BS PD IEC TR 62366-2-2016 Medical devices Guidance on the application of usability engineering to medical devices《医疗器械 医疗器械可用性工程应用指南》.pdf

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1、Medical devices Part 2: Guidance on the application of usability engineering to medical devices PD IEC/TR 62366-2:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of IEC/TR 62366-2:2016. Together

2、 with BS EN 62366-1:2015, it supersedes BS EN 62366:2008+A1:2015 which will be withdrawn on 31 March 2018. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment use

3、d in Medical Practice. A list of organizations represented on this subcommittee 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 Standards Institution 2

4、016. Published by BSI Standards Limited 2016 ISBN 978 0 580 85673 0 ICS 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2016. Amendments/corr

5、igenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 62366-2:2016IEC TR 62366-2 Edition 1.0 2016-04 TECHNICAL REPORT Medical devices Part 2: Guidance on the application of usability engineering to medical devices INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01 ISBN

6、 978-2-8322-3346-7 Warning! Make sure that you obtained this publication from an authorized distributor. colour inside 2 IEC TR 62366-2:2016 IEC 2016 CONTENTS FOREWORD . 6 INTRODUCTION . 8 1 Scope and purpose 9 1.1 Scope . 9 1.2 Purpose 9 2 Normative references. 10 3 Terms and definitions 11 4 Mappi

7、ng between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2 . 14 5 Background and justification of the USABILITY ENGINEERING program 14 5.1 How SAFETY relates to USABILITY 14 5.2 Reasons to invest in USABILITY ENGINEERING . 15 6 How to implement a USABILITY ENGINEERING program . 16

8、 6.1 Effective USABILITY ENGINEERING programs . 16 6.2 Effective USABILITY ENGINEERING projects and plans 16 6.3 Apply an appropriate level of USABILITY ENGINEERING expertise . 17 6.4 Ensure the necessary resources are available and well timed 18 6.5 RISK MANAGEMENT as it relates to USABILITY ENGINE

9、ERING 18 6.5.1 RISK ANALYSIS . 18 6.5.2 RISK CONTROL . 19 6.5.3 Information for SAFETY 20 6.5.4 Overall evaluation of RESIDUAL RISK 22 6.6 USABILITY ENGINEERING FILE 22 6.7 Tailoring the USABILITY ENGINEERING effort 23 7 Overview of the USABILITY ENGINEERING PROCESS . 24 8 Prepare the USE SPECIFICAT

10、ION . 27 8.1 Initiate USE SPECIFICATION 27 8.2 Analyse the intended USERS, anticipated USER TASKS and intended USE ENVIRONMENTS . 28 8.2.1 Intended USERS 28 8.2.2 Anticipated USER TASKS 30 8.2.3 Intended USE ENVIRONMENT . 30 8.3 Finalize the USE SPECIFICATION . 30 8.4 Recommended methods for develop

11、ing the USE SPECIFICATION . 31 8.4.1 General . 31 8.4.2 Contextual inquiry and observation . 31 8.4.3 Interview and survey techniques . 31 8.4.4 Expert reviews . 32 8.4.5 Advisory panel reviews . 32 8.4.6 USABILITY TESTS . 32 9 Identify USER INTERFACE characteristics related to SAFETY and potential

12、USE ERRORS 32 9.1 General . 32 9.2 TASK ANALYSIS . 33 9.3 FUNCTION ANALYSIS 33 9.4 Identify and analyse known problems 35 PD IEC/TR 62366-2:2016IEC TR 62366-2:2016 IEC 2016 3 10 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 35 11 Identify and describe HAZARD-RELATED USE SCENARIOS

13、. 36 11.1 Define USE SCENARIOS 36 11.2 USE SCENARIOS as they relate to RISK MANAGEMENT . 36 11.3 Identify HAZARD-RELATED USE SCENARIOS . 37 11.4 Methods to define and analyse HAZARD-RELATED USE SCENARIOS . 37 12 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 38 12.1 General . 38

14、12.2 Selection of the HAZARD-RELATED USE SCENARIOS based on SEVERITY . 39 12.3 Selection of HAZARD-RELATED USE SCENARIOS based on other circumstances . 39 13 Establish USER INTERFACE SPECIFICATION . 40 13.1 Development of the USER INTERFACE SPECIFICATION . 40 13.2 ACCOMPANYING DOCUMENTATION and trai

