Medical Device BiocompatibilityĀ depends on device risk class and each risk the test procedures according to ISO 10993-1 must be selected.
Assessing the safety of a medical device under the patient condition and manufactures indication is important and leads to biological evaluation so called bio-compatibility.
To evaluate the biological safety of medical device prior to launch is a must? Is it a part of my design validation?
The selection of materials plays a important role in the evaluating the biological safety. The material selection and risk analysis are considered as integral components of the design
process for medical devices. As per ISO 14971, risk management activities must be planned in advance. The biological evaluation is considered as a part of risk management activity and hence it is required to evaluate the biological safety of the medical device, considering the intended application of device, during the design and development process. And also the manufacturer should evaluate the biological safety of a medical device over the whole life-cycle.
Biocompatibility testing of materials is considered as a part of verification and the clinical evaluation or performance evaluation of the medical device considered as a part of validation, during the design and development process.
The aim of Biological Evaluation of medical devices as per ISO 10993-1 is to protect humans from potential biological hazards such as genotoxicity, carcinogenicity, haemotoxicity, etc., arising from device-tissue interaction. Therefore, it is mandatory to evaluate the biological safety of a medical device by a manufacturer prior to its launch, mainly to understand and mitigate such biological hazards due to the device.
No, it is not a part of the design validation. The ISO 10993-1:2018 clearly states in its introduction that Biological Evaluation is part of the ādesign verificationā, which is set in the context of risk management processes conducted according to the requirements of ISO 14971.