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Nonclinical Safety Evaluation of Medical Devices
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
Kathleen A. Funk, Victoria A. Hampshire, JoAnn C. L. Schuh
Cytotoxicity testing is the analysis of extracts from the device materials derived from the device in its ready-to-use form, including the sterilization, packaging, and handling procedures for the device as it is intended for clinical use. Multicomponent devices generally require testing of materials in direct contact with the body (catheter tip), indirect contact (intravenous tubing), and remote contact (testing of the headspace in polymer-based intravenous bag). Cytotoxicity (ISO 10993-5:2009) measured by cytolysis, inhibited cell growth, colony formation, or other cellular effects in vitro, is a common point of materials and manufacturing/processing failure and the cause may remain unidentified.
Stem Cells and Nanotechnology
Published in Stavros Hatzopoulos, Andrea Ciorba, Mark Krumm, Advances in Audiology and Hearing Science, 2020
The definition of biocompatibility currently included in ISO 10993-1 (2016), “the ability of a device material to perform with an appropriate host response in a specific situation,” is still similar to that referred to first-generation biomaterials.
Biomedical Devices: Overview
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” Retrieved October 28, 2011, from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm.
Occlusion of the cystic duct with cyanoacrylate glue at laparoscopic subtotal fenestrating cholecystectomy for a difficult gallbladder
Published in Acta Chirurgica Belgica, 2022
Deborah C. Jenner, Michail Klimovskij, Michael Nicholls, Tom Bates
Given that glue was being used to occlude the cystic duct at primary laparoscopic cholecystectomy, rather than in the treatment of a postoperative biliary fistula [5], this was an innovative procedure. However, from a safety aspect cyanoacrylate glue has been used intra-abdominally at multiple sites over an extended period without evidence of toxicity. In 2012 Kukleta et al. reported the use of n-butyl cyanoacrylate (NBCA) glue for the preperitoneal fixation of meshes for the laparoscopic TAPP repair of 1300 inguinal hernias which was clinically effective and safe. Further standardised tests for sensitisation, genotoxicity and biocompatibility proved satisfactory and safe which also met the standard requirements of ISO 10993 for medical devices [17]. NBCA glue has also been used intraperitoneally. The glue has been sprayed on the liver to facilitate laparoscopic access for upper abdominal surgery in 50 cases which caused transient minor changes of liver function tests [18]. There have been many reports on the use NBCA glue for postoperative biliary leakage since 2002 [4], mostly delivered at ERCP, but patient safety has not been in issue.
Compatibility and durability of the gel stent material
Published in Expert Review of Medical Devices, 2022
Vanessa Vera, Arsham Sheybani, William Wustenberg, Laszlo Romoda, Larissa Camejo, Xiongfei Liu, Richard Lewis
A variety of biocompatibility tests were performed to characterize the long-term and short-term profile of the stent. This preclinical testing was conducted in compliance with International Standard ISO 10993–1 [11]; the standardized biological evaluation of medical devices, including the evaluation and testing within a risk management process. This guides the classification of a device according to how it is in contact with a patient, what the potential risks are, what testing is necessary, and the results of those assays demonstrated that the materials were appropriate and would not show adverse effects.