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Medical Device Software Verification, Validation, and Compliance
David A. Vogel
Limited preview - 2010
30 days and/or their extracts Animal welfare Annex Biodegradation biological evaluation tests biological response blood path Breached or compromised Carcinogenicity catheters caused by medical cell Chronic toxicity Circulating blood compromised surface considered Cytotoxicity degradation products dental described in ISO devices and materials devices in contact devices or materials devices principally contacting devices that contact devices These include devices whose single duration category duration of contact duration of exposure evaluation of medical exposure or contact External communicating device final product Genotoxicity Haemolysis humans Identification and quantification Implant device include medical devices Initial evaluation tests intended International Standards Intracutaneous reactivity irritation materials and/or member bodies Mucosal membrane multiple exposures potential biological hazards prostheses quality management system quantification of degradation route and duration sensitization single or multiple skin specific tests Subclause 7.2 technical committees teratogenicity test methods tests are described tests determine tests estimate tests evaluate tissue interaction Tissue/bone Tissue/bone/dentin vitro X X X