STN EN ISO 10993-17
| Name: | STN EN ISO 10993-17 |
| Validity: | Valid |
| Number of pages: | 80 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 17: Hodnotenie toxikologického rizika zložiek zdravotníckych pomôcok (ISO 10993-17: 2023) |
| English title | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
| Release Date: | 01. 03. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-17:2023, idt ISO 10993-17:2023 |
| Official Journal | 02/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-17:2009-08 (85 6510) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. |
| Preview: | Náhľad normy (PDF) |