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NPD-01 Needle Penetration and Drag Force Tester

  • 標準: GB 15811, ISO 7864
  • メーカー: セルインストゥルメンツ
  • アプリケーション: 包装資材、医療機器資材、医薬品試験など。
  • カスタマイズ: 特別なテスト要件と自動化変換に利用可能
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Needle Penetration and Drag Force Testing Machine

の Needle Penetration and Drag Force Testing Machine (NPD-01) is a highly specialized instrument designed to measure the forces involved in needle penetration and drag during use. By measuring both the penetration force そして drag force exerted by the needle, the machine helps manufacturers validate the performance of hypodermic needles, lancets, and other needle-based medical devices. This instrument plays an essential role in compliance with international standards such as ISO 7864, which sets the guidelines for testing the performance of needles used in medical applications.

Application of Penetration Force Test

の Needle Penetration and Drag Force Testing Machine is used in a broad range of applications, particularly in industries where the quality of needle-based products is paramount:

  • 医療機器製造: It is essential for manufacturers of hypodermic needles, lancets, and other needles to ensure that their products meet performance specifications, including the ease and comfort of penetration.
  • Pharmaceutical Companies: Testing needles used for drug delivery is critical to ensure that they provide smooth, consistent penetration with minimal discomfort for patients.
  • 研究開発: Researchers working on new needle technologies can use this testing machine to fine-tune their designs, ensuring that they achieve optimal penetration force and drag resistance.
  • 規制遵守: の penetration force test is an important part of regulatory requirements, including those outlined in ISO 7864 そして ISO 7864 Annex D, for needles and medical devices.

Necessity of Needle Penetration and Drag Force Testing

  1. Comfort and Safety: Needles that require excessive force to penetrate or are difficult to maneuver can cause unnecessary pain and discomfort to patients. By measuring the penetration force そして drag force, manufacturers can optimize needle design to minimize pain during injections.
  2. 規制遵守: Medical device manufacturers must ensure their products meet the stringent requirements set out in international standards such as ISO 7864. These standards define the acceptable force values that need to be met for needles to be deemed safe and effective.
  3. Predicting Performance in Clinical Use: Needles must not only penetrate tissue but also move smoothly once inserted. Testing both drag force そして penetration force ensures that the needle performs optimally during injections, improving overall patient care and minimizing complications.

Needle Penetration Test Principle

の Needle Penetration and Drag Force Testing Machine operates on a precise and repeatable process that measures the force involved in needle insertion. Here’s how it works:

  1. Needle Insertion Setup: の testing needle is inserted into a substrate using a male luer taper, which connects to the load cell. The needle is positioned in such a way that it will move through a material that mimics skin or other tissue.
  2. Penetration Force Measurement: As the needle is pushed into the material, the load cell continuously measures the force required for insertion. This measurement is recorded at various depths during the test.
  3. Drag Force Assessment: After the initial penetration, the machine evaluates the drag force—the resistance encountered as the needle moves through the material. This is a critical step, as it provides insight into the needle’s performance in real-world clinical applications.
  4. データ収集: The collected data, including both initial penetration force そして drag force values, is displayed on the machine’s user-friendly HMIタッチスクリーン and is automatically printed via the integrated microprinter for record-keeping.

This process ensures that both the penetration and drag forces are precisely measured, providing manufacturers with the data needed to evaluate the quality and performance of their needles.

Technical Specification

Loadcell50N（または必要に応じて）
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

  • Fixtures: Includes multiple fixtures for different needle testing scenarios, including drag force test and downward force tests
  • 高精度: With an accuracy of 0.01 mm and 0.5% force accuracy, the machine ensures precise and reliable measurements.
  • 汎用性: The adjustable test speed and customizable load cell capacity make this machine suitable for a variety of needle types and testing requirements.
  • 使いやすさ: The HMI touchscreen simplifies test setup and operation, while the integrated microprinter ensures efficient documentation of results.
  • Automated Testing: The automatic return function and overload protection enhance safety and make the testing process more efficient.

Configurations and Accessories

の Needle Penetration and Drag Force Testing Machine comes with a full set of accessories designed for different testing applications:

  • Main Machine: The core testing unit, designed for precision and durability.
  • Substrate Holder: Holds the material in place during testing, ensuring accurate measurements.
  • Power Cord: Compatible with a wide voltage range (110~220V) for global usage.
  • Fuse: Protects the device from electrical overloads.
  • Needle Fixtures: Various fixtures are available to test different types of needles, ensuring versatility in testing different needle designs and sizes.

Needle Penetration Test Method Relateed Standard

の Needle Penetration and Drag Force Testing Machine is designed to meet international standards, including:

ISO 7864

Sterile hypodermic needles for single use — Requirements and test methods

Annex D – Test method for measuring the penetration force and drag force for needles

Other Standard

GB 15811

Support and Training

Cell Instruments offers comprehensive support and training services to help you get the most out of your Needle Penetration and Drag Force Testing Machine:

  • Operator Training: Detailed training programs to ensure your team can effectively use the machine.
  • テクニカルサポート: Ongoing support for troubleshooting, calibration, and maintenance.
  • Calibration Services: Regular calibration services to maintain the machine’s accuracy and reliability.

よくある質問（FAQ）

Q1: How does the Needle Penetration and Drag Force Testing Machine measure drag force?
A1: The machine measures drag force by recording the resistance encountered as the needle moves through the material after initial penetration.

Q2: Can this machine be used for testing other types of needles?
A2: Yes, the machine is versatile and can be used for testing a variety of needles, including hypodermic needles, lancets, and syringes.

Q3: Is the NPD-01 machine compliant with ISO 7864?
A3: Yes, the machine fully complies with ISO 7864 そして ISO 7864 Annex D, ensuring it meets the necessary testing standards for medical devices.

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