STN EN ISO 10993-9
| Name: | STN EN ISO 10993-9 |
| Validity: | Valid |
| Number of pages: | 24 |
| Language: |
EN
|
| Hard copy: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 9: Osnova na identifikáciu a kvantifikáciu potenciálnych degradačných výrobkov (ISO 10993-9: 2019) |
| English title | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
| Release Date: | 01. 01. 2022 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-9:2021, idt ISO 10993-9:2019 |
| Official Journal | 12/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-9:2010-05 (85 6510) |
| Note in Official Journal: | |
| Subject of the standard: | This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. |
| Preview: | Náhľad normy (PDF) |