TS-01 Syringe Tube Stiffness Tester - ISO 9626 Annex B

TS-01 Tube Stiffness Tester

  • Стандарт: ISO 9626
  • Производитель: Клеточные инструменты
  • Приложения: материалы для медицинских приборов, фармацевтические испытания и многое другое.
  • Настройка: Доступно для специальных требований к тестированию и автоматизированным преобразованиям
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Introduction to Syringe Tube Stiffness Tester

For professionals in medical device manufacturing, syringe tube stiffness plays a critical role in ensuring the reliability, safety, and usability of hypodermic needles. The Syringe Tube Stiffness Tester, specifically designed to evaluate the stiffness of stainless steel needle tubing, provides a reliable method for quality control and standard compliance. This instrument, such as Cell Instruments’ TS-01, is indispensable for meeting the requirements outlined in ISO 9626.

Stiffness is directly linked to mechanical integrity. Tubing that lacks appropriate stiffness may bend, break, or deform during use—posing risks of injury, inaccurate dosing, or contamination. Conversely, overly rigid tubing may fail to provide adequate flexibility, leading to fracture or discomfort. The Syringe Tube Stiffness Tester addresses these challenges by delivering precise, repeatable measurements that conform to global standards.

ISO 9626 and Syringe Tube Stiffness Testing Standards

ISO 9626, specifically Annex B, defines the standard test method for measuring the stiffness of stainless steel needle tubing. This long tail keyword—ISO 9626 testing—is essential for manufacturers who must demonstrate compliance with international medical device regulations.

According to ISO 9626 Annex B:

  • The tubing is supported at both ends while a force—up to 60 N—is applied to its midpoint using a wedge-shaped plunger.
  • The resulting deflection is measured with a precision of 0.01 mm.
  • The test ensures that the tubing’s stiffness is within acceptable limits for the intended medical application.

The Syringe Tube Stiffness Tester from Cell Instruments is engineered to fulfill each of these requirements, making it ideal for quality assurance teams and regulatory bodies.

Working Mechanism and Structure of TS-01 Syringe Tube Stiffness Tester

The TS-01 Syringe Tube Stiffness Tester employs a robust and accurate system designed to minimize measurement errors. It uses:

  • А wedge-shaped plunger with a 1 mm radius, inclined at 60°, as specified in ISO 9626 Annex B.
  • А precision load cell and movable crosshead to ensure accurate force application.
  • А tubing pan that centers the test sample directly beneath the plunger.

This configuration mimics the ISO-specified test conditions, ensuring reproducibility and data integrity.

System Highlights:

  • ПЛК-управление и 7-дюймовый сенсорный экран HMI interface
  • Precision ball screw drive for consistent speed control
  • Variable speed from 1 to 500 mm/min for customized testing
  • High-resolution deflection measurement (0.01 mm)
  • Защита от перегрузки for equipment and sample safety
  • Automatic return function post-test
  • Integrated microprinter for immediate result documentation

Test Principle and Methodology Explained

The principle of the stiffness test is straightforward but scientifically grounded:

  1. Positioning: The syringe tubing is supported at both ends at a span length specified in ISO 9626 Table 2.
  2. Приложение силы: The plunger applies a downward force at the midpoint, with control over speed (1–10 mm/min for ISO 9626; up to 500 mm/min for customizable tests).
  3. Deflection Measurement: The instrument measures the tubing’s deflection with ±0.01 mm accuracy.
  4. Запись данных: Information such as tubing size, material, deflection, test speed, and force applied are recorded and printed.

This test ensures compliance with both ISO and internal quality benchmarks.

Why Choose Cell Instruments’ TS-01 Syringe Tube Stiffness Tester?

Cell Instruments has built a reputation for precision, compliance, and customizability. The TS-01 Syringe Tube Stiffness Tester offers exceptional accuracy and robust features tailored for syringe manufacturing and quality labs. Our team also supports customized test requirements и automation solutions, ensuring integration with existing workflows in packaging, pharmaceuticals, and medical device production.

Applications and Industries Served

The Syringe Tube Stiffness Tester is widely used across multiple sectors:

  • Medical device manufacturing
  • Pharmaceutical production
  • Healthcare packaging
  • Regulatory compliance and testing labs
  • Quality assurance for needle manufacturers

Whether you’re validating product safety, meeting ISO 9626 testing criteria, or ensuring mechanical reliability, the TS-01 is your go-to solution.

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