BS-EN-62366-2008.pdf

BRITISH STANDARD BS EN 62366:2008 Medical devices Application of usability engineering to medical devices ICS 11.040.01 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 62366:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2008 © BSI 2008 ISBN 978 0 580 54371 5 National foreword The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/1, 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 application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments This British Standard is the UK implementation of EN 62366:2008. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD EN 62366 NORME EUROPÉENNE EUROPÄISCHE NORM January 2008 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels © 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62366:2008 E ICS 11.040 English version Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux (CEI 62366:2007) Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366:2007) This European Standard was approved by CENELEC on 2007-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword The text of document 62A/574/FDIS, future edition 1 of IEC 62366, prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice and ISO/TC 210, Quality management and corresponding general aspects for medical devices, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62366 on 2007-12-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-12-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directives MDD (93/42/EEC) and IVD (98/79/EC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roman type. Means to assess compliance: 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 OR AS NOTED: SMALL CAPITALS. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62366:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 62366:2008 2 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- CONTENTS INTRODUCTION.5 1 * Scope 6 2 Normative references .6 3 Terms and definitions .6 4 * Principles.10 4.1 General requirements10 4.1.1 * USABILITY ENGINEERING PROCESS10 4.1.2 RESIDUAL RISK10 4.1.3 Information for SAFETY.11 4.2 * USABILITY ENGINEERING FILE.11 4.3 Scaling of the USABILITY ENGINEERING effort11 5 * USABILITY ENGINEERING PROCESS.11 5.1 * Application specification11 5.2 * Frequently used functions .12 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY12 5.3.1 Identification of characteristics related to SAFETY.12 5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS.13 5.4 PRIMARY OPERATING FUNCTIONS13 5.5 * USABILITY SPECIFICATION14 5.6 USABILITY VALIDATION plan14 5.7 * USER INTERFACE design and implementation15 5.8 * USABILITY VERIFICATION15 5.9 * USABILITY VALIDATION.16 6 * ACCOMPANYING DOCUMENT16 7 * Training and materials for training17 Annex A (informative) General guidance and rationale.18 Annex B (informative) Categories of USER action30 Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes.32 Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS35 ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETY.59 ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS63 Annex G (informative) USABILITY goals: Illustrative example for a home parenteral infusion pump .66 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 76 Annex I (informative) Recommended reading list .86 Annex J (informative) Reference to the essential principles .94 BS EN 62366:2008 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications .99 ANNEX ZZ (informative) Coverage of Essential Requirements of EC Directives .100 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- Figure A.1 A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366) 23 Figure B.1 Categories of foreseeable USER action31 Figure D.1 A USER INTERFACE design cycle .38 Figure D.2 Bubble diagram of the conceptual model of a physiological monitor51 Figure F.1 Pictorial representation of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM64 Table D.1 Sample of design flaws and associated USE ERRORS36 Table D.2 Mapping of Figure D.1 to the subclauses of this International Standard .38 Table D.3 Examples of USER INTERFACE requirements 41 Table D.4 Typical deliverables .46 Table D.5 Examples of objective USABILITY goals .49 Table D.6 Examples of subjective USABILITY goals49 Table D.7 Examples of USER INTERFACE modelling techniques 52 Table D.8 Characteristics of a typical USABILITY testing effort .52 Table F.1 Glossary of relevant RISK MANAGEMENT terms .63 Table F.2 Examples of HARM due to USABILITY related HAZARDS.64 Table G.1 Power on/off 69 Table G.2 Program pump.69 Table G.3 Start/stop infusion70 Table G.4 Monitor infusion status.71 Table G.5 Install and change set71 Table G.6 Priming72 Table G.7 Respond to and inactivate ALARM SIGNALS a72 Table G.8 Lockouts73 Table G.9 Power management.73 Table G.10 Preventative and routine maintenance .74 Table G.11 Basic operation75 Table G.12 Advanced functions .75 Table J.1 Correspondence between this document and the essential principles .94 BS EN 62366:2008 4 Bibliography96 Index of defined terms 97 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- INTRODUCTION Medical practice is increasingly using MEDICAL DEVICES for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL DEVICE USABILITY have become an increasing cause for concern. Many of the MEDICAL DEVICES developed without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled USERS including PATIENTS themselves are now using MEDICAL DEVICES and MEDICAL DEVICES are becoming more complicated. In simpler times, the USER of a MEDICAL DEVICE might be able to cope with an ambiguous, difficult-to-use USER INTERFACE. The design of a usable MEDICAL DEVICE is a challenging endeavour, yet many organizations treat it as if it were just “common sense”. The design of the USER INTERFACE to achieve adequate (safe) USABILITY requires a very different skill set than that of the technical implementation of that interface. The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USABILITY, which in turn is intended to minimise USE ERRORS and to minimise use-associated RISKS. Some, but not all, forms of incorrect use are amenable to control by the MANUFACTURER. The USABILITY ENGINEERING PROCESS is related to the RISK MANAGEMENT PROCESS as indicated in Figure A.1. This International Standard describes a USABILITY ENGINEERING PROCESS, and provides guidance on how to implement and execute the PROCESS to provide SAFETY in MEDICAL DEVICES. It is intended to be useful not only for MANUFACTURERS of MEDICAL DEVICES, but also for technical committees responsible for the preparation of particular MEDICAL DEVICE standards. BS EN 62366:2008 5 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- MEDICAL DEVICES APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES 1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE Informative references are listed in the bibliography beginning on page 96. ISO 14971:2007, Medical devices Application of risk management to medical devices 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 14971:2007 and the following apply. NOTE An index of defined terms is found beginning on page 98. 3.1 ABNORMAL USE intentional act or intentional omission of an act by the RESPONSIBLE ORGANIZATION or USER of a MEDICAL DEVICE as a result of conduct that is beyond any further reasonable means of RISK CONTROL by the MANUFACTURER NOTE 1 See also 4.1.3 and Annex B. Examples are given in Annex C. NOTE 2 It is possible for the PATIENT to be the USER, e.g. when the MEDICAL DEVICE is used in the PATIENTS home. 3.2 ACCOMPANYING DOCUMENT document accompanying a MEDICAL DEVICE and containing information for those accountable for the installation, use and maintenance of the MEDICAL DEVICE or the USER, particularly regarding SAFETY ISO 14971:2007, definition 2.1, modified BS EN 62366:2008 6 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:38:01 MDTNo reproduction or networking permitted without license from IHS -,-,- 3.3 ALARM LIMIT threshold used by an ALARM SYSTEM to determine an ALARM CONDITION IEC 60601-1-8:2006, definition 3.3 NOTE This term is only used in notes and informative annexes. 3.4 ALARM OFF state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not generate ALARM SIGNALS IEC 60601-1-8:2006, definition 3.4 NOTE This term is only used in notes and informative annexes. 3.5 ALARM SIGNAL type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION IEC 60601-1-8:2006, definition 3.9 NOTE This term is only used