more than 30 years of experience in biological safety testing

Implantation Testing according to ISO 10993

According to ISO 10993-6 the local effects after implantation of biomaterials intended for long-term implantation periods in man have to be demonstrated.

As recommended by ISO 10993, systemic toxicity and local tolerance end points can be combined in one single experiment to fulfill the requirements of ISO 10993-6 and 10993-11 and adhere to the 3R principles guiding the ethical use of animals in safety evaluations.

Dependent on the size and the intended use of the implant material, larger animals than rats need to be used.

The suitable surgical implantation method as well as the selection of the appropriate animal species is the most important prerequisites of a successful animal study.

BSL BIOSERVICE has long-term experience with GLP compliant in vivo studies for medical devices. The facility is AAALAC and ISO accredited. A well trained staff of experienced veterinarians, surgeons and animal care keepers is responsible for the conduction of high quality implantation studies. Animals chosen are only from selsected breeders. All experimental protocols are reviewed by BSL internal ethical committee and accepted by governmental competent authority. The studies ar monitored by an independent animal welfare officer.

Species

  • Rabbit
  • Sheep
  • Pig / Mini Pig

Animal studies for different kinds of implants are available

  • Orthopedic Implants
  • Osteoinductive Materials
  • Drug Application Systems
  • Tissue Engineering Products
  • Cardiovascular Implants

Implants exist in various forms that require individual test designs:

  • Solid Implant Types made from
    - Metals
    - Polymers
    - Ceramics
  • Pastes
  • Two Part Systems
    (to be mixed in situ before implantation)

Our scientists take into consideration the type of implant, its intended use, as well as its duration of patient contact and develop customized non-clinical programs for these products.

Test Specifications

  • Individual developed surgical equipment and techniques
  • Definition of the most adequate control material
  • Evaluation of tissue response by histology (in cooperation with Anapath)
    up to final integration or resorption/degradation of the material
  • Examination of:
    - Fracture repairs
    - Long bone defect repair
    - Cortical, cranial, trabecullar, maxillofacial defects
    - Orthopedic prosthetic infection

Additional Tests for longer term or Lifetime Implants

  • Chronic systemic implant testing
  • Functional orthopedic testing