Biological Evaluation is performed to measure the compatibility of a material with a biological system. The evaluation is performed using a series of tests as per a standard corresponding to the type of product for example pharmaceuticals, cosmetics and medical devices to demonstrate that the material or device will not cause any potential risks to humans during the course of its use.
Biological Evaluation Report
The Biological Evaluation Report is a collective summary of all biological tests performed and justifications for tests not performed.
That includes supporting data from the literature, assessment of data, gap analysis for already available information for biological safety, rationale for why additional information isn’t needed and a statement confirming the biological risk analysis and risk controls that have been completed. The report is used to demonstrate that a medical device will not cause any potential risks to patients and intended users during the course of its use.
Biological Evaluation Of Medical Devices
Biological Evaluation of Medical Devices is a series of tests performed with the help of international standards by pre-clinically either through in-vitro or in-vivo techniques and may upon animal models to assess the biological safety of the medical device within risk management process.
EN ISO 10993-1:2009/AC:2010 gives guidance on the tests required to prove the biological safety of the medical device based on its nature and duration of contact.
The primary goal of the biological evaluation of medical devices is to protect the patient from the biological risk raised from the medical device.
Biological Evaluation Plan
A Biological Evaluation Plan is used to prove the safety of the device by demonstrating compliance to corresponding standards and avoiding unnecessary testing of the device.
Since biological evaluation is a risk management activity, a Biological Evaluation Plan is required, and this forms part of the Risk Management Plan.
The biological evaluation plan not only emphasizes on the biocompatibility tests but the requirements of ISO 14971 risk management. The biological evaluation plan should be drawn up by a knowledgeable and experienced team and that include:
- arrangements for gathering of applicable information from the published literature
- arrangements for review and approval of the plan as part of the overall design control process
- arrangements for review of the final conclusions of the evaluation and the approval of any additional testing required
- arrangements for the final review and approval of the outcomes of the biological risk assessment
Factors considered during Biological Evaluation Plan
A biological evaluation plan includes the characterization of medical devices and the identification of tests based on those characteristics. The characterization of the medical device include:
A. Nature of body contact:
- Surface contacting device
- Externally communicating device
- Implant device
- Non contacting device
B. Duration of contact
- Limited exposure
- Prolonged exposure
- Long-term exposure
C. Material Characterization (The type of material, end use of the device and function of material within the device are considered in this step)
D. Chemical and Physical Characterization (types and amounts of chemicals that may migrate from a device to a patient during its use, to predict potential toxicities and the risk factors associated with using a device)
E. Data regarding existing toxicology and other biological safety data (review both existing clinical and pre-clinical data and the testing is usually not necessary when sufficient information is already available.)
F. Packaging materials that directly or indirectly contact the medical device and chemical transfer.
G. Leachable substances
H. Degradation products
Identification of test based on end point selection as per Annex A of ISO 10993-I according to their nature of body contact, duration of contact.
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