ISO 7886-1 Sterile Hypodermic Syringe Test - Leakage & Glide

ISO 7886-1

Sterile Hypodermic Syringe Test

ISO 7886-1: Sterile hypodermic syringes for single use – Part 1: Syringes for manual use defines the international standard for the design, performance, and testing of disposable syringes used for medical and pharmaceutical applications. It ensures syringes meet critical quality and safety requirements such as leak tightness, plunger operation, and mechanical integrity.

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Understanding ISO 7886-1

The ISO 7886-1 standard specifies the design, performance, and testing criteria for single-use syringes used in medical and laboratory applications. It ensures that syringes maintain integrity under mechanical, pressure, and leakage conditions.

Detecting Leaks in Syringes - Air & Liquid Leakage Test

Leak detection is one of the most crucial tests specified under Annex B and D of ISO 7886-1. It determines whether air or liquid leaks occur past the plunger stopper or barrel under specific pressure conditions.

Annex B - Air Leakage Test

Air leakage test (Annex B) requires the syringe to be partially filled with water and subjected to a vacuum of 88 kPa below ambient pressure. Any visible air bubbles or pressure drop indicates leakage or poor sealing. Cell Instruments SLT-02 Syringe Leak Tester perfectly simulates this process, allowing operators to apply controlled vacuum pressure and monitor leakage accurately.

Annex D - Liquid Leakage Test

Liquid leakage testing (Annex D) assesses the syringe’s sealing integrity when compressed internally. Using devices like Cell Instruments SPPT-01 Syringe Positive Pressure Tester, the syringe is filled, sealed, and pressurized up to 300 kPa, replicating real-use conditions. Observations of water seepage identify potential manufacturing defects.

Annex E
—— Syringe Glide Force Testing and Break Loose Force Testing

Smooth operation of the syringe plunger is vital for precise medication delivery and patient comfort. Annex E of ISO 7886-1 defines procedures for measuring the forces required to operate the plunger—including break loose force (initial movement) and glide force (steady motion).

Using a mechanical testing machine, the plunger is moved at a controlled speed of 100 ± 5 mm/min, while force values are continuously recorded. Excessive or inconsistent force may indicate poor lubrication, material incompatibility, or barrel deformation.

The Cell Instruments SSR-01 Syringe Glide Force Tester enables accurate determination of:

  • Break loose force (fs): Force needed to start plunger movement
  • Sustained glide force (F): Average force during plunger travel
  • Maximum glide force (Fmax): Peak resistance force observed

This data ensures that syringes provide consistent performance and meet ergonomic requirements defined in ISO 7886-1.

Hypodermic Syringe Testing and Needle Compatibility

Beyond syringe barrel and plunger evaluation, ISO 7886-1 works in conjunction with ISO 7864, which governs sterile hypodermic needles for single use. Proper connection between syringe and needle is verified using conical fittings compliant with ISO 80369-7. Compatibility testing ensures a secure fit, preventing leakage during fluid transfer. This aspect is vital in hypodermic syringe testing where precision injection is mandatory in medical and pharmaceutical industries.

Syringe Testing Equipment from Cell Instruments

Cell Instruments Co., Ltd. provides comprehensive syringe testing solutions fully aligned with ISO 7886-1 requirements:

Each instrument is designed with advanced automation and digital data acquisition capabilities, ensuring accurate, repeatable results while simplifying quality control workflows. Custom testing automation and data logging features make these devices suitable for medical device manufacturers, laboratories, and quality assurance departments.

ISO 7886-1 Sterile Hypodermic Syringe Test - Leakage & Glide 01

Contact Us Get ISO 7886-1 Testing Solution

Compliance with ISO 7886-1 is essential for manufacturers aiming to produce safe, effective, and reliable sterile hypodermic syringes. By integrating standardized testing methods—such as detecting leaks in syringes, syringe glide force testing, and break loose glide force testing—quality assurance teams can verify product integrity and performance consistency.

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