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
Read sample
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-11:2017

ISO/DIS 10993-11

Language
Format
CHF 65
Convert Swiss francs (CHF) to your currency

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

    You can help develop this draft international standard by contacting your national member

    Stage
    : DIS ballot initiated: 12 weeks [40.20]
  • Edition
     : 4
    Number of pages
     : 36
  • 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

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. ICS
  5. 11
  6. 11.100
  7. 11.100.20
  8. ISO/DIS 10993-11