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Local effects after implantation of medical device

Aim:

Assessment of biological safety (biocompatibility) after implantation of the biomaterial intended for use in medical devices or finale product. Materials can be solid and non-biodegradable, degradable and/or resorbable, or non-solid (e.g. porous materials, liquids, gels/pastes and particulates). Relevant guidelines: ISO 10993-6 and USP88.

Test System:

  • Rabbit (USP88)
  • Mice, rats, hamsters or rabbit (ISO 10993-6) preferred
  • Rabbits, dogs, pigs/minipigs, sheep, goats when implantation at the site of clinical use

Design:

The test item/medical device is implanted on the right side of animal. The reference material/formulation is implanted on the left side of each animal. At defined time points mortality, clinical signs and body weight are recorded. Macroscopical evaluation, scoring of the implants and the implantation site and photomicrography of adverse findings complete the monitoring.

Outcome:

Assessment of the behavior of the medical device with respect to possible disintegration / changes of surface condition and degree of biodegradation.

Comparative evaluation of local effects after implantation in terms of biological response to medical device/test material vs. reference material including identification of exaggerated biological response and adverse effects.

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