Medical Devices need to assess the biocompatibility of their medical device materials and processes by taking a risk-based approach to their biological safety evaluations.
The main objective of biocompatibility testing is the protection of man against potential biological hazards by the use of medical devices through a biological evaluation, compilation of historical data, and reference tests. This allows to perform a comprehensive assessment of biological responses for each medical device in relation to its safety.
The term "medical device" goes from simple component to complex instrument of many components and materials.
The tests required to verify biocompatibility differ by type of device (surface contact, implantable), type of contact (skin, mucous membrane, wound area, tissue, bone, dentine, bloodstream, blood...), the contact time (limited, prolonged or permanent) and the historical data existing on the material used.
Biocompatibility Testing can be divided into the following three steps:
- Risk Identification (Biological Evaluation Plan)
- Risk Mitigation through testing (Biological evaluation of your medical device)
- Evaluation of results (Biological Evaluation Report)
Risk Identification (Biological Evaluation Plan)
ISO 10993 states that “The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.” Our laboratory takes into consideration the materials, processing, and historical use of the device. This allows to perform a comprehensive assessment of biological responses for each medical device concerning its safety.
Our team will help you thoroughly assess the following key data points:
- What are the clinical use of the product?
- What are the types of dermal contact? (tract, muscle-invasive, bone, bloodstream…)
- Is degradation expected?
- What is the dermal contact time
- What are the compositions of the materials forming the medical device?
- Can we define representative portions of the medical device that are in contact with the patient or with the liquid that’s in contact with the patient?
- Is there any historical data on the biocompatibility/ materials/ according to their categorisation?
Risk Mitigation through testing (Biological evaluation of your medical device)
The biocompatibility tests reflect up to 8 different biological effects (themselves divided into different targeted tests). The type of test to be performed among the eight categories is closely related to the use of the medical device. The choice between different tests, and critical aspects in duration (eg tests implantation) should be discussed with the competent authorities (Swissmedic , FDA, TUV…)
- Irritation or intradermal reaction
- Acute Systemic Toxicity
- Subacute Systemic Toxicity
Contract Sterilisation Services
Medistri’s sterilisation infrastructure was engineered to allow you to save time and distribute your products on the market faster. We have optimised our sterilisation processes to provide you with the fastest sterilisation services available to date.
Our Quality Certificates
Explore our list quality certificates and discover why the world's most innovative healthcare companies choose to work with Medistri.
We’ve designed our company’s laboratory and sterilisation units to be working hand in hand with our quality team, under one roof, at all times. Learn more about our history and mission.
Are you ready to get started?
Contact us and our qualified team will respond.