1、Medical electrical equipment Part 4-1: Guidance and interpretation Medical electrical equipment and medical electrical systems employing a degree of autonomy PD IEC/TR 60601-4-1:2017 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06IEC TR 60601-4-1 Edition 1.0 2017-0
2、5 TECHNICAL REPORT 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 Registered trademark of the International El
3、ectrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colour inside National foreword This 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/6
4、2/1, Common aspects of 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 appl
5、ication. The British Standards Institution 2017 Published by BSI Standards Limited 2017 ISBN 978 0 580 84736 3 ICS 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy
6、Committee on 30 June 2017. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 6060141:2017 IEC 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 ele
7、ctrical systems employing a degree 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. colour inside PD I
8、EC/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 b
9、etween 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 enginee
10、ring 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 PROGRA
11、MMABLE 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 ESSEN
12、TIAL 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 MONIT
13、OR 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 method
14、s for classifying DEGREE OF AUTONOMY 42 PD IEC/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 determin
15、e 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
16、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
17、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
18、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
19、 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 Table
20、s . 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 extrem
21、ity 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 classifica
22、tion 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 RIS
23、K MANAGEMENT PROCESS . 56 D.4.4 Summary and conclusions . 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 .
24、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 Automate
25、d 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 M
26、ANAGEMENT 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 PATIENTS sensory abilities
27、. 66 E.3.4 PATIENTS PHYSICAL ABILITIES 67 E.3.5 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
28、 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 “GEN
29、ERATE 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 Exa
30、mples 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 Ta
31、ble 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 Descr
32、iptive 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
33、 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 Examp
34、le 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 Ex
35、ample 6 Effect of DOA on the RISK MANAGEMENT PROCESS . 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
36、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
37、” 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
38、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 Lis
39、t 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 . 5
40、2 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
41、 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
42、 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 IEC TR 60601-4-1
43、: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 1) The International Electrotechnical Commission (IEC) is a worldwide or
44、ganization for standardization comprising all national 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 activitie
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