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Significance of Metrological Tools in an ISO 17025 Accredited Quality System for a Biological Evaluation Facility

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Abstract

Maintaining a biological evaluation facility with reliability and acceptance is one of the critical issues in the field of medical device development. Establishing metrological traceability in the biological evaluation is a complex process when compared to the traceability in technical and industrial calibration and testing. In the development of medical devices, the risk of biocompatibility of biomaterials caused by chemical toxicity, physical characteristics like surface properties, presence of particulates, forces on surrounding tissue that might contribute to an unwanted tissue response, etc. has to be evaluated for their safe use. In a biological evaluation facility when reliability in test results and performance of the medical device are required for assuring patient safety, due considerations are to be given to testing and traceable calibration of associated equipment. Evidence for an established traceability chain through the use of metrological tools is one of the essential requirements for getting regulatory approval also. Therefore, regular conduct of calibrations and use of Reference Materials (RMs) in a biological evaluation facility is of utmost importance owing to the safety of patients. For the above reasons, this article will give a clear picture of the role of an accredited metrological system in the biological evaluation of materials and medical devices.

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Acknowledgements

Authors would like to acknowledge TRC scheme of SCTIMST under Dept. of Science and Technology, Govt. of India for providing opportunity and facilities in establishing a RM facility.

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Department of Science and Technology, Ministry of Science and Technology, TRC, Leena Joseph.

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Authors and Affiliations

  1. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India

    Leena Joseph, P. Ramesh, N. S. Remya, V. Arumugham & R. P. Rajesh

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  1. Leena Joseph
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  2. P. Ramesh
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  3. N. S. Remya
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  4. V. Arumugham
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  5. R. P. Rajesh
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Correspondence to Leena Joseph.

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Joseph, L., Ramesh, P., Remya, N.S. et al. Significance of Metrological Tools in an ISO 17025 Accredited Quality System for a Biological Evaluation Facility. MAPAN 37, 683–691 (2022). https://doi.org/10.1007/s12647-021-00517-2

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