[PDF.16gi] ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

[PDF.oi14] ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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 | #11864682 in Books |  2009-10-13 |  2009-10-13 |  10.50 x.7 x8.20l, | File type: PDF | 30 pages

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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 set...
  
  You can specify the type of files you want, for your device.ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process   |  ISO/TC 194. A good, fresh read, highly recommended.
  
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