Iec tr 62366 2 2016

I E C TR 62366-2 Edition 201 6-04 TE CH N I CAL R E POR T colour i n si de M ed i cal d evi ces – IEC TR 62366-2:201 6-04(en) Part 2: G u i d an ce on th e appl i cati o n o f u sabi l i ty en g i n eeri n g to m ed i cal d evi ces TH I S P U B L I C ATI O N I S C O P YR I G H T P R O TE C TE D C o p yri g h t © I E C , G e n e va , Sw i t z e rl a n d 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 3, rue de Varembé CH-1 21 Geneva 20 Switzerland Tel.: +41 22 91 02 1 Fax: +41 22 91 03 00 info@iec.ch www.iec.ch Abo u t th e I E C The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies Ab o u t I E C p u b l i c a t i o n s 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 I EC C atal og u e - webstore i ec ch /catal o g u e E l ectro ped i a - www el ectro ped i a org I EC pu bl i cati on s search - www i ec ch /search pu b I E C G l o ssary - s td i ec ch /g l ossary The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents Available for PC, Mac OS, Android Tablets and iPad The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,…) It also gives information on projects, replaced and withdrawn publications The world's leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in additional languages Also known as the International Electrotechnical Vocabulary (IEV) online More than 60 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002 Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR I EC J u st Pu bl i s h ed - webstore i ec ch /j u stp u bl i s h ed Stay up to date on all new IEC publications Just Published details all new publications released Available online and also once a month by email I E C Cu s to m er S ervi ce Cen tre - webstore i ec ch /csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch I E C TR 62366-2 Edition 201 6-04 TECH N I CAL R E POR T colour i n si de M ed i cal d evi ces – Part 2: G u i d an ce on th e appl i cati o n o f u sabi l i ty en g i n eeri n g to m ed i cal d evi ces INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 1 040.01 ISBN 978-2-8322-3346-7 Warn i n g ! M ake su re th at you obtai n ed th i s pu bl i cati on from an au th ori zed d i stri bu tor –2– I EC TR 62366-2:201 © I EC 201 CONTENTS FOREWORD I N TRODU CTI ON Scope and pu rpose 1 Scope Pu rpose N ormati ve references Terms an d defin i tions 1 M appi ng between th e requ i rem en ts of I EC 62366-1 and th e g ui dance of I EC TR 62366-2 Backg rou nd and ju sti ficati on of the U SABI LI TY EN G I N E ERI N G prog ram H ow SAFETY rel ates to U SABI LI TY Reasons to in vest in U SABI LI TY EN G I N EERI N G H ow to implement a U SABI LI TY EN G I N EERI N G prog ram 6 Effecti ve U SABI LI TY EN G I N EERI N G prog rams 6 Effecti ve U SABI LI TY EN G I N EERI N G projects and plans 6 Apply an appropriate l evel of U SABI LI TY EN G I N EERI N G expertise Ensu re th e n ecessary resou rces are avail able an d well timed R I SK M AN AG EM EN T as it rel ates to U SABI LI TY EN G I N EERI N G R I SK AN ALYSI S R I SK CON TROL I n form ati on for SAFETY 20 Overal l evalu ati on of RESI DU AL RI SK 22 6 U SABI LI TY EN G I N EERI N G FI LE 22 Tailori ng th e U SABI LI TY EN G I N EERI N G effort 23 Overview of th e U SABI LI TY EN G I N EERI N G PROCESS 24 Prepare the U SE SPECI FI CATI ON 27 I n i tiate U SE SPE CI FI CATI ON 27 An alyse the i n tended U SERS , an ticipated U SER TASKS and in tended U SE EN VI RON M EN TS 28 I n tended U SERS 28 2 An ticipated U SER TASKS 30 I n tended U SE EN VI RON M EN T 30 Finalize the U SE SPECI FI CATI ON 30 Recom men ded methods for devel oping the U SE SPECI FI CATI ON 31 General 31 Contextu al in qu iry and observation 31 I n tervi ew and su rvey tech niques 31 4 Expert reviews 32 Advisory pan el reviews 32 U SABI LI TY TESTS 32 I den ti fy U SER I N TERFACE ch aracteristics rel ated to SAFETY an d poten tial U SE ERRORS 32 General 32 T ASK AN ALYSI S 33 F U N CTI ON AN ALYSI S 33 I den ti fy and analyse known probl ems 35 I EC TR 62366-2:201 © I EC 201 –3– I den ti fy known or foreseeable H AZARDS and H AZARDOU S SI TU ATI ON S 35 I den ti fy an d describe H AZARD - RELATED U SE SCEN ARI OS 36 1 Define U SE SCEN ARI OS 36 1 U SE SCEN ARI OS as they relate to RI SK M AN AG EM EN T 36 1 I den ti fy H AZARD - RELATED U SE SCEN ARI OS 37 1 M eth ods to defi ne an d an alyse H AZARD - RELATED U SE SCEN ARI OS 37 Select th e H AZARD - RELATED U SE SCEN ARI OS for SU M M ATI VE EVALU ATI ON 38 General 38 2 Selection of th e H AZARD - RELATED U SE SCEN ARI OS based on SEVERI TY 39 Selection of H AZARD - RELATED U SE SCEN ARI OS based on other circu mstances 39 Establ ish U SER I N TERFACE SPECI FI CATI ON 40 Devel opment