IEC/AWI TS 80601-4-1

Projet

Un groupe de travail a préparé un projet.

Remplacera IEC/TR 60601-4-1:2017

Résumé

This document provides guidance for classifying LEVEL OF AUTONOMY (LOA) in MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEM or MEDICAL DEVICE SOFTWARE. Those types of MEDICAL DEVICE SOFTWARE that are not in scope of the IEC 60601 series of medical standards, can also make use of this document. This document also provides guidance on: – Methodologies to perform RISK MANAGEMENT PROCESS, USABILITY ENGINEERING and SOFTWARE LIFECYCLE PROCESSES for ME EQUIPMENT, ME SYSTEM, MEDICAL DEVICE SOFTWARE with an LOA; – Considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for ME EQUIPMENT, ME SYSTEM, MEDICAL DEVICE SOFTWARE with an LOA; Unless specified otherwise, this document considers ME EQUIPMENT and ME SYSTEM together. The MANUFACTURER of an ME EQUIPMENT or ME SYSTEM with an LOA is expected to design and manufacture an ME EQUIPMENT or ME SYSTEM that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE. This document provides guidance to help the medical MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2: 2020 for ME EQUIPMENT and ME SYSTEM with an LOA. The document is also intended as guidance for future standard writers. There are no prerequisites to this document.

Informations générales

État actuel
: Projet

Stade
: Nouveau projet enregistré au programme de travail du TC/SC [20.00]
Edition
: 1
Comité technique :
ISO/TC 299
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