Literature DB >> 11185190

Preclinical evaluation of medical devices.

L S Bollen1.   

Abstract

Biological evaluation should be performed as part of risk assessment of the device. It can help define the toxicity and compatibility of the device. This article outlines which tests should be performed, with some examples of specific device test regimes.

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Year:  2000        PMID： 11185190

Source DB:  PubMed          Journal:  Med Device Technol        ISSN： 1048-6690


  1 in total

1.  Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products.

Authors:  Herbert Fink; Nuno M de Barros Fernandes; Jörg Weissmann; Manfred Frey
Journal:  J Diabetes Sci Technol       Date:  2020-03-01
  1 in total

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