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ISO 10993 - Biological Evaluation of Medical Devices Package


Document Number: ISO 10993 - Biological Evaluation of Medical Devices Package
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $1,250.00
Product Details

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 10993-1:2009

ISO 10993-1/Cor1:2010

ISO 10993-2:2006

ISO 10993-3:2003

ISO 10993-4:2002

ISO 10993-4/Amd1:2006

ISO 10993-5:2009

ISO 10993-6:2007

ISO 10993-7:2008

ISO 10993-7/Cor1:2009

ISO 10993-9:2009

ISO 10993-10:2010

ISO 10993-10/Amd1:2006

ISO 10993-11:2006

ISO 10993-12:2007

ISO 10993-13:2010

ISO 10993-14:2001

ISO 10993-15:2000

ISO 10993-16:2010

ISO 10993-17:2002

ISO 10993-18:2005

ISO/TS 10993-19:2006

ISO/TS 10993-20:2006

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