IEC/TR 60601-4-1:2017
(Main)Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
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.
Appareils électromédicaux — Partie 4-1: Titre manque
General Information
Buy Standard
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
IEC TR 60601-4-1:2017-05(en)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bi bliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
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
IEC TR 60601-4-1:2017 IEC 2017 – 3 –
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
...
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
IEC TR 60601-4-1:2017-05(en)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bi bliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
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
IEC TR 60601-4-1:2017 IEC 2017 – 3 –
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.