Biological Evaluation is a series of tests performed pre-clinically either through invitro or in-vivo techniques to assess the biological safety of the device. When the medical device comes in contact with the body, it should be assessed for its safety upon use. The biological evaluation shall be planned, carried out and documented by knowledgeable and experienced individuals capable of making informed decisions based on the advantages and disadvantages of the materials and various test procedures available. Biological evaluation has been assessed based on the contact duration, contact site of material and the device through various in-vitro and in-vivo techniques. Biological evaluation can be carried out as per the harmonised standard EN ISO 10993-1:2009/AC: 2010 within a risk management process in accordance with ISO 14971:2007.
The Main factors to be considered for biological evaluation are:
- Material of Manufacture
- Components of the device
- Components contacting the device
- Literature evidence on the safety of the material
- Literature evidence on the safety of the device
- Pre-clinical data on the equivalent device
- Risks of the device
In the selection of materials to be used in the medical device shall consider characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.
Selection Criteria of Biological Evaluation Teat for Medical Devices:
Medical devices shall be categorized according to the nature and duration of body contact, and by considering these points the selection of appropriate biological tests can be possible.
Nature of Contact:
- Non-contacting medical devices- These include medical devices that have neither direct nor indirect contact with the body and where biocompatibility information would not be necessary.
- Surface-contacting medical devices
- Externally communicating medical devices
- Implant medical devices
Duration of contact
- Limited exposure (A) – medical devices whose cumulative sum of single, multiple or repeated duration of contact is up to 24 h.
- Prolonged exposure (B) – medical devices whose cumulative sum of single, multiple or repeated contact time is likely to exceed 24 h but not exceed 30 d.
- Long-term exposure (C) – medical devices whose cumulative sum of single, multiple or repeated contact time exceeds 30 d.
Below flowchart explains the systematic approach to a biological evaluation of medical device:
* Annex A of EN ISO 10993-1 indicates the Endpoints to be addressed in a biological risk assessment.
EN ISO 10993-1:2009/AC: 2010, ISO 10993-1:2018
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