Stability study of medical devices

Medical Device Stability Testing is conducted to determine the environmental effects such as temperature, light, moisture, pH, agitation, gravity on product strength, quality, and purity. Such testing’s are conducted in the life sciences, chemical, medical devices, IVDs, pharmaceuticals, and food industries. Stability testing provide evidence to establish product storage and expiry dating criteria.

The medical devices stability testing determines the extent to which a device holds-on, within specified limits, and throughout its period of storage and use, the same properties, and characteristics that it possessed at its time of manufacture. Similar to pharmaceutical products, medical devices have a set of criteria to evaluate stability such as:

  • Chemical – Degradation, Interaction, Device packaging and interaction, Radioactive decay, Manufacturing
  • Physical – Physical characteristics, Manufacturing process, Storage conditions
  • Microbiological – Sterility, Environmental control, Antimicrobial effectiveness
  • Therapeutic
  • Toxicological
  • Biocompatibility

References

  • MDRF – Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
  • ICH guideline Q series

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