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

Status
Published
Publication Date
03-Jul-2017
Technical Committee
Drafting Committee
Current Stage
6060 - International Standard published
Completion Date
04-Jul-2017
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IEC TR 60601-4-1
Edition 1.0 2017-05
TECHNICAL
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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)

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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



  Warning! Make sure that you obtained this publication from an authorized distributor.

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– 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

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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

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– 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” TASK . 45
Figure C.2 – Application of weighted method to “GENERATE OPTIONS” . 46
Figure C.3 – Application of weighted method to “SELECT OPTION” TASK . 47
Figure C.4 – Application of weighted method to the “EXECUTE” TASK . 48
Figure F.1 – Functional diagram indicating typical components of a PHYSIOLOGIC
CLOSED-LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC . 69
Figure F.2 – Examples of introducing DOA into the MONITORING TASK via PCLCS . 70
Figure F.3 – Examples of introducing DOA into the GENERATING TASK via PCLCS . 70
Figure F.4 – Examples of introducing DOA into the SELECTION TASK via PCLCS . 70
Figure F.5 – Examples of introducing DOA into the EXECUTION TASK via PCLCS . 71

Table 1 – Examples of ESSENTIAL PERFORMANCE of MEE or MES with a DOA . 27
Table B.1 – List of terms that indicate the use of AUTONOMY . 33
Table B.2 – List of reviewed standards – sorted by standard number (1 of 4) . 34
Table B.3 – List of identified inconsistencies in reviewed standards (1 of 2) . 40
Table C.1 – Descriptive classification of DOA . 43
Table C.2 – Binary classification of DOA . 44
Table D.1 – Example 1 – Effect of DOA on the RISK MANAGEMENT PROCESS . 52
Table D.2 – Example 1 – Physical and cognitive capability of individual and CLINICAL
FUNCTION needed . 52
Table D.3 – Example 1 – Sub-function TASK example . 53
Table D.4 – Example 2 – Effect of DOA on the RISK MANAGEMENT PROCESS . 55
Table D.5 – Example 3 – Comparison of instrument exchange design implementations . 57
Table D.6 – Example 3 – Effect of DOA on the RISK MANAGEMENT PROCESS . 57
Table D.7 – Example 4 – Effect of DOA on the RISK MANAGEMENT PROCESS . 58
Table D.8 – Example 5 – Descriptive classification of DOA for IGRT MEE . 60
Table D.9 – Example 5 – Binary classification of DOA for IGRT MEE . 60
Table D.10 – Example 5 – Effect of DOA on the RISK MANAGEMENT PROCESS . 62
Table D.11 – Example 6 – Descriptive method classification of DOA in external
defibrillators . 63
Table D.12 – Example 6 – Effect of DOA on the RISK MANAGEMENT PROCESS . 64
Table G.1 – Examples of distributed ESSENTIAL PERFORMANCE (1 of 3) . 72

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IEC TR 60601-4-1:2017 © IEC 2017 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 60601-4-1, which is a technical report, has been prepared by a Joint Working Group of
IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of
IEC technical committee 62: Electrical equipment in medical practice, and ISO technical
committee 299: Robotics.
It is published as a double logo standard.

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– 6 – IEC TR 60601-4-1:2017 © IEC 2017
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/1099/DTR 62A/1129A/RVDTR

Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this technical report, the following print types are used:
– recommendations and definitions: roman type.
– test instructions: italic type.
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THIS TECHNICAL REPORT OR AS NOTED: SMALL CAPITALS.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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IEC TR 60601-4-1:2017  IEC 2017 – 7 –
INTRODUCTION
This Technical Report is the result of work that began in ISO/TC 184/SC 2/WG 7 in October
2006 on personal care ROBOTS, to address an emerging type of ROBOT that was used outside
of an industrial environment. That group was working on a new standard, ISO 13482, which
was published as an International Standard (IS) in 2014. While initially focused on non-
medical applications, WG 7 recognized that work was likely to be needed on medical devices
utilizing robotic technology. In September 2009, ISO/TC 184/SC 2 established a WG 7, Study
Group (SG) on Medical care robots, comprised of experts from Canada, France, Germany,
Japan, Korea, Romania, Switzerland, UK and USA.

