Certification of extension tubes for medical use according to TIS 2385-2551

Abstract

The extension tube is a medical device for delivering substances into or out of the body through blood vessels of the patient. To ensure the safety of users and promote the domestic production, the industrial product standard of extension tubes was established as Thai Industrial Standard (TIS) No. 2385-2551: Extension tubes for medical use. Bever Medical Industry (BMI) is a medical device company that manufactures and markets medical supplies for single use. At present, the overall physical requirements standard of extension tubes has not been accredited according to ISO/IEC 17025. This study aims to certify the physical test of extension tubes for medical use and to implement the laboratory quality management system according to ISO/IEC 17025. We set up a laboratory to perform the physical test of extension tubes according to TIS 2385-2551. The measuring equipment was applied appropriately and calibrated by accredited laboratories to ISO/IEC17025 related to metrological traceability. The established laboratory performed the evaluation of measurement uncertainty for some testing and reported the results to the customer as a test certification report. In this study, a total of 1.75 million pieces of extension tubes have been certified the quality improvements. Therefore, it is valuable for entrepreneurs, importers, and exporters in both domestic and international markets.