STN P CEN ISO/TS 24971-2
| Name: | STN P CEN ISO/TS 24971-2 |
| Validity: | Valid |
| Number of pages: | 44 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícke pomôcky. Usmernenie k používaniu ISO 14971. Časť 2: Strojové čítanie prostredníctvom umelej inteligencie (ISO/TS 24971-2: 2026) |
| English title | Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026) |
| Release Date: | 01. 10. 2026 |
| Date of withdrawal: | |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5003 |
| Level of incorporation: | idt CEN ISO/TS 24971-2:2026, idt ISO/TS 24971-2:2026 |
| Official Journal | 09/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do júna 2028 Úradu pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky. |
| Subject of the standard: | This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI. |
| Preview: | Náhľad normy (PDF) |