Medical Syringe and Needle Tester – QualiMed™ - MSNT is a comprehensive, benchtop testing system engineered to evaluate the mechanical performance, safety, and functional reliability of medical syringes and needles. Designed to support regulatory compliance and quality assurance, this medical syringe and needle tester integrates multiple test programs into a single modular platform.

Using precision force and displacement control, the system measures critical parameters such as break-loose force, glide force, leakage resistance, needle penetration, and bonding strength. By consolidating these test capabilities, the QualiMed™ - MSNT enables manufacturers and testing laboratories to verify product integrity, improve consistency, and reduce the risk of clinical failure throughout production and validation processes.

Medical Syringe and Needle Tester – QualiMed™ - MSNT Applications

The Medical Syringe and Needle Tester – QualiMed™ - MSNT is widely used for compliance testing, R&D, and quality control in accordance with international pharmacopeia and medical device standards, including:

Standard	Test Description	Test Program
ISO 7886-1, Annex D	Liquid leakage at the syringe plunger stopper under compression conditions	Program D
ISO 7886-1, Annex E / ISO 11499	Force required to operate the syringe piston during use	Program A
USP <381>, USP <382>, ISO 8871-5 Annex A, ISO 11040-4	Needle penetration resistance and needle breakage performance testing	Program B
ISO 7864, Annex D	Measurement of needle penetration force and drag force during insertion	Program C
ISO 7886-1, Annex D	Verification of plunger stopper sealing performance under applied compression	Program D
ISO 9626 / ISO 11608-3 / ISO 11040-2	Tubing stiffness evaluation and leakage integrity testing	Program E
ISO 11608-2	Needle bonding strength and connection integrity testing	Program F

Standards:

ISO 7886-1 – Sterile hypodermic syringes for single use (mechanical performance, leakage, piston operation).
ISO 7864 – Sterile hypodermic needles for single use (penetration force, bonding strength, and performance).
ISO 9626 – Stainless steel needle tubing for the manufacture of medical devices (dimensions and mechanical properties).
ISO 11040-2 – Prefilled syringes for injectables (needle attachment and syringe component performance).
ISO 11608-2 – Needle-based injection systems (needle performance and attachment integrity).
USP <381> – Elastomeric closures for injections (functional performance and sealing integrity of syringe components).