ISO 10993-6:1994
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Hardcopy , PDF
English, French
07-07-1994
02-11-2025
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).
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| AS ISO 10993.6-2002 | Identical |
| UNE-EN 30993-6:1995 | Identical |
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