STN EN ISO 10993-1
| Name: | STN EN ISO 10993-1 |
| Validity: | Valid |
| Number of pages: | 52 |
| Language: |
EN
|
| Hard copy: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 1: Hodnotenie a skúšanie v systéme manažérstva rizika (ISO 10993-1: 2018, vrátane opravenej verzie 2018-10) |
| English title | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10) |
| Release Date: | 01. 06. 2021 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-1:2020, idt ISO 10993-1 Corrected version 2018-10:2018 |
| Official Journal | 05/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-1:2010-05 (85 6510) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). |
| Preview: | Náhľad normy (PDF) |