1、Medical electrical equipmentPart 4-1: Guidance and interpretation Medical electrical equipment and medical electrical systems employing a degree of autonomyPD IEC/TR 60601-4-1:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06IEC TR 60601-4-1Edition 1.0 2017-05TECH
2、NICAL REPORT Medical electrical equipment Part 4-1: Guidance and interpretation Medical electrical equipment and medical electrical systems employing a degree of autonomy INTERNATIONAL ELECTROTECHNICAL COMMISSIONICS 11.040.01 ISBN 978-2-8322-4329-9 Registered trademark of the International Electrote
3、chnical Commission Warning! Make sure that you obtained this publication from an authorized distributor.National forewordThis Published Document is the UK implementation of IEC/TR 60601-4-1:2017. The UK participation in its preparation was entrusted to Technical Committee CH/62/1, Common aspects of
4、Electrical Equipment used in Medical Practice.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Stan
5、dards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 84736 3ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2017.Am
6、endments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD IEC/TR 6060141:2017IEC TR 60601-4-1 Edition 1.0 2017-05 TECHNICAL REPORT Medical electrical equipment Part 4-1: Guidance and interpretation Medical electrical equipment and medical electrical systems employing a degre
7、e of autonomy INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01 ISBN 978-2-8322-4329-9 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. PD IEC/TR 6060141:2017 2 IEC TR 60601-4-1:2017 IEC
8、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 supp
9、orting 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 hig
10、her 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 so
11、ftware 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 (i
12、nformative) 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
13、 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 PD IEC/
14、TR 6060141:2017 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 betw
15、een 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 engineerin
16、g 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 PROGRAMMA
17、BLE 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 ESSENTIA
18、L 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
19、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 f
20、or 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 m
21、edical 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
22、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 con
23、clusions . 57 D.5 Example 4 Masterslave 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 equi
24、pment 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 Descrip
25、tion 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 T
26、ypes 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 PATIENTS sensory abilities . 66 E.3.4 PATIENTS PHYSICAL ABILITIES 67 E.3.5
27、 PATIENTS 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 PD IEC/TR 6060141:2017 4 IEC TR 60601-4-1:2017 IEC 2017 Figure 1 Basic mode
28、l 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 wei
29、ghted 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 TA
30、SK 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
31、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 Bin
32、ary 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 MANAGE
33、MENT 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
34、 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 PR
35、OCESS . 64 Table G.1 Examples of distributed ESSENTIAL PERFORMANCE (1 of 3) . 72 PD IEC/TR 6060141:2017 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
36、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 indicat
37、ing 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
38、 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 numb
39、er (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 ca
40、pability 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
41、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 .
42、 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 IEC TR 60601-4-1:2017 IEC 2017 5 INTERNATIONAL ELECTROTECHNICAL
43、 COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 4-1: Guidance and interpretation Medical electrical equipment and medical electrical systems employing a degree of autonomy FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all n
44、ational electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Techn
45、ical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work
46、. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2)
47、The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommenda
48、tions for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end
49、 user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly in
