SS ISO 10993-6:2017
Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
OVERVIEW
Specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
Applies to materials that are:
- solid and non-absorbable;
- non-solid, such as porous materials, liquids, gels, pastes and particulates; and
- degradable and/or absorbable, which may be solid or non-solid.
The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterise the history and evolution of the tissue response after implantation of a medical device / biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.
Does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2017 |
| No. of Pages | 40 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 10993-6 : 2016 IDT |