STN EN ISO 10993-15
| Name: | STN EN ISO 10993-15 |
| Validity: | Valid |
| Number of pages: | 32 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 15: Identifikácia a kvantifikácia degradačných produktov z kovov a zliatin (ISO 10993-15: 2019) |
| English title | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) |
| Release Date: | 01. 08. 2023 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-15:2023, idt ISO 10993-15:2019 |
| Official Journal | 07/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-15:2009-11 (85 6510) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use. This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. |
| Preview: | Náhľad normy (PDF) |