1
The work of ISO/TC 184/SC 2/WG 7 SG cumulated in a proposal to form a Joint Working
Group with IEC/SC 62A to develop general requirements and guidance related to the SAFETY
of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS that utilize robotic
technology. The work would include medical applications (including aids for the disabled)
covering invasive and non-invasive procedures such as surgery, rehabilitation therapy,
imaging and other ROBOTS for medical diagnosis and treatment. The proposal was approved,
resulting in the formation of Joint Working Group (JWG) 9 (Medical electrical equipment and
systems using robotic technology) and the first meeting was held in Los Angeles in June
2011.
JWG 9 examined the definition of a ROBOT from ISO 8373:2012 (which was later modified to a
“programmed actuated mechanism with a DEGREE OF AUTONOMY (DOA), moving within its
environment, to perform intended TASKS”) and AUTONOMY (the “ability to perform intended
TASKS based on current state and sensing, without human intervention”). It was recognized by
JWG 9 that these definitions could need further refinement to establish the appropriate
boundaries for future standardisation work. AUTONOMY and DEGREE OF AUTONOMY (DOA) were
felt to be key ingredients in distinguishing a “MEDICAL ROBOT” from other types of MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMs.
However, JWG 9 came to realize that there are currently standardized MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS that exhibit a DOA. Therefore, DOA by itself is not
a unique characteristic of a MEDICAL ROBOT. This can be stated more clearly as follows:
– not all MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS that exhibit a DOA
are MEDICAL ROBOTS; but
– all MEDICAL ROBOTS exhibit a DOA.
Hence a MEDICAL ROBOT can be a MEDICAL ELECTRICAL EQUIPMENT or part of a MEDICAL
ELECTRICAL SYSTEM, but not all MEDICAL ELECTRICAL EQUIPMENT are MEDICAL ROBOTS.
NOTE The majority of existing MEDICAL ELECTRICAL EQUIPMENT are not considered as MEDICAL ROBOTs.
The MANUFACTURER states clearly the type of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEM through the INTENDED USE of their product. For this INTENDED USE, a
definition of MEDICAL ROBOT would be helpful to have a common understanding if this MEDICAL
ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM can be tagged as a MEDICAL ROBOT
MEDICAL ROBOT system. The definition of MEDICAL ROBOT is therefore helpful to
equipment or
distinguish if the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM is a MEDICAL
ROBOT and the INTENDED USE as indicated by the MANUFACTURER. This distinction is clarified in
Annex A.
DOA is normally considered for adoption into MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS for the following reasons:
– DOA could give benefits to CLINICAL FUNCTION outcomes;
___________
1)
ISO TC 184/SC 2 was reformed to ISO TC 299 in January 2016.

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– 8 – IEC TR 60601-4-1:2017  IEC 2017
– DOA could give economic value to MEDICAL ELECTRICAL EQUIPMENT;
– DOA could improve the consistency of medical procedures;
– DOA could handle more complex data;
– DOA could lead to faster reaction times;
– DOA could optimise medical procedure times or duration;
– DOA could make it easier to integrate MEDICAL ELECTRICAL SYSTEMS;
– DOA could decrease the overall level of RISK; and
– DOA could change the role of an OPERATOR to a more supervisory than active (hands on)
function.
In order to progress the work of JWG 9, it was agreed to focus on the IEC 60601-1 standard
family and see how specific clauses could be extended to cover the additional DOA issues in a
possible new Technical Report once fully developed. JWG 9 looked at existing MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS that had characteristics of a ROBOT
based on the definition, and investigated the suitability of the existing standards to address
the HAZARDS associated with their use. As a result of this investigation, it was acknowledged
that IEC 60601 (all parts), ISO 14971, IEC 62366-1 and IEC 62304 provide appropriate
general requirements and guidance on how to address the HAZARDS; however, emerging
functionality associated with increased DOA on MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, whether a ROBOT or not, could result in situations where BASIC SAFETY
and ESSENTIAL PERFORMANCE are considered again by the MANUFACTURER.
Current MEDICAL ELECTRICAL EQUIPMENT standards do not fully address higher DOA modes of
operation, and this document is intended to provide guidance for MANUFACTURERS and others
in this field on how DOA could be introduced into MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS. Incorporation of higher levels of AUTONOMY in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS is still new and rapidly evolving, and at the time
of writing this document does not lend itself to general standardization.
The importance of understa
...

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