ISO 7886-1

Annex B: Test method for air leakage past syringe plunger stopper duringaspiration, and for separation of plunger stopper and plunger
– Comprehensive Overview of Syringe Leak Test

Standard Summary

ISO 7886-1 is a critical international standard focused on the functional requirements and performance criteria for single-use syringes. Specifically, it applies to sterile hypodermic syringes intended for manual use, typically used for subcutaneous, intramuscular, or intravenous injections. As syringes are essential in medical treatments, ensuring their safety and reliability is paramount, and ISO 7886-1 provides comprehensive guidelines for evaluating these devices.

One performance requirement of syringe is the freedom from air and liquid leakage past plunger stopper. So among the many performance factors covered in ISO 7886-1, one of the most critical aspects is the syringe leak test. This test is designed to detect any potential leaks in the syringe body, plunger, or air past the plunger stopper or seals that could compromise the sterile barrier or cause inaccuracies in fluid delivery.

ISO 7886-1 Annex B Description

ISO 7886-1 Annex B outlines the test method for air leakage past syringe plunger stopper during aspiration, and for separation of plunber stopper and plunger, to ensure that single-use syringes meet strict quality requirements, which is one of the critical functional tests within this standard.

ISO 7886-1 Annex B Principle

The syringe nozzle is connected to a compatibl connection and the syringe partially filled with water. A negative pressure of 88KPa is applied through the nozzle, and the syringe inspected for leakage pass the plunger stopper and seal(s) and to determine if the plunger stopper becomes detached from the plunger.

Test Theory

The syringe leak test evaluates the integrity of the syringe by applying specific pressure conditions to detect any leaks or weaknesses. This test involves assessing the tightness of the plunger and the syringe barrel to prevent unintended fluid loss during medical procedures. If the syringe leaks under the specified pressure or during simulated use conditions, it would fail the test, as such failure would compromise the device’s sterility and performance, posing significant risks to patients.

Detailed Description of the Test Process

The leak test under ISO 7886-1 is a combination of air and fluid pressure testing that evaluates the primary body of the syringe plunger stopper and seal(s).

1. Draw into the syringe a volume of water of not less than 25% of the nominal capacity
2. Withdraw the plunger stopper axially until the fiducial line is at the nominal graduated capacityand clamp the plunger in this position.
3. Connect the syringe nozzle to the conical fitting and then generate the vacuum.
4. Adjust the vaccuum increase time so that a gradual reduction in pressure is obtained and a pressure reading of 88 kPa below ambient atmospheric pressure is reached.
5. Hold the vacuum level and observe the pressure reading for 60s and record any fall in the reading. Examine the syringe to determine if the plunger stopper is detached from the plunger.

Testing Equipment

Testing syringes for leaks requires specialized equipment that can apply precise pressure and detect even the smallest leaks. For manufacturers and laboratories seeking reliable, precise and high-throughput testing solutions, the Cell Instruments SLT-02 and SLT-03 Syringe Leak Tester are leading examples of such equipment, offering automated leak detection capabilities for high-throughput testing.

Automated precision: Accurate pressure application and leak detection ensure compliance with regulatory standards.
User-friendly interface: Intuitive controls make it easy for operators to set up and conduct tests efficiently.
High versatility: Holding fixture is compatible with a wide range of syringe sizes, from small-volume syringes to large-capacity medical syringes.

Key Features

Precise pressure control

Adjustable pressure levels to simulate real-use conditions accurately.

Automated testing process

Streamlined and repeatable testing for compliance with ISO 7886-1.

Compatibility

Suitable for a variety of syringe sizes, ensuring full flexibility in testing.

Result Expression

The results of the syringe leak test are typically expressed in terms of pressure drop (in case of an air leak test) or whether the plunger stopper detached from the plunger. The outcome of the test is classified as either pass or fail based on the criteria set forth by ISO 7886-1.

Pass: No leakage is observed, and the syringe maintains integrity under specified pressure.
Fail: Leakage is detected, either through visible signs (air bubbles, plunger stopper detached from the plunger) or through a pressure drop.

Significance of ISO 7886-1

The syringe leak test ensures that syringes maintain their functionality and sterility during use, preventing unintended exposure to pathogens or medication dosing errors.
The ISO 7886-1 standard plays a crucial role in ensuring the safety and efficacy of medical syringes. Syringes are among the most widely used medical devices, and any failure in their integrity can result in dire consequences, including:

Inaccurate drug delivery

Leaks in a syringe can lead to the delivery of incorrect drug doses, potentially resulting in under-treatment or adverse effects due to overdose.

Sterility breaches

Any leakage in a syringe compromises its sterile barrier, leading to the risk of contamination and infection for the patient.

Patient safety

Ensuring that syringes meet the stringent requirements of ISO 7886-1 protects patients from adverse outcomes, making this test a vital component of medical device quality control.

FAQ about ISO 7886-1

What is the primary objective of ISO 7886-1 testing?

The IS0 7886 series covers hypodermic syringes primarily intended for human use and provides performance and testing requirements.

Why is air pressure used for leak testing in ISO 7886-1?

Air pressure allows for precise detection of small leaks that might not be visible in fluid testing. Additionally, air testing is often more sensitive and faster.

Is the ISO 7886-1 test destructive?

No, the leak test is non-destructive, meaning that the syringe can be tested without causing any damage or compromising its functionality.

Which syringe types are subject to ISO 7886-1?

ISO 7886-1 specifies requirements and test methods for verifying the design of empty sterile single use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users, ISO 7886-1 does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in ISO 7886-1 are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
ISO 7886-1 also excludes syringes for use with insulin (see IS0 8537), single-use syringes made of glass, syringes foruse with power-driven syringe pumps, syringes prefilled by the manufacturer, and syringes intended to be stored after filling. Hypodermic syringes without a needle specified in this standard are intended for use with hypodermic needles specified in ISO 7864.

Can the leak test detect both air and fluid leaks?

Yes, the syringe leak test can be conducted with air or liquid to detect any leaks in the body or connections of the syringe.

What are the consequences of failing the syringe leak test?

Syringes that fail the leak test are considered unsuitable for use due to the risk of contamination, inaccurate dosing, or other medical complications.

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