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Medical device manufacturers now have access to a cutting-edge resilience testing solution specifically engineered for blood collection needle rubber sleeves. This innovative system ensures critical sealing performance through precise measurement of post-compression dimensional recovery, addressing FDA Quality System Regulation (QSR) requirements while enhancing patient safety.
The tester adheres to stringent international standards including ISO 80369 (needle dimensions), ISO 11040 (hypodermic needle caps), and ISO 7886 (injection systems). Its advanced laser displacement sensor, with ±0.01mm accuracy, guarantees reliable data collection during rigorous testing protocols. The system offers adjustable compression force from 5-50N and deflection testing up to 50% of sleeve diameter, with programmable cycles from 1 to 10,000 repetitions.
Powered by a pneumatic actuation system, the tester simulates clinical insertion forces by compressing sleeves between parallel plates. Real-time dimensional analysis via high-resolution imaging and force monitoring enables comprehensive fatigue assessment. Proprietary algorithms calculate resilience as percentage recovery from compressed states, providing actionable material optimization insights.
The system performs three critical assessments:
This integrated solution empowers manufacturers to develop next-generation needle sleeves with superior sealing characteristics, ensuring compliance with global medical device standards. For more information on optimizing your production line with this breakthrough technology, contact our technical team today.
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