Kvalitetsledningssystem inom hälso och sjukvård

Kommittébeteckning: SIS/TK 355 (Medicintekniska kvalitetssystem)
Källa: CEN
Svarsdatum: den 2 okt 2018
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This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) 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 stages of the life-cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as for example those related to biocompatibility, data and systems security, electricity, moving parts, radiation, usability, and other risks.

This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure. This document does also not apply to business risk management.

This document does not specify acceptable risk levels, but requires manufacturers to establish objective criteria for risk acceptability.

This document does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

NOTE Guidance on the application of this document can be found in ISO/TR 24971 [9].