Medical Device Stability & Shelf-Life Studies

At Bio-Standards, we focus on the stability and shelf life of medical devices to ensure their long term safety and regulatory compliance. Our thorough assessment process includes the following key testing protocols:

Our comprehensive assessment ensures that your medical devices and IVDs maintain quality, sterility, and functionality throughout their intended lifecycle, supporting successful market access in Saudi Arabia and GCC markets.

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1. Transport Simulation Testing:
   Our evaluation of the transport simulation testing methods is in accordance with ASTM D4169 to replicate mechanical and environmental stresses during distribution. This includes:
   
   • Vibration
   • Drop
   • Compression
   • Vacuum conditions

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2. Packaging Integrity Testing:
   Our evaluation of packaging systems adheres to EN ISO 11607 standards, focusing on both physical and microbiological integrity. Testing methods include:
   
   • Tensile strength (ASTM F88)
   • Visual inspection (ASTM F1886)
   • Burst testing (ASTM F1140, ASTM F2054)
   • Dye penetration leak testing (ASTM F1929)

These evaluations confirm that packaging maintains sterility, durability, and compliance throughout storage and distribution.

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3. Accelerated and Real-Time Aging Testing:
   To determine shelf life and sterile barrier performance, we evaluate the protocol of the conducted aging studies in line with ASTM F1980. This involves:
   
   • Temperature and humidity-controlled storage
   • Stability protocols tailored to product-specific material characteristics
   • Statistical justification for sample selection to ensure representativeness

These studies support shelf-life claims, ensuring compliance with SFDA requirements and international regulatory submissions.

Partner with Bio-Standards to validate the stability and shelf life of your medical devices with confidence.