IS EN ISO 10993-1:2009 Biological evaluation of medical devices - Evaluation and testing within a risk management process (+AC:2010)
Publication Year
2009
Document Status
Withdrawn
Abstract
Specifies general principles that govern the biological evaluation of medical devices and the categorizing of devices based on the nature and duration of their contact with a body.
Document History
Corrigendum issued June 2010.
Publisher Information
National Standards Authority of Ireland
National Standards Authority of Ireland (NSAI) is Ireland’s official standards body. They operate under the National Standards Authority of Ireland Act (1996) and are accountable to the Minister of Enterprise, Trade, Employment and Innovation.
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