ISO 10993-11:2006 

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

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General information

Number of Pages: 26


Edition: 2 (Monolingual) ICS: 11.100.20
Status: Published Stage: 90.20 (2009-07-15)
TC/SC: TC 194  

Abstract

ISO 10993-11:2006 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Revision information

Revises: ISO 10993-11:1993

These standards could also interest you

  • ISO 10993-1:2009
    Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
  • ISO 10993-5:2009
    Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-7:2008
    Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
 
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