Syringes are essential medical devices used for drug administration, requiring precise and reliable performance. A syringe leak tester ensures the integrity of the plunger stopper seal, preventing air leakage that could compromise medication delivery. Without proper testing, air bubbles may form within the syringe, leading to inaccurate dosing or serious medical complications.
Introdução
Syringes are essential medical devices used for drug administration, requiring precise and reliable performance. A syringe leak tester ensures the integrity of the plunger stopper seal, preventing air leakage that could compromise medication delivery. Without proper testing, air bubbles may form within the syringe, leading to inaccurate dosing or serious medical complications.
Why Choose a Syringe Leak Tester?
1. Ensures Medication Accuracy
By detecting air leaks, a syringe leak tester guarantees accurate medication dosing, reducing risks associated with air embolism or incorrect injection volume.
2. Prevents Syringe Failures
Plunger stopper detachment can render a syringe unusable. Proper testing prevents failures that could lead to incomplete or unsafe medication administration.
3. Ensures Compliance with Industry Standards
Regulatory compliance with Norma ISO 7886-1 is critical for medical device manufacturers. Using an ISO-compliant syringe leak tester ensures adherence to quality and safety standards.
4. Enhances Patient Safety
Reliable syringe performance minimizes risks for both healthcare professionals and patients, ensuring safe and effective drug delivery.
Padrão
Compliance with ISO 7886-1
Norma ISO 7886-1 specifies the test methods for single-use hypodermic syringes, ensuring their reliability and safety. The standard includes:
- Air leakage test: Evaluates the syringe’s ability to maintain a vacuum without air passing through the plunger stopper.
- Plunger stopper retention test: Determines whether the stopper remains securely attached to the plunger during aspiration.
Key Requirements from ISO 7886-1 Annex B
According to Annex B of ISO 7886-1, the leak test involves:
- Filling the syringe with at least 25% of its nominal capacity using distilled water.
- Applying vacuum pressure of 88 kPa below atmospheric pressure.
- Observing air leakage past the plunger stopper and monitoring vacuum retention for 60 seconds.
- Determining plunger stopper detachment, if any.
Working Principle
A syringe leak tester operates by creating a controlled vacuum within the syringe while monitoring pressure stability. The SLT-02 Syringe Leak Tester, for example, utilizes:
Principais especificações técnicas
| Faixa de teste | 0~-90 kPa |
| Air Input | 0.6~0.7 MPa |
| Hora do teste | Up to 9999 hours |
| Poder | 110~220V 50/60Hz |
Padrão: LT-02 Leak Tester control unit, Syringe Stand, Tube, power cord, fuse.
Opcional: Software, customized sample fixture size
Características técnicas
Perguntas frequentes
1. What is a syringe leak tester used for?
A syringe leak tester is used to detect air leakage and ensure the plunger stopper remains intact during aspiration, maintaining syringe reliability.
2. Why is compliance with ISO 7886-1 important?
ISO 7886-1 sets the standard for single-use hypodermic syringes, ensuring safety, accuracy, and performance consistency.
3. How does the SLT-02 Syringe Leak Tester work?
The SLT-02 applies a controlled vacuum to the syringe, monitoring pressure changes to detect air leakage and plunger detachment.
4. What are the main technical features of the SLT-02 Syringe Leak Tester?
Key features include stable vacuum holding, efficient vacuum generation, adjustable fixtures, and automated operation.
5. Who should use a syringe leak tester?
Medical device manufacturers, quality control personnel, and pharmaceutical companies should use a syringe leak tester to ensure compliance and product reliability.
A syringe leak tester is a vital instrument for ensuring the integrity of medical syringes. Compliance with Norma ISO 7886-1 ensures that syringes maintain a secure seal, preventing air leakage and plunger detachment. The SLT-02 Syringe Leak Tester from Instrumentos de Célula offers precise and reliable testing solutions for medical and pharmaceutical industries, guaranteeing the highest standards of safety and quality.
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