Studies are designed according to international guidelines, especially ISO 10993.
We study any particular type of protocol you may require : number of models, time of application, observation frequency…
Assessment of Medical Devices
Experimental Testing
| Guideline | Study |
| ISO 10993-6 |
Test for local effects after implantation |
|
ISO 10993-11 |
Test for systemic effects after implantation |
| ISO 10993-10 |
Intradermal irritation |
| ISO 10993-10 |
Dermal irritation |
| ISO 10993-10 |
Dermal irritation after 5 repeated applications |
| ISO 10993-10 |
Ocular Irritation |
| ISO 10993-10 |
Sensitization - Magnusson & Kligman test (polar extract - non polar extract) |
| ISO 10993-10 |
Sensitization - LLNA test |
| ISO 10993-10 |
Vaginal irritation (acute or repeated tolerance) |
| ISO 10993-10 |
Anal irritation (acute or repeated tolerance) |
|
ISO 10993-10 JORF 17/06/92 |
Local tolerance by repeated application on cheek pouch |
| ISO 10993-11 |
Acute intravenous toxicity (polar extract) |
| ISO 10993-11 |
Acute intrapéritoneal toxicity (non polar extract) |
| ISO 10993-11 |
Acute toxicity in Mouse (polar extract - non polar extract) |
|
ISO 10993-11 Eur. Pharm. Edit. 7 |
Pyrogene |
| USP 32 |
Acute systemic toxicity (4 extracts : 2 iv - 2 ip) |
| USP 32 |
Acute intradermal toxicity (4 extracts : 2 iv - 2 ip) |
In vitro testing
| Guideline | Study |
| ISO 10993-5* |
Cytotoxicity (L929 cells) |
* With G.L.P. partner in Europe
