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

ISO-10993-1 - 4TH EDITION - CURRENT
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Included in this current edition are the following subparts:

 4TH EDITION - Oct. 15, 2009
 4TH EDITION CORRIGENDUM 1 - June 15, 2010

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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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-1:2009

Revision Level

4TH EDITION

Status

Current

Publication Date

Oct. 15, 2009

Committee Number

ISO/TC 194