Introduction to ISO 7864

ISO 7864 is an international standard that specifies requirements for sterile hypodermic needles intended for single use. This standard ensures the safety, reliability, and performance of medical needles by covering critical aspects such as dimensions, strength, sharpness, and functionality. Specifically, ISO 7864 addresses needle bonding strength, flow rate through the needle (patency of lumen), penetration force, and drag force for needles. Additionally, it includes provisions for sharps injury protection in accordance with ISO 23908 and requires that the conical socket of the hypodermic needle hub meet the requirements of ISO 80369-1. Needles according to the tubular needle designation must also comply with ISO 9626.

The Role of Needle Puncture Tester in Quality Assurance

In the medical device testing industry, a Tester de puncție cu ac, or Medical Needle Puncture Tester, is indispensable for maintaining stringent quality standards. These testers evaluate the puncture resistance of various materials, ensuring they can withstand needle penetration without compromising integrity. The Needle Puncture Tester from MaterialTests.com is a prime example of advanced equipment designed for precise needle puncture testing.

Product Description: The Tester de puncție cu ac can be equipped with multiple types of needles and different sample holding jigs. Its professional program meets the demands of needle puncture testing across various materials, ensuring compliance with industry standards like ASTM F2878 and EN 388. This tester is essential for conducting tests on hypodermic needles, artificial skin, rubber stoppers, protective gloves, clothing, medical closures, infusion bag films, and more. It guarantees the safety, reliability, and performance of these products by accurately measuring their puncture resistance.

Specific Applications and Testing Standards

For applications like needle puncture resistance test for rubber stopper și vial stopper, as well as penetrability test for rubber stopper și vial stopper, these tests are crucial. They ensure that stoppers used in pharmaceutical packaging provide adequate protection against accidental punctures while allowing syringes to penetrate smoothly when necessary. Similarly, syringe needle puncture tester și medical needle penetrability testing help in evaluating the ease and consistency with which a needle can penetrate a stopper without causing damage or contamination.

Compliance with Industry Standards

Compliance with standards such as ISO 7864 ensures that all tested products adhere to strict guidelines, guaranteeing their effectiveness and safety. The tester de penetrare cu ace utilizate pentru aceste evaluări trebuie să fie în conformitate cu metodele stabilite în documente precum ASTM F2878 și EN 388. Acestea includ Metoda de testare a penetrării acului protocoale pentru ace hipodermice și seringi, care sunt concepute pentru a simula condițiile din lumea reală.

Advanced Features and Benefits of the NPT-01 Needle Puncture Tester

The  Tester de puncție cu ac offers several advanced features that enhance its functionality and accuracy:

1. PLC Control Unit and HMI Touch Screen: Equipped with a PLC control unit and an intuitive 7-inch HMI touch screen, ensuring easy operation and efficient control.
2. Precision Ball Screw and Stepper Motor Technology: Ensures precise and consistent testing results, maintaining accuracy throughout the process.
3. Variable Test Speed Capability: Provides flexibility, allowing users to adjust testing speeds according to specific requirements and sample types.
4. Range of Sample Jigs and Needle Types: Catering to diverse testing needs and applications.
5. Caracteristici de siguranță: Incorporates position restrictors and overload protections to ensure operator safety and equipment integrity during testing operations.
6. Automatic Return Function: After completing a test, the tester automatically returns to its initial position, saving valuable operation time and streamlining the testing process.
7. Long-Term Data Keeping: Embedded with a dot matrix type microprinter, facilitating detailed records of testing results for analysis and reference purposes.

Aplicații practice și studii de caz

To illustrate the importance of needle puncture resistance testing, consider the following scenarios:

• Pharmaceutical Packaging: Ensuring that rubber stoppers used in vials can withstand repeated punctures by needles without tearing or fragmenting is vital for maintaining drug purity and efficacy.
• Medical Devices: Hypodermic needles must penetrate skin efficiently and safely, minimizing patient discomfort and risk of injury. Testing with the  Tester de puncție cu ac helps manufacturers design and produce needles that meet these stringent requirements.
• Protective Gear: Evaluating the puncture resistance of materials used in protective gloves and clothing is crucial for healthcare workers who handle sharp objects daily. Reliable testing ensures that these materials offer sufficient protection without hindering mobility or dexterity.

Concluzie

In conclusion, adhering to ISO 7864 and utilizing reliable testere de puncție a acului is indispensable for manufacturers in the medical and pharmaceutical sectors. Ensuring that products meet stringent quality and safety criteria helps protect patients and healthcare providers alike. By investing in high-quality mașini de testare a penetrării acelor medicale, companies can enhance product performance, comply with regulatory requirements, and foster consumer trust. The  Tester de puncție cu ac se remarcă ca un instrument robust și versatil, oferind precizie, flexibilitate și capacități complete de înregistrare a datelor pentru a susține protocoale de testare riguroase.