of the U SER I N TE RFACE SPECI FI CATI ON 40 A CCOM PAN YI N G DOCU M EN TATI ON and training 40 Establ ish U SER I N TERFACE EVALU ATI ON plan 41 Specify how th e U SER I N TERFACE desig n wi ll be explored and evalu ated 41 F ORM ATI VE EVALU ATI ON planning 42 S U M M ATI VE EVALU ATI ON plann ing 42 4 U SABI LI TY TEST planni ng 43 Example U SABI LI TY TEST protocol and report 43 Desig n and im plemen t the U SER I N TERFACE and trainin g 44 General 44 Devel op conceptu al model(s) 46 Desig n software U SER I N TERFACES (if appl icabl e) 47 General 47 Review U SER I N TERFACE REQU I RE M EN TS an d constrai n ts 47 3 Devel op software U SER I N TERFACE stru ctu re(s) 47 Desig n wireframes 48 5 Desig n screen tem plates 48 Desig n hardware U SER I N TERFACES (if appl icabl e) 48 General 48 Review U SER I N TERFACE REQU I RE M EN TS an d constrai n ts 49 Devel op concept sketch es 49 5 Desig n m aterials necessary for trainin g an d train in g 49 5 General 49 5 Train ing materi als 49 5 Training 51 Devel op detai led desig ns 52 Veri fy th e desig n of the U SER I N TERFACE 52 Perform FORM ATI VE EVALU ATI ON S 52 Condu ct mu ltiple FORM ATI VE EVALU ATI ON S 52 Recom men ded methods for FORM ATI VE EVALU ATI ON 53 General 53 2 Conduct heu ristic an alysis 54 Conduct cogn i ti ve walkthrou g h 54 Conduct U SABI LI TY TESTS 54 An alysis of FORM ATI VE EVALU ATI ON resu l ts 55 Perform SU M M ATI VE EVALU ATI ON 55 General 55 10 11 –4– I EC TR 62366-2:201 © I EC 201 Condu ct a SU M M ATI VE EVALU ATI ON 56 Data coll ection 57 General 57 Observati onal data 57 3 Su bjecti ve data 58 Data an al ysis 59 Docum en t the U SABI LI TY EN G I N EERI N G project 61 P OST - PRODU CTI ON review and anal ysis 61 An nex A (i nformative) Recommended readi ng list 64 An nex B (i nformative) External resou rces to identify known problems 66 B General 66 B Au stria 66 B Germ an y 66 B Sweden 67 B Switzerlan d 67 B U n ited Ki ng dom 67 B U n ited States 67 An nex C (in formati ve) Devel oping U SABI LI TY G OALS for com mercial pu rposes 68 C General 68 C Objecti ve g oals 68 C Su bjecti ve goals 69 An nex D (in formati ve) U SABI LI TY E N G I N EE RI N G project end products 71 An nex E (i nformative) U SABI LI TY EN G I N EERI N G m ethods 73 E General 73 E Advisory pan el reviews 74 E Brainstorm U SE SCEN ARI OS 75 E Cogn i ti ve walkth rou g h 75 E Con textu al inqu iry 75 E Day-in-the-l ife anal ysis 76 E Expert reviews 77 E FMEA an d FTA 77 E Focu s g rou ps 78 E F U N CTI ON AN ALYSI S 78 E 1 H euristic anal ysis 79 E Observati on 79 E One-on-one in tervi ews 79 E Participatory desig n 80 E PCA an al ysis 80 E S I M U LATI ON 82 E Standards reviews 82 E Su rveys 83 E T ASK AN ALYSI S 83 E 20 Time-and-motion stu dies 84 E 21 Workl oad assessmen t 84 An nex F (in formative) U SABI LI TY EN G I N EERI N G stu dies in cl in ical setting s 85 F General 85 F Sample stu dy i n th e clinical en vi ronm en t 85 An nex G (in formati ve) U SER PROFI LE 87 I EC TR 62366-2:201 © I EC 201 –5– An nex H (informati ve) U SE EN VI RON M EN T descriptions 89 An nex I (informative) U SER I N TERFACE REQU I REM EN TS 91 An nex J (in formati ve) Model the U SER I N TERFACE 92 J.1 General 92 J.2 Devel op prelim inary prototype(s) 92 J.3 Devel op a refined prototype 92 J.4 Devel op a specification prototype 93 J.5 Prepare a styl e g ui de 93 An nex K (i nformative) U SABI LI TY TEST sample size 94 An nex L (in formative) I dentifyin g disti nct U SER g rou ps 97 Bi bliog raph y 98 I n dex of defin ed terms 01 Fi gu re – Example of a U SABI LI TY EN G I N EERI N G project for a g raph ical U SER I N TERFACE 26 Fi gu re – Progression of a U SER I N TERFACE desig n from mu lti ple concepts to a few concepts to a preferred concept 46 Fi gu re – Progression of concepts from m ul tiple concepts to a few concepts to a preferred concept 50 Fi gu re E – Sample of a U SE EN VI RON M EN T within a hospital 76 Fi gu re E – M odel of U SER - M EDI CAL DEVI CE interaction 81 Fi gu re E – I n fant m an ikin u sed in a n eon atal care u ni t simu lator (left) , test partici pan t si mu l ating an au to-in jector (centre) an d an adu lt m an ikin u sed in a surgery SI M U LATI ON (rig h t) 82 Fi gu re E – Example h ierarch ical TASK AN ALYSI S 84 Fi gu re J – U SER I N TERFACE desig n ers usi ng prototypi ng software to bu ild and test a U SER I N TERFACE 93 Fi gu re K – N u mber of test participan ts needed in a U SABI LI TY TEST for FORM ATI VE EVALU ATI ON 95 Table – Mapping between th e requ irements of I EC 62366-1 and th e g u idance of I EC TR 62366-2 Table – H u man versu s m ach in e capabilities 34 Table – Example of fi ve qu ali tati