Biocompatibility Testing for Medical Devices.

Complex 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.

Biocompatibility Testing can be divided into the following three steps:

1) Risk Identification (Biological Evaluation Plan)
2) Risk Mitigation through testing (Biological evaluation of your medical device)
3) 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 in relation to 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…)

- Cytotoxicity
- Sensitisation
- Irritation or intradermal reaction
- Acute Systemic Toxicity
- Subacute Systemic Toxicity
- Genotoxicity
- Haemocompatibility

👉 The final Biological Evaluation Report is created according to ISO 10993–1:2018

By working with Medistri you are joining a growing number of innovative healthcare companies that are using Medistri’s Biocompatibility testing performed according to: Iso 10993.

- The Medistri Team

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