時間: 人気:0タイムズ
In the critical medical device sector, ensuring catheter integrity under repetitive clinical use is non-negotiable. Introducing our state-of-the-art Catheter Durability Tester—engineered to replicate real-world physiological stresses and deliver actionable insights for manufacturers seeking ISO-compliant, high-performance designs.
✅ ISO-Aligned Expertise: Preconfigured for ISO 80369 (connector integrity), ISO 1135 (syringe safety), and ISO 10993 (biocompatibility), our system ensures seamless compliance with global medical standards.
✅ FDA Readiness: Built to support FDA 21 CFR Part 820 quality mandates, our tester helps manufacturers validate device longevity and safety before market launch.
✅ Patient-Centric Innovation: By simulating dynamic bending (0-180° ±0.1°), kink resistance, and fatigue cycles (10-60 cycles/min), we empower engineers to design catheters that withstand clinical rigors—enhancing patient outcomes.
🔍 Smart Simulation: Servo-driven actuators replicate in-vivo motion patterns while thermal chambers maintain 37°C conditions, mimicking real-time physiological environments.
📊 Data-Driven Insights: Advanced sensors capture force-displacement curves and failure modes, paired with AI algorithms that predict material degradation. Programmable test durations (1–10.000 cycles) cater to diverse R&D needs.
🔧 Adaptive Testing: Adjustable fixtures accommodate various catheter sizes and geometries, streamlining testing across product lines.
Our integrated solution doesn’t just identify weaknesses—it drives innovation. By evaluating dynamic bending, static kinking, and cyclic fatigue, manufacturers can:
Reduce recalls: Validate designs against real-world failure modes.
Accelerate time-to-market: Consolidate testing phases with automated data analysis.
Elevate brand trust: Demonstrate commitment to patient safety through rigorous mechanical characterization.
Contact our team today to explore how our tester can transform your R&D workflow. From startups to global OEMs, we deliver precision, compliance, and peace of mind.
🔗 Learn More | Request a Demo | Customize Your Testing Protocol
Your journey to best-in-class catheter durability starts here.
SEO Keywords: Catheter durability testing, medical device compliance, ISO catheter standards, FDA 21 CFR Part 820. biomechanical simulation, catheter fatigue testing.
会社電話
+86-21-6420 0566
営業時間
月曜日から金曜日
携帯電話:
13816217984
メール:
info@qinsun-lab.com