15、ning 40 14 Establish USER INTERFACE EVALUATION plan . 41 14.1 Specify how the USER INTERFACE design will be explored and evaluated 41 14.2 FORMATIVE EVALUATION planning . 42 14.3 SUMMATIVE EVALUATION planning 42 14.4 USABILITY TEST planning . 43 14.5 Example USABILITY TEST protocol and report . 43 1

16、5 Design and implement the USER INTERFACE and training 44 15.1 General . 44 15.2 Develop conceptual model(s). 46 15.3 Design software USER INTERFACES (if applicable) 47 15.3.1 General . 47 15.3.2 Review USER INTERFACE REQUIREMENTS and constraints . 47 15.3.3 Develop software USER INTERFACE structure

17、(s) 47 15.3.4 Design wireframes . 48 15.3.5 Design screen templates 48 15.4 Design hardware USER INTERFACES (if applicable) . 48 15.4.1 General . 48 15.4.2 Review USER INTERFACE REQUIREMENTS and constraints . 49 15.4.3 Develop concept sketches 49 15.5 Design materials necessary for training and trai

18、ning 49 15.5.1 General . 49 15.5.2 Training materials 49 15.5.3 Training . 51 15.6 Develop detailed designs . 52 15.7 Verify the design of the USER INTERFACE . 52 16 Perform FORMATIVE EVALUATIONS 52 16.1 Conduct multiple FORMATIVE EVALUATIONS . 52 16.2 Recommended methods for FORMATIVE EVALUATION 53

19、 16.2.1 General . 53 16.2.2 Conduct heuristic analysis 54 16.2.3 Conduct cognitive walkthrough . 54 16.2.4 Conduct USABILITY TESTS 54 16.3 Analysis of FORMATIVE EVALUATION results 55 17 Perform SUMMATIVE EVALUATION 55 17.1 General . 55 PD IEC/TR 62366-2:2016 4 IEC TR 62366-2:2016 IEC 2016 17.2 Condu

20、ct a SUMMATIVE EVALUATION 56 17.3 Data collection 57 17.3.1 General . 57 17.3.2 Observational data . 57 17.3.3 Subjective data 58 17.4 Data analysis 59 18 Document the USABILITY ENGINEERING project 61 19 POST-PRODUCTION review and analysis . 61 Annex A (informative) Recommended reading list . 64 Ann

21、ex B (informative) External resources to identify known problems . 66 B.1 General . 66 B.2 Austria 66 B.3 Germany . 66 B.4 Sweden. 67 B.5 Switzerland . 67 B.6 United Kingdom 67 B.7 United States 67 Annex C (informative) Developing USABILITY GOALS for commercial purposes . 68 C.1 General . 68 C.2 Obj

22、ective goals . 68 C.3 Subjective goals 69 Annex D (informative) USABILITY ENGINEERING project end products . 71 Annex E (informative) USABILITY ENGINEERING methods . 73 E.1 General . 73 E.2 Advisory panel reviews 74 E.3 Brainstorm USE SCENARIOS . 75 E.4 Cognitive walkthrough . 75 E.5 Contextual inqu

23、iry . 75 E.6 Day-in-the-life analysis 76 E.7 Expert reviews 77 E.8 FMEA and FTA . 77 E.9 Focus groups 78 E.10 FUNCTION ANALYSIS 78 E.11 Heuristic analysis 79 E.12 Observation 79 E.13 One-on-one interviews 79 E.14 Participatory design 80 E.15 PCA analysis 80 E.16 SIMULATION 82 E.17 Standards reviews

24、. 82 E.18 Surveys 83 E.19 TASK ANALYSIS . 83 E.20 Time-and-motion studies . 84 E.21 Workload assessment . 84 Annex F (informative) USABILITY ENGINEERING studies in clinical settings . 85 F.1 General . 85 F.2 Sample study in the clinical environment . 85 Annex G (informative) USER PROFILE . 87 PD IEC

