Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - - User interface hazards (Fragment 3)
Abstract
The Scope clause is a mandatory element of the text. For rules on the drafting of the Scope, refer to the ISO/IEC Directives, Part 2:2018, Clause 14. This document applies to medical electrical equipment and medical electrical systems, hereafter referred to as MEE and MES. This document specifies the general requirements for the basic safety and essential performance of MEE and MES, intended for use by the specific users and in the specific environments of use as specified in the instructions for use (IFU). This document applies to software integrated into an MEE (SiMD). This document applies to software as a medical device (SaMD) in an MES when the SaMD contributes to basic safety or essential performance. This document can be applied to sub-assemblies of MEE or MES.
Begin
2025-01-09
Planned document number
DIN EN IEC 60601-1-103
Project number
02232841
Responsible national committee
DKE/UK 811.1 - Überarbeitung und Anpassung der allgemeinen Bestimmungen
