BS-EN-62366-2008.pdf
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1、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 reprodu
2、ction 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 entruste
3、d 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
4、 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 E
5、N 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 EUROPENNE EURO
6、PISCHE NORM January 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form a
7、nd 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 mdicaux - Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux (CE
8、I 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
9、 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
10、, 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, Bel
11、gium, 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
12、 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 62
13、366, 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 I
14、EC-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 st
15、andards 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). Se
16、e 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 smalle
17、r 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 Stand
18、ards 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 definition
19、s .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
20、 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 * U
21、SABILITY 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
22、 (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 wi
23、th 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 A
24、nnex 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
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