ISO 9626
Syringe Needle Tubing Test

ISO 9626 defines the international standard for stainless steel needle tubing used in the manufacture of medical devices such as hypodermic needles. Developed to ensure safety, consistency, and performance, ISO 9626 provides rigorous specifications for tubing dimensions and mechanical properties ranging from 3.4 mm (10 Gauge) to 0.18 mm (34 Gauge). It applies strictly to rigid stainless steel tubing—excluding flexible variants—making it essential for syringe needle manufacturers and medical device producers.

For quality control professionals and medical device manufacturers, understanding ISO 9626 is crucial. This standard not only governs the design of medical tubing but also prescribes specific tests such as the syringe needle tubing test, needle stiffness test, tubing break resistance test, and needle corrosion resistance test.

Let’s explore the key testing methods required by ISO 9626 and how manufacturers can ensure compliance using specialized equipment like Cell Instruments’ TS-01 and NTT-01.

Syringe Needle Tubing Test Requirements Under ISO 9626

To ensure a stainless steel needle tube meets this standard, manufacturers must evaluate it against several critical performance metrics. These include:

Dimensional accuracy
Wall thickness category (RW, TW, ETW, UTW)
Material strength and integrity
Resistance to deformation and corrosion

Each metric is associated with standardized testing procedures to ensure tubing quality throughout production and prior to use in syringes and other medical devices.

1. Needle Stiffness Test – ISO 9626 Annex B

The needle stiffness test evaluates the tubing’s ability to resist deflection under an applied force. According to Annex B of this standard, a plunger applies up to 60 N force to the center of a needle tube supported at both ends. The deflection is then precisely measured.

This test ensures the tubing retains structural integrity during insertion into the human body without bending or buckling.

Recommended Instrument: TS-01 Tubing Stiffness Tester
Cell Instruments’ TS-01 is specifically designed for stiffness testing in compliance with ISO 9626 Annex B. It offers:

±0.01 N force accuracy
0.01 mm deflection measurement resolution
Variable test speeds (1–500 mm/min)
7-inch HMI touchscreen operation
Automatic return and overload protection

With the TS-01, quality control teams can confidently evaluate the mechanical rigidity of needle tubing.

2. Tubing Break Resistance Test – ISO 9626 Annex C

ISO 9626 Annex C defines the tubing break resistance test, which assesses the fatigue performance of the tubing through repeated bending cycles. The tubing is fixed at one end and bent to specified angles (25°, 20°, or 15°, depending on wall thickness) for 20 complete cycles at 0.5 Hz.

This test simulates clinical use and ensures that the tubing can withstand repeated stress without failure.

Recommended Instrument: NTT-01 Syringe Needle Break Resistance Tester
Cell Instruments’ NTT-01 is tailored to execute tubing break resistance testing under the exact parameters of ISO 9626 Annex C. It ensures:

Accurate control of angular displacement
Adjustable force application
Consistent cycling rate for fatigue evaluation

Using the NTT-01 helps manufacturers avoid tubing breakage issues that could compromise patient safety.

3. Needle Corrosion Resistance Test – ISO 9626 Annex D

The needle corrosion resistance test measures the tubing’s ability to withstand chemical exposure. As per ISO 9626 Annex D, the tubing is partially immersed in a 0.5 mol/L sodium chloride solution for seven hours at 23 °C. After immersion, the tubing is inspected for visible corrosion.

This test is vital for confirming the biocompatibility and long-term durability of the stainless steel needle.

To support this procedure, Cell Instruments offers corrosion resistance testing setups compatible with ISO 3696 water standards and appropriate reagent handling systems.

Benefits of Complying with ISO 9626

Compliance with this standard ensures that syringe needle tubing:

Meets international safety standards
Minimizes the risk of bending, breakage, or corrosion
Enhances patient comfort and device reliability
Streamlines regulatory approvals

Additionally, adherence to ISO 9626 helps build trust with healthcare professionals and end-users while reducing product recalls or clinical failures.

Partnering with Cell Instruments for ISO 9626 Compliance

Cell Instruments is a trusted manufacturer of advanced needle tubing testing systems. We offer high-performance equipment tailored to meet this standard testing requirements for syringe needle tubing, including stiffness, break resistance, and corrosion resistance.

Our TS-01 and NTT-01 instruments are designed with precision control, high repeatability, and intuitive operation—ideal for quality assurance labs, syringe manufacturers, and medical device developers.

ISO 9626

By working with Cell Instruments, you gain access to:

Equipment designed for strict ISO compliance
Customizable testing solutions for unique product needs
Ongoing technical support and calibration services

Understanding and implementing ISO 9626 standards is essential for anyone involved in the design, manufacture, or quality control of medical needle tubing. By performing accurate syringe needle tubing tests, including needle stiffness, tubing break resistance, and needle corrosion resistance tests, manufacturers can guarantee performance, safety, and global compliance.

Cell Instruments is your reliable partner in achieving ISO 9626 testing success. With our expert-grade TS-01 and NTT-01 systems, you’ll meet the toughest industry demands with confidence.

FAQ

1. What types of stainless steel tubing does ISO 9626 cover?
This standard applies only to rigid stainless steel tubing used in hypodermic needles and excludes flexible tubing due to different mechanical properties.

2. Why is the needle stiffness test important?
It ensures that the tubing resists bending during medical use, which is crucial for safe needle insertion and precise drug delivery.

3. How many bending cycles are required in the break resistance test?
ISO 9626 Annex C requires the tubing to undergo 20 complete cycles of directional bending to evaluate its fatigue strength.

4. What signs indicate failure in the corrosion resistance test?
Visible corrosion or discoloration on the immersed portion of the tubing indicates non-compliance with ISO 9626 Annex D.

5. Can Cell Instruments provide customized needle tubing test equipment?
Yes, Cell Instruments specializes in custom testing solutions, including automation and tailored fixtures, to support specific product and regulatory needs.

ISO 9626 Syringe Needle Tubing Test