Status
Gældende
Type
Standard
Varenummer
M324690
Lovgivning
Udgivelsesdato
2020-01-02
Komite
CENCLC/JTC 3
ISO/TC 210
International arbejdsgruppe WG
CENCLC/JTC 3
ISO/TC 210
Internationale relationer
ISO 14971:2019 IDT, EN ISO 14971:2019 IDT
Dansk udvalg
ICS grupper
Antal sider
52
Scope
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
– decisions on the use of a medical device in the context of any particular clinical procedure; or
– business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE – Guidance on the application of this document can be found in ISO/TR 24971[9].
Lovgivning
Harmoniseret underMedicinsk udstyr
Europa-Parlamentets og Rådets forordning (EU) 2017/745 af 5. april 2017 om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF (EØS-relevant tekst. )
Medicinsk udstyr til in vitro-diagnostik
Europa-Parlamentets og Rådets forordning (EU) 2017/746 af 5. april 2017 om medicinsk udstyr til in vitro-diagnostik og om ophævelse af direktiv 98/79/EF og Kommissionens afgørelse 2010/227/EU (EØS-relevant tekst. )