IEC_82304-1-2016.pdf

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email.publication ou si vous avez des questions contactez-nous:csciec.ch.-2-1EC82304-1:2016IEC2016CONTENTSFOREWORD.3INTRODUCTION.51SCOp.1.1Purp0se61.2Field of application.61.3Compliance.62 Normative references63 Torms and definition4*HEALTH SOFTWARE PRODUCT requirements.104.1 General requirements and initial RISK ASSESSMENT.104.2HEALTH SOFTWARE PRODUCT use requirements.114.3VERIFICATION of HEALTH SOFTWARE PRODUCT use requirements.114.4Updating HEALTH SOFTWARE PRODUCT use requirements.124.5System requirements.124.6VERIFICATION of system requirements124.7Updating HEALTH SOFTWARE PRODUCT system requirements.125*HEALTH SOFTWARE-Software life cycle processes.136*HEALTH SOFTWARE PRODUCT VALIDATION.136.1VALIDATION plan.136.2Performing VALIDATION.136.3VALIDATION report.147 HEALTH SOFTWARE PRODUCT identification and ACCOMPANYING DOCUMENTS.147.1ldentification.47.2ACCOMPANYING DOCUMENTS.147.2.17.2.2Instructions for use.157.2.3Technical description.78 Post-market activities for the HEALTH SOFTWARE PRODUCT.188.1General.88.2SOFTWARE MAINTENANCE.188.3Re-VALIDATION.198.4Post-market communication on the HEALTH SOFTWARE PRODUCT.198.5Decommissioning and disposal of the HEALTH SOFTWARE PRODUCT.19Annex A(informative)Rationale.2A.1.28A.2Requirements for HEALTH SOFTWARE PRODUCTS.21A.3Rationale for particular clauses and subclauses.22Bibliography.26Figure A.1-HEALTH SOFTWARE application domains and scope of related standards.22Figure A.2-IEC 82304-1:HEALTH SOFTWARE PRODUCT processes.23Table A.1-Examples of software(SW)in or not in the scope of this document.211EC82304-1:20161EC2016-3INTERNATIONAL ELECTROTECHNICAL COMMISSIONHEALTH SOFTWARE-Part 1:General requirements for product safetyFOREWORD1)The International Electrotechnical Commission(IEC)is a worldwide organization for standardization comprisingall national electrotechnical committees(IEC National Committees).The object of IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields.Tothis 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 IECPublication(s).Their preparation is entrusted to technical committees;any IEC National Committee interestedin 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 closelywith the International Organization for Standardization(ISO)in accordance with conditions determined byagreement between the two organizations.2)The formal decisions or agreements of IEC on technical matters express,as nearly as possible,an internationalconsensus of opinion on the relevant subjects since each technical committee has representation from allinterested IEC National Committees.3)IEC Publications have the form of recommendations for international use and are accepted by IEC NationalCommittees in that sense.While all reasonable efforts are made to ensure that the technical content of IECPublications is accurate,IEC cannot be held responsible for the way in which they are used or for anymisinterpretation by any end user.4)In order to promote international uniformity,IEC National Committees undertake to apply IEC Publicationstransparently to the maximum extent possible in their national and regional publications.Any divergencebetween any IEC Publication and the corresponding national or regional publication shall be clearly indicated inthe latter.5)IEC itself does not provide any attestation of conformity.Independent certification bodies provide conformityassessment services and,in some areas,access to IEC marks of conformity.IEC is not responsible for anyservices 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 experts andmembers of its technical committees and IEC National Committees for any personal injury,property damage orother damage of any nature whatsoever,whether direct or indirect,or for costs(including legal fees)andexpenses arising out of the publication,use of,or reliance upon,this IEC Publication or any other IECPublications.8)Attention is drawn to the Normative references cited in this publication.Use of the referenced publications isindispensable for the correct application of this publication.9)Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject ofpatent rights.IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 82304-1 has been prepared by subcommittee 62A:Commonaspects of electrical equipment used in medical practice,of IEC technical committee 62:Electrical equipment in medical practice,and ISO technical committee 215:Healthinformatics.It is published as a double logo standardThe text of this standard is based on the following documents of IEC:FDISReport on voting62A/1140/FDIS62A/1151/RVDFull information on the voting for the approval of this part of this standard can be found in thereport on voting indicated in the above table.In ISO,the standard has been approved by 21 Pmembers out of 22 having cast a vote.FIEFFHFFe