ve SEVERI TY levels (adapted from Table D of I SO 4971 :2007) 39 Table – Example ou tline of a U SABI LI TY TEST protocol 44 Table – Example ou tline of a U SABI LI TY TEST report 44 Table – U SE ERRORS cau sed by sample U SER I N TERFACE desig n shortcoming s 55 Table – Sample U SE ERRORS and th ei r root cau ses 60 Table D – U SABI LI TY EN G I N EERI N G project end produ cts 71 Table E – Recom men ded appl ication of U SABI LI TY m ethods 74 Table G – Sample U SER PROFI LE 87 Table H – Sample U SE EN VI RON M EN T 89 Table I – Sample U SER I N TERFACE REQU I REM EN TS 91 Table K – Cu mu lative probabil ity of detecting a U SABI LI TY problem 96 –6– I EC TR 62366-2:201 © I EC 201 I NTERNATI ONAL ELECTROTECHN I CAL COMMI SSI ON MEDICAL DEVICES – Part 2: Guidance on the application of usability engineering to medical devices FOREWORD ) Th e I n tern ati on al El ectrotech n i cal Com m i ssi on (I EC) i s a worl d wi d e org an i zati on for stan dard i zati on com pri si n g al l n ati on al el ectrotech n i cal com m i ttees (I EC N ati on al Com m i ttees) Th e obj ect of I E C i s to prom ote i n tern ati on al co-operati on on al l q u esti on s cern i n g stan dard i zati on i n th e el ectri cal an d el ectron i c fi el ds To th i s en d an d i n ad di ti on to oth er acti vi ti es, I EC pu bl i sh es I n tern ati on al Stan d ards, Tech n i cal Speci fi cati on s, Tech n i cal Reports, Pu bl i cl y Avai l abl e Speci fi cati on s (PAS) an d G u i d es (h ereafter referred to as “I EC Pu bl i cati on (s) ”) Th ei r preparati on i s en tru sted to tech n i cal com m i ttees; an y I EC N ati on al Com m i ttee i n terested i n th e su bj ect d eal t wi th m ay parti ci pate i n th i s preparatory work I n tern ati on al , g overn m en tal an d n on g overn m en tal org an i zati on s l i si n g wi th th e I EC al so parti ci pate i n th i s preparati on I EC col l aborates cl osel y wi th th e I n tern ati on al Org an i zati on for Stan d ard i zati on (I SO) i n accordan ce wi th d i ti on s d eterm i n ed by ag reem en t between th e two org an i zati on s 2) Th e form al deci si on s or ag reem en ts of I EC on tech n i cal m atters express, as n earl y as possi bl e, an i n tern ati on al sen su s of opi n i on on th e rel evan t su bj ects si n ce each tech n i cal com m i ttee h as represen tati on from al l i n terested I EC N ati on al Com m i ttees 3) I EC Pu bl i cati on s h ave th e form of recom m en d ati on s for i n tern ati on al u se an d are accepted by I EC N ati on al Com m i ttees i n th at sen se Wh i l e al l reason abl e efforts are m ad e to en su re th at th e tech n i cal ten t of I E C Pu bl i cati on s i s accu rate, I EC can n ot be h el d respon si bl e for th e way i n wh i ch th ey are u sed or for an y m i si n terpretati on by an y en d u ser 4) I n ord er to prom ote i n tern ati on al u n i form i ty, I EC N ati on al Com m i ttees u n d ertake to appl y I EC Pu bl i cati on s tran sparen tl y to th e m axi m u m exten t possi bl e i n th ei r n ati on al an d reg i on al pu bl i cati on s An y di verg en ce between an y I EC Pu bl i cati on an d th e correspon d i n g n ati on al or reg i on al pu bl i cati on sh al l be cl earl y i n di cated i n th e l atter 5) I EC i tsel f d oes n ot provi d e an y attestati on of form i ty I n d epen d en t certi fi cati on bodi es provi d e form i ty assessm en t servi ces an d , i n som e areas, access to I EC m arks of form i ty I EC i s n ot respon si bl e for an y servi ces carri ed ou t by i n d epen d en t certi fi cati on bodi es 6) Al l u sers sh ou l d en su re th at th ey h ave th e l atest edi ti on of th i s pu bl i cati on 7) N o l i abi l i ty sh al l attach to I E C or i ts di rectors, em pl oyees, servan ts or ag en ts i n cl u di n g i n d i vi du al experts an d m em bers of i ts tech n i cal com m i ttees an d I EC N ati on al Com m i ttees for an y person al i n j u ry, property d am ag e or oth er d am ag e of an y n atu re wh atsoever, wh eth er di rect or i n d i rect, or for costs (i n cl u d i n g l eg al fees) an d expen ses ari si n g ou t of th e pu bl i cati on , u se of, or rel i an ce u pon , th i s I EC Pu bl i cati on or an y oth er I EC Pu bl i cati on s 8) Atten ti on i s d rawn to th e N orm ati ve referen ces ci ted i n th i s pu bl i cati on U se of th e referen ced pu bl i cati on s i s i n di spen sabl e for th e correct appl i cati on of th i s pu bl i cati on 9) Atten ti on i s d rawn to th e possi bi l i ty th at som e of th e el em en ts of th i s I EC Pu bl i cati on m ay be th e su bj ect of paten t ri g h ts I EC sh al l n ot be h el d respon si bl e for i d en ti