STN EN ISO 10993-4/Zmena A1
| Name: | STN EN ISO 10993-4/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 20 |
| Language: |
EN
|
| Paper: | 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 4: Výber skúšok na interakcie s krvou (ISO 10993-4: 2017/Amd 1: 2025, opravená verzia 2025-04) |
| English title | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| Release Date: | 01. 06. 2025 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6513 |
| Level of incorporation: | idt EN ISO 10993-4:2017/A1:2025, idt ISO 10993-4:2017/Amd 1 Corrected version:2025 |
| Official Journal | 05/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history |
| Preview: | Náhľad normy (PDF) |