Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Preview in attachment
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices - A practical guide.
Collegati
| Descrizione | Lingua | Dimensioni | Downloads | |
|---|---|---|---|---|
 |
Abbonati Normazione
|
IT | 3155 kB | 21 |
Measurement of radioactivity in the environment - Soil - Part 1: General guidelines and definitions
ISO Publication date: 2019-11
...
In allegato Preview ISO 1859-1:2019 riservata Abbonat...
ID 16763 | 02.06.2022 / In allegato Preview
La norma specifica i requisiti di sicurezza relativi alla progettazione e alla costruzione di calandre destinate a calandratu...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024