Draft
International Standard
ISO/DIS 10993-11
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Reference number
ISO/DIS 10993-11
Edition 4
© ISO 2025
Draft International Standard
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-11:2017

Abstract

ISO 10993-11:2017 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.

General information

  • Status
     : Under development
    Stage
    : DIS registered [40.00]
  • Edition
     : 4
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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