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

ISO-10993-1 - 2ND EDITION - SUPERSEDED
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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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To find similar documents by classification:

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

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Document Number

ISO 10993-1:1997

Revision Level

2ND EDITION

Status

Superseded

Publication Date

Dec. 15, 1997

Committee Number

ISO/TC 194