Medical Device Testing

BSL BIOSERVICE offers biocompatibility testing for medical devices according to ISO 10993.

In order to replace, reduce and refine (3 Rs) the use of animals in medical device testing, BSL BIOSERVICE together with its partner Eurofins BioPharma Prodcut Testing Munich offers you a device based testing strategy which meets your regulatory needs.

When animal testing is needed, the procedures involving living animals are carefully evaluated in order to combine end points in one central study when feasible. 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.

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

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 selected breeders. All experimental protocols are reviewed by BSL internal ethical committee and accepted by governmental competent authority. The studies are monitored by an independent animal welfare officer.

Species

• Rat
• Guinea Pig
• 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
• Ocular implants
• Dental 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)

Test Specifications

• 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.

• 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