This Part of IEC 60601 is intended to help a MANUFACTURER through the key decisions and steps to be taken to perform a detailed RISK MANAGEMENT and USABILITY ENGINEERING PROCESSES for MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM, hereafter referred to as MEE or MES, employing a DEGREE OF AUTONOMY (DOA). This document provides a definition of DOA of MEE or MES and a MEDICAL ROBOT, and also provides guidance on:
– methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for an MEE or MES with a DOA;
– considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with a DOA; and
– identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
– distinguishing between MEDICAL ROBOTS, and other MEE and MES.
Unless specified otherwise, this document considers MEE and MES together.
The MANUFACTURER of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE.
This document provides guidance to help the MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
There are no prerequisites to this document.dition 1.0 2017-05 TECHNICAL REPORT colour inside Medical electrical equipment – Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy IEC TR 60601-4-1:2017-05(en) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright ？ 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be rep