の NPD-01 針貫入力および抗力試験装置 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 7864 規格 そして イギリス 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

の 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.
パッケージ: 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 そして drag force serves a dual purpose:

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.
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.
規制遵守: International standards such as 7864 規格 そして イギリス 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、そして 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

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

設定: The needle to be tested is secured in place using a male luer taper, which connects to the load cell.
Substrate Insertion: The needle is moved towards a specific substrate (such as skin-like materials or synthetic tissues) at a controlled speed.
力の測定: 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.
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.
データ出力: The system outputs data via an intuitive HMIタッチスクリーン 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 そして 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 針貫入力および抗力試験装置:

ロードセル	50N (or as required)
テスト速度	1〜500mm/分
力の精度	0.5% FS
正確さ	0.01ミリメートル
力	110〜220V

Technical Feature of Needle Penetration Force Tester

精度と信頼性: With an accuracy of 0.01mm and force measurement accuracy of 0.5%.
汎用性: The instrument accommodates various needle sizes and types, allowing for comprehensive testing across a wide range of medical devices.
使いやすさ: The PLC-controlled system and intuitive HMIタッチスクリーン make it easy for operators to set up, monitor, and interpret tests.
カスタマイズ: The variable speed settings and adjustable penetration depth ensure that the device can be tailored to specific testing requirements.
標準への準拠: Fully adheres to international standards like 7864 規格 そして イギリス 15811, making it suitable for regulatory testing in various regions.

Needle Penetration Test Standard

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

7864 規格 Annex D

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

イギリス 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.

よくある質問（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 7864 規格 そして イギリス 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タッチスクリーン and an integrated microprinter.

NPD-01 針貫入力および抗力試験装置