Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.459
/ Documenti scaricati: 32.294.219
/ Documenti scaricati: 32.294.219
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
ID 22515 | 06.09.2024 / Preview in allegato
UNI 11018-2:2024 Facciate ventilate - Parte 2: Istruzioni per la progettazione, l'esecuzione e la manutenzion...
ID 17885 | 19.10.2022 / Preview in allegato - Pubblicazione UNI 13 Ottobre 2022
Protezioni antiurto in ambito ind...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024