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


Document Number: ISO 10993-1:2009
File Size: 672 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $126.00
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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 sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.

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