Tagasi

CEN ISO/TR 24971:2020

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

Üldinfo
Kehtiv alates 03.08.2020
Alusdokumendid
ISO/TR 24971:2020; CEN ISO/TR 24971:2020
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
03.08.2020
Põhitekst
ISO/TR 24971 provides guidance to assist in the development, implementation and maintenance of a risk management process for medical devices. It provides guidance on the application of ISO 14971 for a wide variety of medical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices, software as medical devices and in vitro diagnostic medical devices. CEN ISO/TR 24971 describes approaches that manufacturers can use for a risk management process conforming to ISO 14971.

When judging the applicability of the guidance, you should consider the nature of the medical devices to which it will apply. Consider how and by whom these medical devices are used, and the applicable regulatory requirements. The same structure and numbering of clauses and subclauses as in ISO 14971 is employed to facilitate the use of ISO/TR 24971. The text of ISO/TR 24971:2020 has been approved in Europe as CEN ISO/TR 24971:2020 without any changes.
*
*
*
PDF
39,04 € koos KM-ga
Paber
39,04 € koos KM-ga
Sirvi standardit alates 2,44 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst + muudatus

EVS-EN 62366-1:2015+A1:2020

Meditsiiniseadmed. Osa 1: Kasutatavusprojekteerimise rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 17.08.2020
Põhitekst

EVS-EN ISO 14971:2019

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Kehtiv alates 02.01.2020
Põhitekst + muudatus

EVS-EN ISO 14971:2019+A11:2021

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 15.12.2021
Põhitekst + muudatus

EVS-EN 62304:2006+A1:2015

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Uusim versioon Kehtiv alates 15.11.2019