NPD-01 Needle Penetration and Drag Force Tester

Den NPD-01 Needle Penetration and Drag Force Tester is a precision instrument designed to measure the penetration and drag forces exerted when a needle is inserted into a substrate. These forces play a crucial role in the safety and comfort of hypodermic needles, ensuring they function efficiently during medical procedures. This testing equipment is widely used in the medical industry to evaluate the performance of needles, particularly for hypodermic and other medical needles, in line with ISO 7864 og GB 15811 standards.

In medical applications, especially with injectable devices, understanding the forces involved in needle penetration is crucial. The NPD-01 Needle Penetration Force Tester enables manufacturers, researchers, and quality assurance teams to test and verify these forces, ensuring the needles are safe, comfortable, and easy to use. The data collected during testing provides critical insights into the frictional characteristics and penetration force, directly influencing needle design and material selection.

Applications

The NPD-01 Needle Penetration and Drag Force Tester is essential for industries that deal with medical devices, especially those producing hypodermic needles og syringes. The key applications include:

1. Needle Design and Manufacturing: Manufacturers use the NPD-01 Needle Penetration Force Tester to assess the performance of needles at different stages of production, from design validation to final product testing.
2. Medical Device Research and Development: R&D departments use this tester to explore new needle designs or materials that reduce pain or improve efficacy during injections.
3. Quality Control in Medical Facilities: The NPD-01 Needle Penetration Force Tester ensures that each batch of needles meets the required safety and comfort standards before reaching the market.
4. Overholdelse af lovgivningen: The tester helps ensure that products comply with international standards such as ISO 7864, providing essential data for product certifications.
5. Needle Compatibility Testing: Used to assess the interaction between needles and other materials in medical devices, including syringes, catheters, and delivery systems.

Necessity of Needle Penetration and Drag Force Testing

Why You Must Need It

The importance of needle penetration testing og drag force testing cannot be overstated in the context of patient safety and device performance. Medical needles must be easy to insert while minimizing discomfort and trauma to the skin and tissue. These factors directly influence the patient experience and are crucial for:

• Patient Comfort: Lower penetration forces contribute to less pain during injection.
• Clinical Effectiveness: Proper drag forces ensure smooth insertion and reduce the risk of damage to tissues or complications during injection.
• Overholdelse af lovgivningen: Meeting ISO 7864 og GB 15811 standards is essential for market approval in various countries.
• Needle Safety: Excessive forces during insertion can compromise the integrity of both the needle and the tissue being pierced, leading to complications.

By using the NPD-01 Needle Penetration and Drag Force Tester, manufacturers ensure that their products meet these critical requirements and avoid potential harm to patients.

Working Principle

The working principle of the NPD-01 Needle Penetration and Drag Force Tester involves inserting a needle into a specified substrate and recording the forces during the insertion process. The machine operates under the following steps:

1. Needle Insertion: The needle is held securely by the machine and inserted into a substrate (e.g., synthetic skin, rubber) at a constant speed.
2. Force Measurement: As the needle moves through the substrate, the load cell measures the penetration force (initial peak force required to break the surface) and drag force (force required to keep the needle moving through the material).
3. Data Recording: The system records force values at various penetration depths, allowing for a detailed analysis of the needle’s performance.
4. Force Profile: The resulting graph helps researchers and manufacturers understand how the needle behaves under different conditions and optimize its design accordingly.

Den NPD-01 Needle Penetration Force Tester can adjust variables such as test speed (1–500 mm/min) and penetration depth, making it versatile for a wide range of needle types and applications.

Technical Specifications

Advantages

Den NPD-01 Needle Penetration and Drag Force Tester offers several key advantages:

1. High Precision: Accurate force measurements with an accuracy of 0.5% of full scale ensure reliable data for needle testing.
2. Versatility: With adjustable test speeds and penetration depths, the NPD-01 Needle Penetration Force Tester accommodates a wide range of needles and substrates.
3. Ease of Use: The intuitive touchscreen interface and PLC control make the NPD-01 Needle Penetration Force Tester simple to operate, even for non-technical users.
4. Safety Features: The overload protection system ensures that the device operates within safe limits, preventing damage to both the tester and the test needle.
5. Automatic Return: After completing a test, the needle automatically returns to its original position, improving workflow efficiency.

By integrating these features, the NPD-01 Needle Penetration Force Tester provides an excellent balance between accuracy, ease of use, and operational safety.

Configurations and Accessories

Den NPD-01 Needle Penetration and Drag Force Tester comes with several configuration options and accessories:

• Main Machine: The core unit featuring the load cell and motorized driving system.
• Substrate Holder: Customizable holders to accommodate various types of substrates for penetration testing.
• Power Cord and Fuse: Included for standard operation.
• Microprinter: For printing out test results, providing physical documentation of each test conducted.
• Additional Fixtures: Multiple fixtures are available for downward force tests, ideal for testing syringes, catheters, and other medical devices.

Standarder

The NPD-01 complies with international standards for needle penetration testing og drag force testing, including:

• ISO 7864 Annex D: Provides guidelines for the testing of the penetration force og drag force for hypodermic needles. Ensuring compliance with ISO standards is essential for regulatory approval.
• GB 15811: A Chinese national standard for testing hypodermic needles and ensuring they meet specific safety and comfort criteria.

These standards ensure that the test results are recognized globally and that the equipment is suitable for quality control, regulatory certification, and product development.

Support and Training

Cell Instruments offers comprehensive support and training for users of the NPD-01 Needle Penetration and Drag Force Tester:

• Product Setup and Installation: Our expert team will assist with the installation and setup of the tester, ensuring it operates to its full potential.
• Technical Training: We provide in-depth training on how to use the tester effectively, covering all test parameters and operational guidelines.
• Maintenance and Support: Ongoing support is available to troubleshoot and maintain the tester, ensuring that it continues to perform accurately and reliably.

Frequently Asked Questions (FAQ)

1. What is the main purpose of the NPD-01 Needle Penetration and Drag Force Tester?
The main purpose is to measure the forces required for a needle to penetrate and move through a substrate, which is critical for ensuring the performance, safety, and comfort of hypodermic needles.

2. What standards does the NPD-01 comply with?
The NPD-01 complies with ISO 7864 Annex D og GB 15811, which are international standards for needle penetration and drag force testing.

3. What materials can be tested with the NPD-01?
The NPD-01 can test a wide variety of materials, including synthetic skin, rubber, and other substrates commonly used for medical device testing.

4. How accurate are the force measurements?
The NPD-01 has a force accuracy of 0.5% full scale, providing highly reliable and precise results for your testing needs.

5. Can the NPD-01 be used for other types of needle testing besides hypodermic needles?
Yes, the NPD-01 can be used for testing various types of needles, including syringes, catheters, and other medical devices.