NPD-01 Needle Penetration and Drag Force Tester

The NPD-01 Needle Penetration and Drag Force Tester is a cutting-edge instrument designed for precise measurement of penetration forces required for hypodermic needles. It ensures compliance with international testing standards such as ISO 7864 and GB 15811, offering a robust solution for testing needle performance in various medical applications, including injection devices, testing needles, and other biomedical products.

Penetration and Drag Force Test Application

The Needle Penetration Force Measurement Instrument is essential for testing needles used in a wide range of medical, pharmaceutical, and research applications. Key areas of application include:

• Medical Devices & Pharmaceuticals: Ensuring that hypodermic needles, lancets, and other sharp medical devices provide smooth, pain-minimizing insertion while maintaining reliability in clinical settings.
• Needle Manufacturers: Quality assurance in production lines for hypodermic needles, syringes, and other needle-based instruments.
• Medical Research: Testing new needle designs and formulations for improved clinical outcomes.
• Packaging: Ensuring that medical packaging for needles and syringes is properly designed to withstand the forces involved in needle insertion and drug delivery systems.

Necessity of Needle Penetration Testing

Understanding the needle penetration test method is fundamental for ensuring the safety and effectiveness of medical needle devices. Testing the penetration force and drag force serves a dual purpose:

1. Patient Comfort: Excessive force or friction can cause pain, anxiety, and complications during injection. By evaluating the force required for insertion and movement, manufacturers can design needles that minimize discomfort.
2. Clinical Efficacy: Efficient needle insertion is crucial in clinical settings. Needles must penetrate the skin or tissue easily, but without causing tissue damage or affecting the quality of drug delivery.
3. Regulatory Compliance: International standards such as ISO 7864 and GB 15811 demand that needles meet specific performance criteria. The NPD-01 tester guarantees adherence to these regulations, reducing the risk of regulatory non-compliance.

Without precise testing, needle-based products could fail in crucial areas such as sterility, injection smoothness, 그리고 user experience, potentially leading to clinical complications and patient discomfort. Therefore, the needle penetration test is not just a technicality; it’s a necessity for the integrity of the healthcare system.

Needle Penetration Test Method

The NPD-01 Needle Penetration Force Measurement Instrument operates on a sophisticated yet user-friendly principle:

1. Setup: The needle to be tested is secured in place using a male luer taper, which connects to the load cell.
2. Substrate Insertion: The needle is moved towards a specific substrate (such as skin-like materials or synthetic tissues) at a controlled speed.
3. Force Measurement: During insertion, a load cell continuously measures the force applied as the needle penetrates the material. This force is recorded at different stages of the insertion process.
4. Drag Force Assessment: After the initial penetration, the drag force or the frictional force required to move the needle through the material is measured. This is a critical indicator of the performance of the needle during actual use.
5. Data Output: The system outputs data via an intuitive HMI touchscreen and prints results using an integrated micro printer.

The force readings obtained from the test provide a detailed view of both initial peak penetration force and friction forces, making it a valuable tool for quality control, R&D, and regulatory compliance.

Technical Specification of Needle Drag Force Tester

Here are the key technical features of the NPD-01 Needle Penetration and Drag Force Tester:

Loadcell	50N (or as required)
Test Speed	1~500mm/min
Force Accuracy	0.5% F.S.
Accuracy	0.01mm
Power	110~220V

Technical Feature of Needle Penetration Force Tester

1. Precision and Reliability: With an accuracy of 0.01mm and force measurement accuracy of 0.5%.
2. Versatility: The instrument accommodates various needle sizes and types, allowing for comprehensive testing across a wide range of medical devices.
3. Ease of Use: The PLC-controlled system and intuitive HMI touchscreen make it easy for operators to set up, monitor, and interpret tests.
4. 사용자 정의: The variable speed settings and adjustable penetration depth ensure that the device can be tailored to specific testing requirements.
5. Compliance with Standards: Fully adheres to international standards like ISO 7864 and GB 15811, making it suitable for regulatory testing in various regions.

Needle Penetration Test Standard

The NPD-01 Needle Penetration Force Measurement Instrument complies with various international standards, making it suitable for medical and pharmaceutical testing worldwide:

ISO 7864 Annex D

• Specifies the test method for measuring the penetration force and drag force of needles, which is central to ensuring their performance during use.

GB 15811

• This Chinese standard outlines specific methods for the needle penetration test, which the NPD-01 adheres to.

Using this instrument ensures that your products meet the highest industry standards and are suitable for regulatory approval in different markets.

Support and Training

Cell Instruments provides comprehensive support and training to help users get the most out of the NPD-01 Needle Penetration Force Measurement Instrument:

• User Training: Our training programs are tailored to help you understand the operation of the instrument and the principles of needle testing.
• Technical Support: We offer ongoing technical support for troubleshooting, maintenance, and calibration.
• Calibration Services: To ensure continued accuracy, we provide professional calibration services on an annual basis.

Frequently Asked Questions (FAQ)

Q1: What are the benefits of testing needle drag force?
A1: Testing the drag force ensures that the needle moves smoothly through tissues, reducing discomfort and improving clinical effectiveness. It also helps to predict the performance of needles under various conditions.

Q2: Can this tester be used for testing different types of needles?
A2: Yes, the NPD-01 is versatile and can test a wide range of needles, including syringes, lancets, and hypodermic needles. It includes multiple fixtures for various needle sizes.

Q3: Is the NPD-01 compliant with international testing standards?
A3: Yes, the NPD-01 adheres to ISO 7864 and GB 15811, ensuring it meets global testing standards for medical devices.

Q4: What kind of data does the NPD-01 output?
A4: The NPD-01 provides both real-time force measurements and penetration depth data, with results available through the HMI touchscreen and an integrated microprinter.