IEC/NP TS 60601-4-1

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a level of autonomy

Scope

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.