IEC TR 60601-4-1:2017

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 DEGREE OF AUTONOMY (DOA)
5 PROCESS STANDARDS supporting DOA
6 BASIC SAFETY and ESSENTIAL PERFORMANCE
  related to DOA
Annex A (informative) - Rationale for defining
        the AUTOMATIC, AUTONOMY and DOA framework
        and the distinction between a MEDICAL
        ROBOT and other MEE or MES
Annex B (informative) - DOA and relevant terms
        used in MEE standards
Annex C (informative) - Exemplar methods for
        classifying DEGREE OF AUTONOMY
Annex D (informative) - Examples of introducing
        DOA to MEE/MES
Annex E (informative) - PATIENT SAFETY
        characteristics to be taken into account
        during RISK MANAGEMENT for MEE or MES
        employing DOA
ANNEX F (informative) - PHYSIOLOGIC CLOSED-LOOP
        CONTROL SYSTEM AND DOA
Annex G (informative) - Examples of distributed
        ESSENTIAL PERFORMANCE
Bibliography

IEC TR 60601-4-1:2017(E) 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.