fyi n g an y or al l su ch paten t ri g h ts The main task of I EC tech nical commi ttees is to prepare I n ternational Standards H owever, a techn ical com m ittee may propose th e pu bl ication of a techn ical report wh en it has collected data of a differen t kin d from th at wh ich is normall y pu blished as an I nternational Standard, for exam pl e "state of th e art" I EC 62366-2, wh ich is a techn ical report, has been prepared by a joint worki ng g rou p of su bcomm i ttee 62A: Comm on aspects of electrical equ ipm ent u sed i n medical practice, of I EC techn ical com m i ttee 62: Electrical equi pmen t in m edical practice, an d techn ical com m ittee I SO/TC 21 0: Qu ali ty manag emen t and correspondin g g eneral aspects for m edical devices I t is pu bl ish ed as a dou ble log o standard I EC TR 62366-2:201 © I EC 201 –7– The text of th is techn ical report is based on the fol lowing docu ments: En q u i ry d raft Report on voti n g 62A/1 01 5/DTR 62A/1 040A/RVC Fu ll in formati on on the votin g for the approval of th is technical report can be fou nd in th e report on voti ng indicated in th e above table I n I SO, the standard has been approved by 23 P-m embers ou t of 36 h aving cast a vote Th is pu blication has been drafted in accordance wi th the I SO/I EC Directi ves, Part I n this Technical Report, th e foll owing prin t types are u sed – – – – Gui dance for the implemen tation of a U SABI LI TY EN G I N EERI N G ( H U M AN FACTORS PROCE SS requ ired by I EC 62366-1 :201 and defini ti ons) : rom an type Additional information about USABILITY ENGINEERING best practices: italic type EN G I N EERI N G ) I n form ati ve m ateri al appeari n g ou tsi d e of tabl es, su ch as n otes, exam pl es an d referen ces: i n sm al l er type Text of tabl es i s al so i n a sm al l er type T ERM S DE FI N ED I N C LAU SE OR AS N OTED : SM ALL CAPI TALS A li st of all parts in the I EC 62366, pu blished u n der the general title Medical devices, can be fou nd on th e I EC website Th is techn ical report is to be read in conju nction with I EC 62366-1 :201 The com mi ttee h as decided that th e ten ts of this pu blication wil l remain unchan g ed u n til th e stabil ity date in dicated on th e I EC websi te u nder "http://webstore iec ch " in the data related to the specific pu bl ication At th is date, the publ ication wil l be • recon firmed, • wi thdrawn , • replaced by a revised edi ti on, or • amended A bilingu al versi on of this publicati on m ay 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 –8– I EC TR 62366-2:201 © I EC 201 I NTRODUCTI ON Th is techn ical report provides M EDI CAL DEVI CE M AN U FACTU RERS wi th g u idance on how to i n tegrate U SABI LI TY EN G I N EERI N G (also cal led H U M AN FACTORS EN G I N EERI N G ) principles and U SER I N TERFACE desig n practices in to their overall M EDI CAL DEVI CE developmen t PROCESSES The technical report recog n izes that all M EDI CAL DEVI CES in vol ving h um an in teracti on presen t opportu ni ties for optim ization th roug h th e appl ication of U SABI LI TY EN G I N EERI N G and seeks to g ui de th e M EDI CAL DEVI CE M AN U FACTU RERS efforts Th is report concerns the qual ity of U SER in teractions wi th M EDI CAL DEVI CES th at are as varied as acqu iring in formation on a display, pressing a ph ysical bu tton or on -screen tou ch targ et bu tton, selecting items on a software men u , attachi ng ACCESSORI ES to a M EDI CAL DEVI CE and in terpretin g warning s as wel l as u nderstanding relevan t aspects for the proper u se of the M EDI CAL DEVI CE by reading the ACCOM PAN YI N G DOCU M EN TATI ON U SABI LI TY EN G I N EERI N G prog rams, if properl y implemen ted, can increase the likel ihood that U SERS are able to perform such actions correctl y and wi th ou t hindrance M edical practice is increasi ng l y u sin g M EDI CAL DEVI CES for observation an d treatmen t of cau sed by in adequ ate M EDI CAL DEVI CE U SABI LI TY have become an i ncreasing cause for concern M any of the M EDI CAL DEVI CES developed wi thou t appl yin g a U SABI LI TY EN G I N EERI N G PROCESS are n on-in tu itive, di fficu lt to learn and di fficu lt to u se I n addi tion , M EDI CAL DEVI CES developed withou t appl yin g U SABI LI TY EN G I N EERI N G or developed wi th incomplete or inadequ ate appl ication of U SABI LI TY E N G I N EE RI N G can i ncl u de design sh ortcomings that can l ead to U SE ERRORS , particu larly wi th varied U SERS and U SE EN VI RON M EN TS , wh ich can lead to H ARM PATI EN TS U SE ERRORS As h eal thcare evol ves, l ess skil led U SERS including PATI EN TS themsel ves are now u si ng M EDI CAL DEVI CES an d M