IEC 62366 AMD 1-2014 Medical devices - Application of usability engineering to medical devices Amendment 1《医疗器械 医疗使用性工程的应用》.pdf

1、 IEC 62366 Edition 1.0 2014-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux IEC62366:2007-10/AMD1:2014-01(EN-FR)AMENDMENT 1 AMENDEMEN

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19、sc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 62366 Edition 1.0 2014-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical devices Application of usability engineering to medical devices Dispositifs mdicaux Applicat

20、ion de lingnierie de laptitude lutilisation aux dispositifs mdicaux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE G ICS 11.040 PRICE CODE CODE PRIX ISBN 978-2-8322-1134-2 Warning! Make sure that you obtained this publication from an authorized distributor. Atte

21、ntion! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. AMENDMENT 1 AMENDEMENT 1 2 62366 Amend.1 IEC:2014 FOREWORD This amendment has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practi

22、ce, of IEC technical committee 62: Electrical medical equipment in medical practice and technical committee ISO/TC 210: Quality management and corresponding general aspects for medical devices. The text of this amendment is based on the following documents: FDIS Report on voting 62A/889/FDIS 62A/897

23、/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 23 P-members out of 23 having cast a vote. The committee has decided that the contents of this amendment and the base pu

24、blication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. _ INTRODUCTION TO THE AMENDME

25、NT The first edition of IEC 62366 was published in 2007. This amendment is intended to add urgently needed requirements to deal with legacy devices for which the user interface design is of unknown provenance. Work is continuing in parallel to develop the second edition of IEC 62366. FOREWORD Add th

26、e following note at the end of the Foreword: NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make products in acc

27、ordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication. INTRODUCTION Add aft

28、er the last paragraph of the introduction the following paragraph: 62366 Amend.1 IEC:2014 3 Amendment 1 updates the standard to add urgently needed requirements to deal with legacy devices where the USER INTERFACE design is of unknown provenance. 2 Normative references In the existing introductory p

29、aragraph, replace the first sentence with: The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 3 Terms and definitions Add the following new definition: 3.27 USER INTERFACE OF UNKNOWN PROVENANCE UOUP USER INTERFACE or p

30、art of a USER INTERFACE of a MEDICAL DEVICE previously developed for which adequate RECORDS of the USABILITY ENGINEERING PROCESS of this standard are not available 5 USABILITY ENGINEERING PROCESS Add the following new subclause: 5.10 * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) Instead of all of th

31、e requirements of 5.1 through 5.9, UOUP may be evaluated according to Annex K. Compliance is checked by application of Annex K. Annex A General guidance and rationale A.2 Rationale for requirements in particular clauses and subclauses Add, after the existing paragraph of the rationale for Clause 7,

32、the following new rationale. Subclause K.2.1 Application specification The application specification is the essential source used to identify the most important characteristics related to the use of a MEDICAL DEVICE. When evaluating a USER INTERFACE including UOUP, the ACCOMPANYING DOCUMENTS can pro

33、vide a valuable source for retrospectively establishing the application specification. Furthermore, the application specification needs to be consistent with the ACCOMPANYING DOCUMENTS. Therefore it is best practice to carefully review the ACCOMPANYING DOCUMENTS. Elements of the application specific

34、ation which cannot be derived (determined) from the ACCOMPANYING DOCUMENTS need to be established using other sources. Subclause K.2.3 Review of post-production information Available post-production information is reviewed to identify known problems with the MEDICAL DEVICE with UOUP that might have

35、been caused by USABILITY problems in the USER INTERFACE. 4 62366 Amend.1 IEC:2014 Because the post-production information can be incomplete (e.g., due to under-reporting of adverse events and customer complaints) and the root cause of the problem can be difficult to identify, the MANUFACTURER should

36、 analyse the SEVERITY of the potential HARM associated with the identified problem rather than the number of event reports, customer complaints or product recalls. Add, immediately following existing Annex J, the following new annex: 62366 Amend.1 IEC:2014 5 Annex K (normative) Evaluation of a USER

37、INTERFACE OF UNKNOWN PROVENANCE (UOUP) K.1 General Annex K was created in recognition of the fact that many MANUFACTURERS will be interested in applying the tools defined in this standard to USER INTERFACES or parts of USER INTERFACES that have already been commercialized prior to the publication of

38、 this standard. Such USER INTERFACES or parts of USER INTERFACES were not developed using the PROCESSES of IEC 62366 and as a result are of unknown provenance with respect to these PROCESSES. Since this standard focuses on USABILITY ENGINEERING as part of the product development PROCESS, it was dete

39、rmined that an appropriately scaled (as described in subclause 4.3 of this standard) and alternative PROCESS should be developed to cover these USER INTERFACES or parts of USER INTERFACES of unknown provenance. The following represents such a PROCESS that relies, wherever possible, on existing docum

40、entation created during the development of a legacy USER INTERFACE or part of a USER INTERFACE. It also attempts to allow the PROCESS to be applied utilizing organizational resources as efficiently as possible. When completed, it will result in the creation of a USABILITY ENGINEERING FILE and assure

41、 that the RISK MANAGEMENT FILE identifies RISKS caused by USABILITY problems of the USER INTERFACE. The PROCESS of this annex can be applied to UOUP for a USER INTERFACE or part of a USER INTERFACE for which adequate records of the development using the USABILITY ENGINEERING PROCESS of IEC 62366:200

42、7 are not available. However, if any modifications are made to the USER INTERFACE or its parts, only the unchanged parts of the USER INTERFACE remain UOUP and the changed parts of the USER INTERFACE are subject to 5.1 to 5.9. EXAMPLE 1 For an unchanged legacy USER INTERFACE that was designed and dev

43、eloped prior to the publication of IEC 62366:2007, the USER INTERFACE is evaluated using this annex for determining conformance to this standard. EXAMPLE 2 A USER INTERFACE, without adequate records of development to IEC 62366:2007, is subsequently modified. The modified parts are evaluated using 5.

44、1 to 5.9 for determining conformance to this standard. The unmodified parts of the USER INTERFACE are evaluated using this annex for determining conformance to this standard. EXAMPLE 3 A USER INTERFACE that was designed and developed prior to the publication of IEC 62366:2007 is subsequently modifie

45、d by adding a new software feature. The USER INTERFACE of the added software feature and all parts of the USER INTERFACE that are affected by the added software feature are evaluated using 5.1 to 5.9 for determining conformance to this standard. The unmodified parts of the original USER INTERFACE ar

46、e evaluated using this annex for determining conformance to this standard. EXAMPLE 4 An existing USER INTERFACE is changed to rely on a general purpose component for which no adequate records of the development using IEC 62366:2007 exist. Changes to the existing USER INTERFACE are needed to integrat

47、e the general purpose component into the MEDICAL DEVICE. The necessary changes of the USER INTERFACE caused by integrating the general purpose component are evaluated using 5.1 to 5.9 for determining conformance to this standard. The unmodified parts of the original USER INTERFACE are evaluated usin

48、g this annex for determining conformance to this standard. K.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN PROVENANCE K.2.1 * Application specification The MANUFACTURER shall establish an application specification as required in 5.1. The MANUFACTURER shall record this application spe

49、cification in the USABILITY ENGINEERING FILE. 6 62366 Amend.1 IEC:2014 Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.2 PRIMARY OPERATING FUNCTIONS The MANUFACTURER shall identify and record the PRIMARY OPERATING FUNCTIONS of the MEDICAL DEVICE with UOUP as required by 5.4. Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.3 * Review of post-production information The MANUFACTURER