ISO 11040-4 Syringe Glide Force Test for Break Loose Force

Syringe glide force testing is a crucial quality control measure used to ensure that syringes operate smoothly and consistently during injection. This test measures the resistance that the plunger of a syringe experiences when it slides through the barrel, which is an important factor in evaluating syringe performance, lubrication quality, and user experience.

In this article, we will explore what the syringe glide force test is, its significance in ensuring syringe functionality, how it is conducted, and the relevant standards, particularly ISO 11040-4, that guide this testing process. Additionally, we will highlight the features of the MST-01 Syringe Tester, a tool that can be used to perform this test with high precision.

What Is the Syringe Glide Force Test?

The syringe glide force test measures the force required to move the plunger of a syringe through its barrel. This resistance can be caused by factors such as the quality of the lubrication inside the barrel or the characteristics of the plunger stopper. Typically, syringes are lubricated with silicone oil to reduce friction and make the plunger easier to operate. However, in some cases, syringes may be non-lubricated, such as those designed for specific medical purposes, requiring an alternative lubrication method, like the plunger stopper acting as lubrication.

The test helps evaluate the smoothness and consistency of this movement, which is critical for ensuring that the syringe can be easily operated by healthcare professionals or patients. The glide force test also plays an important role in assessing the overall quality and usability of syringes in clinical settings.

Why is the Syringe Glide Force Test Important?

Ensures Ease of Use: Syringes with excessive glide force can be difficult to use, potentially causing discomfort or even affecting the accuracy of the injection. Testing ensures that the plunger moves smoothly, minimizing user strain.
Checks Lubrication Quality: The glide force test helps assess the quality of the lubrication inside the syringe barrel. Inadequate or inconsistent lubrication can lead to increased resistance, making the injection process more difficult.
Compliance with Standards: The syringe glide force test is part of compliance with several international standards, including ISO 7886-1 and ISO 11040-4. These standards ensure that syringes meet safety and performance requirements.

How Is the Syringe Glide Force Test Performed?

The syringe glide force test is typically performed using a universal tensile and compression testing machine, such as the MST-01 Medical Syringe Tester. The following steps outline the general procedure for the glide force test:

Prepare the Syringe: The syringe is prepared by inserting the plunger stopper into the empty barrel. In the case of non-lubricated syringes, the plunger stopper serves as the lubrication.
Set Test Parameters: The test is conducted at a specific speed (usually around 100 mm/min), though the speed may be adjusted depending on the manufacturer’s requirements.
Measure Glide Force: The force required to move the plunger through the barrel is measured from the point where the plunger begins to move (break loose force) until the sharp increase in force as the plunger reaches the end of its stroke (end of stroke region).
Record Results: The maximum glide force and the average glide force are recorded. These values are compared to the acceptable limits to ensure the syringe meets the required performance criteria.
Repeat Testing: Multiple syringes are tested to ensure consistency and reliability in the results.

ISO 11040-4 and the Syringe Glide Force Test

ISO 11040-4 is the international standard that provides guidelines for testing the glide force of syringes. This standard defines the testing methods, including the required test speed, force range, and the setup for the syringe and plunger stopper.

According to ISO 11040-4, the glide force test should be conducted using a universal tensile and compression testing machine with a test speed of 100 mm/min (or as agreed between the manufacturer and the customer). The standard also recommends using a sampling rate of at least 100 Hz to ensure accurate results, especially when peak force measurements are involved.

Recommended Tool: MST-01 Medical Syringe Tester

The MST-01 Medical Syringe Tester is a highly reliable and precise instrument for conducting syringe glide force tests. It is designed to meet the specifications outlined in ISO 11040-4 and other relevant standards, ensuring that syringes are tested according to the highest industry standards.

Key Features of the MST-01:

Multi-test capabilities, including glide force testing, plunger pull-out tests, and needle penetration tests.
PLC control unit and a 7-inch touch screen for easy operation.
Precision ball screw mechanism for accurate speed and displacement control.
Built-in programs for a range of syringe testing requirements.

The MST-01 is an ideal tool for syringe manufacturers and quality control labs, offering a cost-effective and efficient solution for syringe testing.

FAQs About Syringe Glide Force Test

1. What is the purpose of the syringe glide force test?

The syringe glide force test measures the resistance to the plunger’s movement inside the syringe barrel, which helps assess the lubrication quality and overall usability of the syringe.

2. Why is ISO 11040-4 important for syringe glide force testing?

ISO 11040-4 provides standardized guidelines for performing the syringe glide force test, ensuring that syringes meet required performance and safety standards.

3. What equipment is needed for the syringe glide force test?

A universal tensile and compression testing machine, such as the MST-01 Syringe Tester, is required to perform the glide force test accurately.

4. How do I interpret the glide force test results?

The test results are interpreted by comparing the measured glide force to predetermined acceptable limits. The maximum and average glide forces should fall within these limits for the syringe to be considered compliant.

5. Can non-lubricated syringes be tested for glide force

Yes, non-lubricated syringes can also be tested, and the plunger stopper may act as lubrication in these cases.

Related Products

MST-01 Syringe Plunger Glide Force Tester

Reference

ISO 11040-4