CEN/TC 206
| Project No. | prEN ISO 10993-16 |
|---|---|
| Title | This document describes the considerations to include the toxicokinetic evaluation of single chemical which can include its degradant or metabolite known to be released from a medical device. This document provides the principles for designing and performing a toxicokinetic evaluation for medical devices. |
| Registration number (WIID) | 78991 |
| Scope | This document describes the considerations to include the toxicokinetic evaluation of single chemical which can include its degradant or metabolite known to be released from a medical device. This document provides the principles for designing and performing a toxicokinetic evaluation for medical devices. |
| Status | Aptauja slēgta |
| ICS group | 11.100.20 |