25、/TR 62366-2:2016IEC TR 62366-2:2016 IEC 2016 5 Annex H (informative) USE ENVIRONMENT descriptions . 89 Annex I (informative) USER INTERFACE REQUIREMENTS 91 Annex J (informative) Model the USER INTERFACE 92 J.1 General . 92 J.2 Develop preliminary prototype(s) . 92 J.3 Develop a refined prototype . 9

26、2 J.4 Develop a specification prototype 93 J.5 Prepare a style guide 93 Annex K (informative) USABILITY TEST sample size 94 Annex L (informative) Identifying distinct USER groups 97 Bibliography . 98 Index of defined terms 101 Figure 1 Example of a USABILITY ENGINEERING project for a graphical USER

27、INTERFACE 26 Figure 2 Progression of a USER INTERFACE design from multiple concepts to a few concepts to a preferred concept 46 Figure 3 Progression of concepts from multiple concepts to a few concepts to a preferred concept . 50 Figure E.1 Sample of a USE ENVIRONMENT within a hospital 76 Figure E.2

28、 Model of USER-MEDICAL DEVICE interaction 81 Figure E.3 Infant manikin used in a neonatal care unit simulator (left), test participant simulating an auto-injector (centre) and an adult manikin used in a surgery SIMULATION (right) . 82 Figure E.4 Example hierarchical TASK ANALYSIS . 84 Figure J.1 USE

29、R INTERFACE designers using prototyping software to build and test a USER INTERFACE . 93 Figure K.1 Number of test participants needed in a USABILITY TEST for FORMATIVE EVALUATION . 95 Table 1 Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2 14 Table 2 Human versus

30、machine capabilities . 34 Table 3 Example of five qualitative SEVERITY levels (adapted from Table D.3 of ISO 14971:2007) 39 Table 4 Example outline of a USABILITY TEST protocol 44 Table 5 Example outline of a USABILITY TEST report . 44 Table 6 USE ERRORS caused by sample USER INTERFACE design shortc

31、omings 55 Table 7 Sample USE ERRORS and their root causes 60 Table D.1 USABILITY ENGINEERING project end products 71 Table E.1 Recommended application of USABILITY methods . 74 Table G.1 Sample USER PROFILE . 87 Table H.1 Sample USE ENVIRONMENT . 89 Table I.1 Sample USER INTERFACE REQUIREMENTS 91 Ta

32、ble K.1 Cumulative probability of detecting a USABILITY problem 96 PD IEC/TR 62366-2:2016 6 IEC TR 62366-2:2016 IEC 2016 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL DEVICES Part 2: Guidance on the application of usability engineering to medical devices FOREWORD 1) The International Electrote

33、chnical Commission (IEC) is a worldwide organization 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 t

34、his end and in addition to other activities, IEC publishes International Standards, Technical 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 Nationa

35、l Committee interested in the subject dealt with may participate in this preparatory work. 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

36、) in accordance with conditions determined by agreement between the two organizations. 2) 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 fr

37、om all interested IEC National Committees. 3) IEC Publications have the form of recommendations 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 h

38、eld responsible for the way in which they are used or for any misinterpretation by any end 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

39、divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to

40、IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual

41、 experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this

42、IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this

43、IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. 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

44、 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 62366-2, which is a technical report, has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical equipment used in medi

45、cal practice, of IEC technical committee 62: Electrical equipment in medical practice, and technical committee ISO/TC 210: Quality management and corresponding general aspects for medical devices. It is published as a double logo standard. PD IEC/TR 62366-2:2016IEC TR 62366-2:2016 IEC 2016 7 The tex

46、t of this technical report is based on the following documents: Enquiry draft Report on voting 62A/1015/DTR 62A/1040A/RVC 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. In ISO, the standard has been approved

47、 by 23 P-members out of 36 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this Technical Report, the following print types are used. Guidance for the implementation of a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS required by

48、 IEC 62366-1:2015 and definitions): roman type. Additional information about USABILITY ENGINEERING best practices: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE

49、 3 OR AS NOTED: SMALL CAPITALS. A list of all parts in the IEC 62366, published under the general title Medical devices, can be found on the IEC website. This technical report is to be read in conjunction with IEC 62366-1:2015. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfir