IEC TR 60601-4-1:2017

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(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.

General Information

• Status: Published
• Publication Date: 21-May-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 9 - TC 62/SC 62A/JWG 9
• Current Stage: PPUB - Publication issued
• Start Date: 23-May-2017
• Completion Date: 22-May-2017

Standards Content (Sample)

IEC TR 60601-4-1
Edition 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
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IEC TR 60601-4-1
Edition 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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-4329-9

– 2 – IEC TR 60601-4-1:2017  IEC 2017
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 DEGREE OF AUTONOMY (DOA) . 17
4.1 Introduction to DEGREE OF AUTONOMY . 17
4.2 Methodology to determine DEGREE OF AUTONOMY . 17
4.3 Relationship between DOA and RISK . 18
5 PROCESS STANDARDS supporting DOA . 18
5.1 General . 18
5.2 RISK MANAGEMENT PROCESS . 19
5.2.1 Defining INTENDED USE . 19
5.2.2 INTENDED USE and characteristics related to SAFETY . 19
5.3 RISK CONTROL . 20
5.3.1 General . 20
5.3.2 RISK CONTROL hierarchy . 21
5.4 USABILITY engineering considerations for MEE or MES having a higher DOA . 22
5.4.1 General . 22
5.4.2 OPERATOR situation awareness . 22
5.4.3 OPERATOR reaction time . 23
5.4.4 OPERATOR sensory input and response . 23
5.4.5 Detectability by OPERATOR of malfunction or errors of MEE or MES with a
higher DOA . 23
5.5 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) and software
development LIFE CYCLE (IEC 62304) . 23
5.6 Application of RISK MANAGEMENT for IT-networks incorporating medical
devices . 24
6 BASIC SAFETY and ESSENTIAL PERFORMANCE related to DOA . 25
6.1 GENERAL . 25
6.2 BASIC SAFETY related to DOA . 25
6.3 ESSENTIAL PERFORMANCE related to DOA . 26
Annex A (informative) Rationale for defining the AUTOMATIC, AUTONOMY and DOA
framework and the distinction between a MEDICAL ROBOT and other MEE or MES . 28
A.1 General . 28
A.2 Existing definitions and limitations . 28
A.3 New approaches . 29
A.4 Definition of MONITOR – GENERATE – SELECT – EXECUTE . 30
A.5 Approaches to define ROBOT and MEDICAL ROBOT . 31
A.6 Conclusions . 31
Annex B (informative) DOA and relevant terms used in MEE standards. 32
B.1 General . 32
B.2 Procedure . 32
B.3 Results . 32
B.3.1 Summary . 32
B.3.2 Tables . 33
Annex C (informative) Exemplar methods for classifying DEGREE OF AUTONOMY . 42

C.1 Descriptive method . 42
C.2 Binary method . 43
C.3 Weighted method . 44
Annex D (informative) Examples of introducing DOA to MEE/MES . 50
D.1 General . 50
D.2 Example 1 – Lower extremity exoskeleton . 50
D.2.1 Description of the medical procedures . 50
D.2.2 DOA classification method . 50
D.2.3 Effect of DOA on the RISK MANAGEMENT PROCESS . 52
D.3 Example 2 – Orthopaedic MEE/MES/MEDICAL ROBOT for reshaping bone . 54
D.3.1 Description of the medical procedures . 54
D.3.2 DOA classification method . 54
D.3.3 Effect of DOA on the RISK MANAGEMENT PROCESS . 55
D.3.4 Summary and conclusions . 55
D.4 Example 3 – Instrument exchange on robotically-assisted surgical equipment . 55
D.4.1 Description of the medical procedures . 55
D.4.2 DOA classification method . 56
D.4.3 Effect of DOA on the RISK MANAGEMENT PROCESS . 56
D.4.4 Summary and conclusions . 57
D.5 Example 4 – Master–slave robotically-assisted surgical equipment . 57
D.5.1 Description of the medical procedures . 57
D.5.2 DOA classification method . 58
D.5.3 Effect of DOA on RISK MANAGEMENT PROCESS . 58
D.5.4 Summary and conclusions . 58
D.6 Example 5 – Image-guided radiotherapy equipment . 58
D.6.1 Description of the medical procedures . 58
D.6.2 DOA classification method . 59
D.6.3 RISK ANALYSIS for each level of DOA . 61
D.6.4 Effect of DOA on the RISK MANAGEMENT PROCESS . 61
D.6.5 Summary and conclusions . 61
D.7 Example 6 – Automated external defibrillator (AED) . 62
D.7.1 Description of the medical procedures . 62
D.7.2 DOA classification method . 63
D.7.3 Effect of DOA on the RISK MANAGEMENT PROCESS . 64
D.7.4 Summary and conclusions . 64
Annex E (informative) PATIENT SAFETY characteristics to be taken into account during
RISK MANAGEMENT for MEE or MES employing DOA . 65
E.1 Types of PATIENTS . 65
E.2 Additional attention for child (PATIENT) SAFETY . 65
E.3 PATIENT abilities and variability of physiological signals . 66
E.3.1 ISO/IEC Guide 71 . 66
E.3.2 Changing need and abilities of PATIENTS . 66
E.3.3 PATIENT’S sensory abilities . 66
E.3.4 PATIENT’S PHYSICAL ABILITIES . 67
E.3.5 PATIENT’S COGNITIVE ABILITIES . 67
E.3.6 PATIENT ALLERGIES . 67
ANNEX F (informative) PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM AND DOA . 69
Annex G (informative) Examples of distributed ESSENTIAL PERFORMANCE . 72
Bibliography . 75

– 4 – IEC TR 60601-4-1:2017  IEC 2017

Figure 1 – Basic model of interoperability of MEE in an MES (Order of execution: 1 to 3) . 25
Figure A.1 – ALFUS approach applied to MEE or MES applications . 30
Figure C.1 – Application of weighted method to the “MONITOR” T
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