The new standard GB15811-2025 "Disposable Aseptic Injection Needles" will be officially implemented in 2025, replacing the old version of the standard that has been in use for many years. As one of the core indicators for quality testing of injection needles, the requirements for puncture force testing have been comprehensively upgraded in the new standard, directly promoting the updating and iteration of testing equipment for medical device enterprises. The MCT-02H medical needle puncture force tester, with its high adaptability to new standards, has become the core choice for compliant production and precise monitoring by testing institutions.

1、 Core reasons for the change of GB15811-2025 new standard

1. In response to clinical safety and comfort requirements, the old version standards have relatively broad limitations on puncture force. Some injection needles have excessive puncture force, which can easily lead to increased patient pain, vascular damage, and even affect the safety of injection operations. The new version of the standard focuses on the pain points of clinical practical application, and by refining the requirements for puncture force, it forces enterprises to improve product design and production processes, reducing medical risks during the injection process.

2. In line with international standards and industry development, as the internationalization process of China's medical device industry accelerates, the new version of the standard fully refers to standards such as ISO 7864:2016, adjusts testing methods and technical indicators, achieves technical docking with the international market, and helps domestic injection needle products participate in global competition.

3. To fill the gaps in the detection of old standards, the puncture force testing method of old standards has problems such as single simulation environment and poor data repeatability, which makes it difficult to fully reflect the puncture performance of injection needles in actual use scenarios. The new version of the standard optimizes the testing process and judgment rules, making the testing results more scientific and accurate.

2、 GB15811-2025 Testing Methods and Requirements for Puncture Force

1. Core testing methods

Test sample: Select a complete disposable sterile injection needle, remove the protective cover, and fix it vertically on the test fixture.

Simulation medium: Using standard simulated skin that meets the requirements of GB/T 14233.1 (thickness 2.0mm ± 0.1mm, hardness Shore A 50 ± 5), simulate the characteristics of human skin tissue.

Test parameters: The puncture speed is set to 100mm/min ± 10mm/min, and the puncture depth is not less than 10mm, ensuring that the needle tip penetrates the simulated medium. -Data collection: Real time recording of the maximum force value during the puncture process as the core detection data for puncture force.

2. Key qualification requirements

The upper limit of puncture force for different specifications of injection needles is clearly limited: 23G injection needle ≤ 8.0N, 25G injection needle ≤ 6.0N, 27G injection needle ≤ 4.0N (specific standard text shall prevail).

The coefficient of variation of puncture force test results for the same batch of samples is ≤ 15% to ensure product quality consistency. During the puncture process, the needle tip must not show any bending, breakage or other failure phenomena, otherwise it will be judged as unqualified.

3、 MCT-02H Medical Needle Puncture Force Tester

The MCT-02H medical needle puncture force tester has been designed with reference to ISO 7864:2016 since its inception, and has now accumulated a number of customers in South Asia, Southeast Asia, Europe, and other regions. Now that the domestic standards are in line with ISO7864:2016, can the MCT-02 medical needle puncture force tester help domestic injection needle manufacturers achieve product qualification testing.

1. Core technical parameters, matching standard requirements

2. Force measurement range: 0-50N, measurement accuracy ± 0.01N, meeting the puncture force detection requirements of different specifications of injection needles, with data errors far below the standard allowable range.

3. Testing speed: 0.1-600mm/min continuously adjustable, accurately setting the standard testing speed of 100mm/min, supporting custom speed parameters to adapt to special testing scenarios.

4. Simulation media adaptation: Standard simulated skin in accordance with GB/T 14233.1 is standard, supporting the replacement of media with different thicknesses and hardness, and adapting to diverse testing needs.

5. Travel range: 0-100mm, puncture depth can be accurately set to ensure that the needle tip penetrates the medium and meets the requirements of standard testing procedures.

2. Intelligent functions to improve detection efficiency and reliability

3. Automated operation: Supports automatic sample clamping, automatic puncture, automatic data collection and calculation, reduces manual intervention, avoids human errors, and improves test repeatability.

4. Data processing capability: Real time display of puncture force displacement curve, automatic extraction of maximum puncture force value and resistance test, support for automatic data storage, and meet the requirements of quality traceability and report generation.

5. Safety protection design: equipped with emergency stop button, overload protection device, and transparent protective cover in the testing area to ensure the safety of operators.

6. Multi scenario adaptation to meet the requirements of quality control throughout the entire process

7. Factory inspection of production enterprises: It can achieve rapid testing of batch samples, complete 50-80 sample tests per hour, efficiently screen unqualified products, and ensure 100% compliance of factory products.

8. Registration application and certification testing: Provide complete testing data and reports that comply with GB15811-2025 standards to support product registration application, CE/FDA international certification, and assist in the rapid and compliant launch of products.

9. Third party testing and regulatory enforcement: Provide precise testing tools for quality inspection agencies and regulatory departments for market spot checks, quality arbitration, and maintaining industry quality order.

10. Stable and reliable product advantages ensure long-term use

11. Support software online upgrade, which can quickly adapt to future standard revisions and technical upgrade requirements, avoiding the risk of equipment obsolescence.

12. Equipped with a professional technical team, providing one-stop services such as on-site installation, operation training, and after-sales maintenance to address user concerns.

The implementation of the new standard GB15811-2025 is an important opportunity for the quality upgrade of the injection needle industry.