EDI CAL DEVI CES are becoming m ore com pli cated Wh ile M EDI CAL DEVI CES become increasi ng l y sophisti cated, they can be more l ikel y to indu ce U SE ERRORS I f n ot properly design ed or safeg uarded, M EDI CAL DEVI CES cou ld tribu te to H AZARDOU S SI TU ATI ON S and can be a source of H ARM An appropriate-tai lored in vestm en t in U SABI LI TY EN G I N EERI N G ensu res that M EDI CAL DEVI CES wi ll have acceptable RI SK and U SABI LI TY and th at desi gn shortcom ing s are i denti fied an d removed from the U SER I N TERFACE Accordin gl y, this techn ical report emph asizes the im portance of desig nin g for U SABI LI TY , wi th an emphasis placed on ensu ring SAFETY Ascribing to th is report hel ps M AN U FACTU RERS respond effecti vel y to regu latory expectations th at call for th e application of U SABI LI TY EN G I N EERI N G du ri ng th e M EDI CAL DEVI CE development PROCESS I t also helps M AN U FACTU RERS produ ce M EDI CAL DEVI CES th at h ave wel l desig n ed U SER I N TERFACES that satisfy U SERS As such , i t can propel a M AN U FACTU RER beyond a comm on sense approach to U SE R I N TERFACE desi gn to an approach that fu lly embraces U SABI LI TY EN G I N EERI N G as an essen tial step toward desig n excel lence Oth er ben eficiari es of th is docu m en t's gu idance inclu de au thorities havin g ju risdiction (AH J ) an d M EDI CAL DEVI CE consu mers wh o share a common interest in safe and effecti ve M EDI CAL DEVI CES The g u idance provided in this report applies to all M EDI CAL DE VI CES , inclu din g those u sed by laypersons and/or heal thcare professionals; M EDI CAL DEVI CES that perform just one fu nction and those th at perform m an y functions; U SER I N TERFACES in the form of hardware, software, docu men tation , and packag ing ; M EDI CAL DEVI CES th at fit i n a pocket, sit on a tabl e, ride on a cart, or fill a room ; an d M EDI CAL DEVI CES th at requ ire no prior operati onal kn owl edg e or cal l for traini ng before u se According ly, i t applies to a pen i njector, g lucose m eter, in fu sion pu m p, PATI EN T mon i tor, anaesth esi a workstation , and radi ation therapy system , just to name a few M EDI CAL DEVI CES – 90 – Ta b l e H I EC TR 62366-2:201 © I EC 201 (2 of 2) I n t e n s i ve C a r e U n i t Ph otos IEC Cen tral workstati on (l eft) an d i n ten si ve care u n i t bay (ri g h t) IEC I EC TR 62366-2:201 © I EC 201 – 91 – Annex I (informative) U SER INTERFACE REQUIREMENTS U SER are derived from U SER needs and are used to prescribe a U SER hum an factors desig n principles, such as those fou nd in standards and textbooks Presu mably, developm ent teams treat U SE R I N TERFACE REQU I REM EN TS in th e same m ann er as oth er requ iremen ts, su ch as th ose establ ish ed for power systems, electronic ci rcu its, an d software code I N TERFACE REQU I REM EN TS I N TERFACE desig n that meets Sample U SER I N TERFACE REQU I REM E N TS are tained in Table I Table I.1 – Sample USER INTERFACE REQUIREMENTS U SER INTERFACE element Con trol pan el bu tton s Expressed USER need U SER INTERFACE REQUIREMENT Bu tton s sh ou l d be l arg e en ou g h so th at you d o n ot h i t th e wron g on e acci den tal l y Con trol pan el bu tton s sh ou l d be at l east , cm tal l an d wi d e Con trol pan el bu tton s sh ou l d be spaced at l east cm apart (m easu red cen tre-to-cen tre) Di spl ay I wou l d l i ke th e m ost i m portan t param eters to stan d ou t so I can read th em from a di stan ce Pri m ary treatm en t param eters sh al l be l eg i bl e from a d i stan ce of m (i e across th e room ) H an d l e I wou l d l i ke th e su rg i cal i n stru m en t’ s h an d l e to fi t m y sm al l h an d U S ER S M en u opti on s I t wou l d be g ood i f th e cu rren tl y sel ected m en u i tem was h i g h l i g h ted i n som e way or an oth er to be d i sti n ct H i g h l i g h t th e cu rren tl y sel ected opti on i n a l i st of opti on s On -screen i n form ati on I wan t to be abl e to tel l th e d i fferen ce ri g h t away between i n form ati on th at I am j u st su pposed to read versu s d o som eth i n g wi th Di fferen ti ate read -on l y d i spl ays from those th at al l ow U SE R S to ed i t d ata On -screen i n form ati on I wou l d l i ke to l ook at th e screen an d see h ow m u ch m ore ti m e i s l eft i n th e treatm en t Th e treatm en t ti m e rem n i n g sh al l be di spl ayed ti n u ou sl y on th e m n m on i tori n g screen (th e resti n g screen th at appears wh i l e th e eq u i pm en t i s ru n n i n g i n d epen d en tl y) Packag e pu l l -tab I t sh ou l d be obvi ou s h ow to open th e ou ter pl asti c packag e to access th e tu bi n g