STN EN ISO 10993-1
| Name: | STN EN ISO 10993-1 |
| Validity: | Valid |
| Number of pages: | 64 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 1: Požiadavky a všeobecné princípy na hodnotenie biologickej bezpečnosti v rámci procesu manažérstva rizika (ISO 10993-1: 2025) |
| English title | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025) |
| Release Date: | 01. 04. 2026 |
| Date of withdrawal: | |
| ICS: | 11.100, 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-1:2025, idt ISO 10993-1:2025 |
| Official Journal | 03/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-1:2021-06 (85 6510) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either: — a patient's body during intended use or reasonably foreseeable misuse; or — the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks). Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: — constituents of a medical device; and — tissue-device interactions (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or ... |
| Preview: | Náhľad normy (PDF) |