ISO 10993-1:2009

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

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.


General information

  • Status :  Withdrawn
    Publication date : 2009-10
  • Edition : 4
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

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