Standard Tekniska rapporter · SIS-CEN ISO/TR 24971:2020

Medicintekniska produkter - Vägledning vid tillämpningen av ISO 14971 (ISO/TR 24971:2020)

Status: Gällande

Omfattning
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[24], 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[25].

Ämnesområden

Speciell utrustning (01.080.20) Medicinsk utrustning allmänt (11.040.01) Farmakopéprodukter allmänt (11.120.01)


Produktinformation

Språk: Engelska

Framtagen av: Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik, SIS/TK 355

Internationell titel: Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

Artikelnummer: STD-80023881

Utgåva: 1

Fastställd: 2020-09-02

Antal sidor: 100

Ersätter: SIS-ISO/TR 24971:2020