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ISO 10993 - Biological Evaluation of Medical Devices Package

ISO 10993 - Medical Devices Complete Set, Parts 1 thru 20

The ISO 10993 - Biological Evaluation of Medical Devices Package has an array of standards on testing, the identification / quantification of degradation products and other general biological evaluation of medical devices. The general biological evaluation of medical devices standards in this package include basic evaluation and testing, sterilization residuals, limits for leachable substances, and the preparation of samples / reference materials for testing. The referenced products are for the identification / quantification of degradation products are metals / alloys, ceramics and polymeric devices. These particular standards are supported by a toxicokinetic study design standard and framework standard for potential degradation products. The medical devices tests in this package are for system toxicity, hypersensitivity, local effects after implantation, genotoxicity, carcinogenicity, reproductive toxicity and interactions with blood. This package is 45% off the individual list price and includes the following standards:

ISO 10993-1:2018

ISO 10993-2:2006

ISO 10993-3:2014

ISO 10993-4:2017

ISO 10993-5:2009

ISO 10993-6:2016

ISO 10993-7:2008

ISO 10993-7/Cor1:2009

ISO 10993-9:2009

ISO 10993-10:2010

ISO 10993-11:2017

ISO 10993-12:2012

ISO 10993-13:2010

ISO 10993-14:2001

ISO 10993-15:2000

ISO 10993-16:2017

ISO 10993-17:2002

ISO 10993-18:2005

ISO/TS 10993-19:2006

ISO/TS 10993-20:2006

ISO 10993 - Biological Evaluation of Medical Devices Package includes:

Content Provider
International Organization for Standardization [ISO]


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