set Th e ou ter packag e sh ou l d h ave a l arg e, vi su al l y spi cu ou s pu l l tab Qu i ck referen ce card I d o n ot l i ke to h ave to read l on g i n stru cti on s for u se to l earn abou t th e basi c steps I prefer to ski m a card th at bri efl y an d g raph i cal l y tel l s m e wh at I n eed to kn ow A q u i ck referen ce card sh ou l d i n stru ct U SE RS h ow to perform freq u en t an d i m portan t TAS KS I d o n ot l i ke to h ave to scrol l down l on g l i sts I t takes u p ti m e an d i s an n oyi n g Presen t at l east fou r m en u opti on s at a ti m e on a scrol l i n g m en u Scrol l i n g m en u s Th e h an d l e sh al l accom m odate wi th vari ou s si ze h an d s (ran g i n g from th e fi rst-percen ti l e fem al e to th e n i n ety-n i n th percenti l e m al e i n term s of h an d l en g th an d bread th ) A q u i ck referen ce card sh ou l d provi d e i n stru cti on s i n both g raph i cal an d textu al form s – 92 – I EC TR 62366-2:201 © I EC 201 Annex J (informative) Model the USER INTERFACE J.1 General Best USABILITY ENGINEERING practice calls for the early and frequent participation of end-USERS in the USER INTERFACE design PROCESS Building a series of increasingly sophisticated USER INTERFACE models as a design evolves from the preliminary to near-final stage is an essential step toward meeting this goal Moreover, many USER INTERFACE designers find that they well to build prototypes as they design, enabling them to get a feel for a USER INTERFACE’S dynamic characteristics and adjust them as needed J.2 Develop preliminary prototype(s) An early USER INTERFACE prototype can take several forms depending on whether it is a hardware device, software application, or hybrid MEDICAL DEVICE’S incorporating a software USER INTERFACE (e.g PATIENT monitors, infusion pumps, glucose meters) can be presented in the form of a paper-based “storyboard” or a computer-based slideshow (e.g slide presentation), perhaps complemented by a non-working hardware model (i.e what industrial designers call a block model) A computer-based slideshow enables the MANUFACTURER to incorporate some dynamic effects, such as moving between screens in response to selecting onscreen targets and dynamically updating certain onscreen information Hardware-only MEDICAL DEVICES are readily presented to USERS in the form of the aforementioned block models, which might be hand-made using high-density foam or wood or 3-D printed Noting that limited prototypes, such as those described above, are usually adequate to serve their intended purpose, MANUFACTURERS might find it just as easy to produce higher FIDELITY prototypes Building better (i.e higher FIDELITY) prototypes can produce better results, but care needs to be taken to ensure that the development team does not exclude considering any promising design options prematurely because the prototyping effort would be too expensive J.3 Develop a refined prototype As a design matures, the prototypes usually too, typically taking the form of increasingly interactive electronic prototypes (i.e computer-based SIMULATIONS) and physical models that might have some working parts The advantage of using a modelling tool (e.g Adobe Flash, Microsoft PowerPoint, Microsoft Visual Basic) as opposed to the final development tool is that it usually speeds up the prototyping effort and enables rapid design iteration without concern for discarding software code that took a lot of programming effort Figure J.1 demonstrates software prototyping of a USER INTERFACE As a design becomes more refined, prototype refinement should keep up to support effective design reviews and USABILITY TESTS For example, refined prototypes might have more advanced capabilities such as: – – – – – fully functional menus; automatically updating data fields; carefully timed transitions from screen to screen; virtual hardware controls that switch position; and accurate auditory ALARM SIGNALS I EC TR 62366-2:201 © I EC 201 – 93 – IEC Figure J.1 – U SER INTERFACE designers using prototyping software to build and test a USER INTERFACE J.4 Develop a specification prototype Near the end of the software USER INTERFACE development PROCESS, the MANUFACTURER can abandon SIMULATION in favour of having USERS interact with and provide feedback on a working version of the actual software that is embedded in representative hardware However, there might still be considerable value in building a specification prototype that illustrates the final design’s appearance and interactive characteristics Such prototypes can be an excellent asset, enabling MANUFACTURERS to view USER INTERFACES as the designers intend them to look and