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ISO 10993-6:1994

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 10993-6:1994
Document Year: 1994
Pages: 11
Edition: 1
  • 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WITHDRAWN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 10993-6:1994
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