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›ComplianceOnline Standards
›ISO ICS 11 HEALTH CARE TECHNOLOGY
› ISO 10993 - Biological Evaluation of Medical Devices Package
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
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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