Reference number
ISO 10993-1:2009
© ISO 2025
ISO 10993-1:2009
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Edition 4
2009-10
Withdrawn
Withdrawn (Edition 4, 2009)

Abstract

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     : Withdrawn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
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 4
    Number of pages
     : 21
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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