BS EN ISO 10993-11:2009 pdf free download.Biological evaluation of medical devices -Part11:Tests for systemic toxicity. Systemic toxicity is a potential adverse effect of the use of medical devices. Generalized effects, as well as organ and organ system effects can result from absorption, distribution and metabolism of leachates from the device or its materials to parts of the body with which...
BS EN ISO 10993-18:2009 pdf free download
ISO 10993-1 provides a framework for a structured programme of assessment for the evaluation of biological safety. Clause 3 of ISO 10993-1:2003 states that in the selection of materials to be used for device manufacture the first consideration should be fitness for purpose. This should have regard to the characteristics and properties of the material, which include chemical, toxicological, physical,...
DIN EN ISO 10993-18:2009 pdf
DIN EN ISO 10993-18:2009 pdf.Biological Evaluation Of Medical Devices - Part 18: Chemical Characterization Of Materials (ISO 10993-18:2005); German Version EN ISO 10993-18:2009 1 Anwendungsbereich Dieses Dokument Iegt einen Rahmen für die Ermittlung biologischer Gelährdungen und für die Abschätzung und Beherrschung der von Bestandteilwerkstoffen ausgehenden biologischen Risiken unter Anwendung eines schrittweisen Ansatzes für die Charakterisierung eines Medizinprodukts durch Folgendes lest:...
BS EN ISO 10993-10:2013 pdf
BS EN ISO 10993-10:2013 pdf.Biological Evaluation Of Medical Devices - Part10:Tests For Irritation And Skin Sensitization. This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and...