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ISO 10993-1:2009

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

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 10993-1:2009
Document Year: 2009
Pages: 21
Edition: 4
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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WITHDRAWN
ISO 10993-1:2009
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