TS-01 Tube Stiffness Tester

Introduction to Medical Needle Tubing Stiffness Tester

Ensuring the mechanical integrity of hypodermic needles is critical in the medical field. One essential property that influences performance, safety, and usability is tubing stiffness. The medical needle tubing stiffness tester provides a standardized, precise method to evaluate the stiffness of stainless steel tubing used in needle manufacturing. With the rise in global medical standards, especially compliance with ISO 9626 and ISO 9626 Annex B, reliable testing solutions have become indispensable for medical device manufacturers, quality control professionals, and research institutions.

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Importance of Needle Tubing Stiffness in Medical Applications

Stiffness directly affects a needle’s insertion ability, structural integrity, and user control. A needle tube that is too soft may bend or break, risking patient injury or improper medication delivery. Conversely, an overly stiff needle may snap or cause unnecessary trauma during insertion. Therefore, achieving an optimal balance is essential. The medical needle tubing stiffness tester plays a vital role in quantifying this balance and maintaining production standards.

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ISO 9626 Testing – ISO 9626 Annex B

The international standard ISO 9626:2016 outlines the mechanical and dimensional requirements for stainless steel tubing intended for hypodermic needles. Annex B provides a specific method for measuring stiffness:

• A known force (up to 60 N) is applied centrally to the tubing supported at both ends.

• The resulting deflection is measured with 0.01 mm precision.

• The apparatus must include a blunt wedge-shaped plunger, inclined at 60°, with a 1 mm radius cylindrical surface.

The TS-01 Medical Needle Tubing Stiffness Tester is designed specifically to fulfill this testing method, ensuring strict compliance with ISO standards.

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Test Principle and Working Mechanism

The medical needle tubing stiffness tester operates on a simple yet effective principle:

A precise force is applied to the midpoint of the tubing, which is symmetrically supported. The instrument then records the vertical deflection, providing quantitative stiffness data.

The TS-01 model by Cell Instruments features:

• A blunt wedge-shaped plunger connected to a load cell, ensuring high measurement accuracy (±0.01 N).

• A movable crosshead powered by a precision ball lead screw.

• A tubing holder (pan) that aligns the test sample accurately under the force plunger.

• Variable test speed (1–500 mm/min) to accommodate different tubing sizes and materials.

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Why Choose the TS-01 Medical Needle Tubing Stiffness Tester

As a manufacturer of precision testing instruments, Cell Instruments designed the TS-01 specifically for medical needle manufacturers. Key benefits include:

• Full compliance with ISO 9626 and ISO 9626 Annex B.

• High-resolution deflection measurement up to 0.01 mm.

• Robust design with overload protection and automatic return functions.

• User-friendly 7-inch touch screen HMI for test control and data review.

• Built-in microprinter for instant report output.

These features not only streamline testing but also improve the accuracy, repeatability, and documentation required for medical product validation and regulatory audits.

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Applications Across Medical Manufacturing and Research

The medical needle tubing stiffness tester is widely applicable in:

• Hypodermic and pen needle manufacturing

• Quality control departments in medical device production

• Research and development labs working on innovative needle designs

• Regulatory testing agencies and inspection bodies

• OEMs and private-label medical component suppliers

It provides critical mechanical data that ensures each needle tube performs reliably under clinical use conditions.

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Technical Specifications at a Glance

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FAQ: Medical Needle Tubing Stiffness Tester

Q1: What type of needles or tubing can be tested with this instrument?
A1: It is suitable for stainless steel needle tubing used in hypodermic, pen, or intravenous needles.

Q2: Can I test different tubing sizes?
A2: Yes, the tester includes adjustable fixtures and supports different spans as per ISO Table 2 specifications.