[PDF.35fk]  ISO 10993-1:2009, Biological evaluation of medical devices - Part 1:..* ISO/TC 194

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ISO 10993-1:2009 describes:

• the general principles governing the biological evaluation of medical devices within a risk management process;
• the general categorization of devices based on the nature and duration of their contact with the body;
• the evaluation of existing relevant data from all sources;
• the identification of gaps in the available data set on the basis of a risk analysis;
• the identification of additional data se...
  
  [PDF.we53]  ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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