function, and reducing the chance that the concept is misinterpreted or details that are difficult to communicate in writing alone are overlooked J.5 Prepare a style guide A style guide can be an effective means to document the rules governing a particular USER INTERFACE design effort Its purpose is to promote USER INTERFACE design consistency in altogether new designs and future modifications to them Style guide content can include: – – – – – – – – – – – – – design rationale; CONCEPTUAL MODEL DIAGRAM and description; USER INTERFACE structure diagram and description; software USER INTERFACE design rules and examples; screen templates; dynamic effect descriptions; hardware USER INTERFACE design rules and examples; control panel layouts; USER support and feedback rules; font types and sizes; colour palette; icon/symbol library; and nomenclature (i.e standard terminology) – 94 – I EC TR 62366-2:201 © I EC 201 Annex K (informative) U SABILITY TEST sample size Th is An nex describes considerati ons for selecting sampl e si ze for U SABI LI TY TESTS I t depicts sample size recom mendations in both g raph ical and table based forms Th e main perspective is to show th e basis for sample size for U SABI LI TY TESTS for FORM ATI VE EVALU ATI ON , bu t also to offer rationalization for test sample size for U SABI LI TY TESTS for SU M M ATI VE EVALU ATI ON Table K sh ows g raphicall y the exponen ti al decrease of th e cu mu lati ve probabi li ty of detected problems as the n umber of participan ts i ncreases wh en sample size is g reater than Ann ex L provides addi tion al in form ation for iden tifyin g disti nct U SER G ROU PS N OTE M AN U FACTU R E RS are d i scou rag ed U S ABI LI TY TE STI N G an d th e resu l ti n g d ata are from perform i n g power an al yses to d eterm i n e sam pl e si zes becau se n ot parti cu l arl y wel l su i ted to stati sti cal an al yses Rath er, th e stan d ard practi ce i s to exam i n e al l test fi n di n g s to d eterm i n e i f th ere i s a n eed for d esi g n i m provem en t, di sreg ard i n g th e stati sti cal si g n i fi can ce of even ts (e g U S E E RRORS ) An other benefit of i terative desi gn is that m ul tiple roun ds of FORM ATI VE EVALU ATI ON effecti vel y increase cum u lati ve sam ple size an d fidence in detectin g U SABI LI TY defects The i terati ve i m provements in desi g n throug h FORM ATI VE EVALU ATI ON S are anoth er ju sti fication for smal ler SU M M ATI VE EVALU ATI ON sample sizes One example of performing a qu antitative U SABI LI TY TEST for FORM ATI VE EVALU ATI ON i s a test th at compares two or more alternative desig ns (e g displ ay type or ALARM SI G N ALS ) I n this case, a l arger sample size wi th the statistical power to detect U SER performance differences can be needed to m ake rel iable design al tern ative decisions Table K il lu strates the probability of observing at l east one instance of a U SE ERROR as a fu nction of sample size an d u n derl ying popu l ation U SE ERROR rates The u n derl ying popu l ation U SE ERROR rate can n ever be kn own and has to be estimated This table i s an adapti on of a sim ilar table AAM I H E75 [4] Th e principles apply to sample sizes for U SABI LI TY TESTS for both FORM ATI VE an d SU M M ATI VE EVALU ATI ON S Table K was g en erated from Equati on (K ) R = – (1 – P) n (K ) wh ere R i s th e cu mu lative probabil ity of observin g or detectin g a U SABI LI TY problem (see Fi gu re K ) , P i s the probability of a sing l e test partici pan t h aving a U SABI LI TY problem (or th e u nderlyi ng U SABI LI TY defect probability) , an d n is the nu mber of test participants i n th e evalu ation I EC TR 62366-2:201 © I EC 201 – 95 – ,0 0, 0, 0, R 0, 0, 0, 0, 0, 0, 1 10 15 20 N IEC Key R Cu m u l ati ve probabi l i ty of d etecti n g a U S ABI LI TY probl em N N u m ber of test parti ci pan ts i n th e eval u ati on N OTE R i s g en erated from Eq u ati on (K ) As sh own , i t u ses th e u n d erl yi n g probabi l i ty of a si n g l e U S ABI LI TY TE ST parti ci pan t sh owi n g a U S ABI LI TY probl em , P , of 0, 25 Figure K.1 – Number of test participants needed in a USABILITY TEST for FORMATIVE EVALUATION Table K i llustrates h ow sm all sam ple sizes can be used satisfactori ly to iden ti fy U SABI LI TY defects I t sh ows th e cu m u lati ve probabil i ty of a U SABI LI TY defect (the instance of a U SE ERROR bei ng commi tted) bein g detected i n a U SABI LI TY TEST , g iven th e u nderl yin g probabi li ty th at a sing le test participant woul d show a particu lar problem for a g iven TASK This tabl e applies to al l kin ds of popu lations and types of U SABI LI TY TESTS For example, if