ISO 10993-6:1994

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

Publication date:   Jul 7, 1994

95.99 Withdrawal of Standard   Apr 4, 2007

General information

95.99 Withdrawal of Standard   Apr 4, 2007

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

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).

Life cycle

NOW

WITHDRAWN
ISO 10993-6:1994
95.99 Withdrawal of Standard
Apr 4, 2007

REVISED BY

WITHDRAWN
ISO 10993-6:2007