Reference number
ISO 10993-6:1994
© ISO 2024
ISO 10993-6:1994
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Edition 1
1994-07
Withdrawn
Withdrawn (Edition 1, 1994)

Abstract

Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

General information

  • Status
     : Withdrawn
    Publication date
     : 1994-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 11
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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