Biological Properties of Medical Devices
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Date
2011-02-07
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Bulletin of the Department of Medical Sciences - วารสารกรมวิทยาศาสตร์การแพทย์
Abstract
During BE.2548 to BE.2550 test for biological properties of medical devices i.e. surgical gloves, sterile hypodermic syringes for single-use, sterile single-use syringes for insulin, sterile blood transfusion sets for single-use, infusion for single-use, feeding catheter for single-use, suction catheter for single-use and sterile hypodermic needle for single-use in the respiratory tract, totally 434 samples, were performed. The sterility, the safety and the pyrogen tests were carried out following the requirements in the Notification of the Ministry of Public Health (No.14-16 BE. 2537), TIS .720-2546 TIS.1426-2546, TIS.1050-2547, TIS.1394-2548 and TIS.1398-2540. The results showed that 1 out of 226 samples of the surgical gloves, 1 out of 38 samples of the hypodermic syringes for single-use, 1 out of 5 samples of sterile blood transfusion sets, 1 out of 30 samples of feeding catheter for single-use and 1 out of 66 samples of catheter for single-use did not pass the sterility test, while 15 samples of sterile single-use syringes for insulin, 4 samples of infusion for single-use and 50 samples of sterile hypodermic needle for sing-use passed all of the test.Key words : Medical devices
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Citation
Bulletin of the Department of Medical Sciences - วารสารกรมวิทยาศาสตร์การแพทย์; Vol.51 No.2 April - June 2009; 113-127