SR EN 30993-6:1998

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

This part of ISO 10993 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 test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. 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Status : Withdrawn
Approval date : 8/15/1997
Publish date : 8/16/1997
Withdrawal date : 9/28/2007
Number of pages : 24
ICS : 11.020 Medical sciences and health care facilities in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR ISO 5832-2:1996
Normative reference SR EN 30993-1:1996
Normative reference SR ISO 5832-3:1996
Normative reference SR ISO 5832-7:1996
Normative reference SR ISO 5832-5:1996
Normative reference SR ISO 10993-2:1996
Replaced by SR EN ISO 10993-6:2007