th e u n derl ying (assu med tru e popu lati on valu e) probabi l ity of a sing le test participant having a U SABI LI TY probl em is 0, 25, th en th e cu mu lative probabi li ty of detection is 0, 82 with six test partici pan ts Agai n, m an y U SABI LI TY defects can be discovered in FORM ATI VE EVALU ATI ON S wi th sam pl e sizes in the rang e of five to eig h t participan ts Wh en sam ple size reaches 5, th e probabi li ty of detecting at least one occu rrence of a U SABI LI TY defect increases to 0, 91 if the u nderl ying probabi li ty for one participan t is as low as 0, The m ain poin t of th is tabl e is not to su gg est th at larg e sample sizes of 00 are al ways needed for U SABI LI TY TESTS , bu t on ly that th ere are trade-offs – 96 – I EC TR 62366-2:201 © I EC 201 th at n eed to be consi dered wh en u sing various sample sizes Fu rther consi derations on th e u se of statistics for determ in ing U SABI LI TY TEST sam ple size can be found in Ann ex A of AAM I H E75:2009 [4] as wel l as references [30], [41 ], [42] and [43] N OTE At l east on e AH J recom m en ds i n cl u d i n g parti ci pan ts per di sti n ct U S E R G R OU P i n a U S ABI LI TY TE ST for SU M M ATI VE E VALU ATI ON [44] Tab l e K – C u m u l at i ve p ro ba b i l i t y o f d et ec t i n g a U S AB I L I T Y p ro b l e m Val u es i n % N u m ber o f test parti ci pan ts U S AB I L I TY d efect pro babi l i ty 1 20 25 50 75 00 ,0 10 14 18 22 39 53 63 3, 14 17 19 22 26 37 46 53 78 90 95 5, 10 14 23 26 30 34 40 54 64 72 92 98 99 10 10 19 27 41 47 52 57 65 79 88 93 99 00 00 15 15 28 39 56 62 68 73 80 91 96 98 00 00 00 25 25 44 58 76 82 87 90 94 99 00 00 00 00 00 50 50 75 88 97 98 99 00 00 00 00 00 00 00 00 75 75 94 98 00 00 00 00 00 00 00 00 00 00 00 90 90 99 00 00 00 00 00 00 00 00 00 00 00 00 of o ccu rren ce I EC TR 62366-2:201 © I EC 201 – 97 – Annex L (informative) Identifying distinct USER groups A U SABI LI TY TEST cal ls DEVI CE Test planners for a sample of representati ve U SERS to interact wi th a g iven M EDI CAL need to select a sam pl e th at yi el ds h ig h-qu ali ty findin g s wh i le being l im i ted in size to save resources Because the sam ple of represen tati ve U SE RS shou ld i ncl ude al l in tended U SER g rou ps, M EDI CAL DEVI CE M AN U FACTU RERS need to determin e th e nu mber of distinct U SER populations for a g iven M EDI CAL DEVI CE before determ ining how m an y represen tative U SERS to eng ag e in a U SABI LI TY TEST Ann ex K tains addi tion al in form ation reg ardin g sample sizes A test planner m ig h t conclu de that al l M EDI CAL DEVI CE U SERS fi t i nto one distinct U SER popu lation : people wh o use the g iven M EDI CAL DEVI CE I n some cases, this conclu sion mi g ht reflect the desire to conduct the smallest, least expensi ve U SABI LI TY TEST rather than a larg er, more expensi ve U SABI LI TY TEST th at reflects the tru e diversity of i n tended M EDI CAL DEVI CE U SERS More often , a U SER popu lation has several su b-popu lations that are easy to di fferen tiate wh en consideri ng the i n tended U SERS ’ occu pation al backg rounds, expected kn owl edg e and ski ll levels, and M EDI CAL DEVI CE use patterns Sample U SER grou ps (su bpopu lations) associated wi th variou s types of M EDI CAL DEVI CES inclu de the fol lowin g EXAM PLE 1 U S ER G R OU P : trai n ed ph ysi ci an s; EXAM PLE 2 U S ER G R OU P S : trai n ed n u rses, u n trai n ed n u rses; E XAM PLE 3 U S ER G R OU P S : asym ptom ati c ad u l ts, sym ptom ati c ad u l ts, l ay careg i vers; E XAM PLE 4 U S ER G R OU P S : ph ysi ci an s, n u rses worki n g i n h i g h acu i ty setti n g s (e g i n ten si ve care u n i ts) , n u rses worki n g i n l ow-acu i ty setti n g s (e g m ed i cal /su rg i cal u n i ts) , PATI E N TS ; EXAM PLE 5 U S ER G R OU P S : ch i l d, adol escen t, adu l t, el d erl y, h eal th care professi on al ( PATI EN T edu cator) ; an d EXAM PLE 6 U S E R G R OU P S : ad u l ts wi th n o i m pai rm en ts, ad u l ts wi th vi su al i m pai rm en ts, ad u l ts wi th h eari n g i m pai rm en ts, ad u l ts wi th d exteri ty i m pai rm en ts, ad u l ts wi th m i l d cog n i ti ve i m pai rm en ts, l ay careg i vers The U SER PROFI LES developed earl y in the U SABI LI TY EN G I N E ERI N G prog ress can be used to su pport U SER G ROU P defi n ition decisions for U SABI LI TY TE STI N G – 98 – I EC TR 62366-2:201 © I EC 201 Bibliography [1 ] I EC 60601 -1 -8:2006, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems I EC 60601 -1 -8:2006/AMD1 :201 [2] I EC 60601 -1 -1 , Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [3] I SO/TR 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