背景

Injection needle tube toughness tester

2026-03-20 09:55
The syringe needle toughness test strictly complies with the following national and international standards to ensure accurate and compliant test results, suitable for quality inspection in the medical device industry and can be directly used for product details and specification sections on foreign trade platforms.
Core Compliance Standards

  • GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices (modification adopted ISO 9626:1991, currently valid, replacing relevant previous versions)

  • YY/T 0282-2024 Hypodermic needles (latest edition, suitable for performance testing of various medical hypodermic needles)

  • GB 15811-2016 Sterile hypodermic needles for single use (specifies requirements for toughness testing of single-use injection needles)

  • ISO 9626:1991 (international standard, equivalent to GB/T 18457-2015, suitable for export testing requirements)

Test Requirements Corresponding to Standards

  1. Toughness test: In accordance with the appendix of GB/T 18457-2015, the reciprocating bending method is adopted to conduct cyclic bending tests on needle tubing at a fixed span and specified angle, to determine whether the needle tubing has breakage, cracks or plastic deformation.

  2. Test parameter adaptation: Bending angle (15°/20°/25°), bending frequency (0.5Hz) and cycle times (default 20 times, adjustable) can be accurately set according to standard requirements, fully meeting standard test specifications.

  3. Judgment of conformity: In strict compliance with the above standards, after testing, the needle tubing shall be free of visible breakage or cracks under normal or corrected vision, which meets medical device quality control requirements.

Note: This device is compatible with the new standard GB/T 18457-2024 (implemented on September 1, 2025).  

Parameter adaptation can be completed according to customer requirements without additional modification.


Jinan Vieleader Instrument Co., Ltd. is a professional manufacturer specialized in R&D, production and sales of precision testing instruments for medical devices.The company focuses on quality control equipment for medical needles, pharmaceutical packaging and medical consumables, with products designed in full compliance with national and international standards.Adhering to the principle of precision, stability and reliability, Vieleader provides professional testing solutions, technical support and after-sales service for medical manufacturers, testing institutions and research laboratories around the world.

GB18457-2015

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