensure no leakage between piston and barrel.

(3) Apply 88 kPa negative pressure for 60 ± 5 seconds; ensure no air leakage and the piston remains securely engaged with the plunger rod.

(4) Monitor the readings and record results for quality assessment.

(5) Adjust parameters as needed for different syringe sizes and capacities.

Maintenance Information

(1) Keep the device clean and free from water and dust contamination.

(2) Inspect manipulators and force sensors regularly for wear or damage.

(3) Calibrate pressure and force sensors periodically to maintain test accuracy.

(4) Store in a dry and stable environment.

(5) Follow electrical safety precautions during operation.

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