1、 IEC 82304-1 Edition 1.0 2016-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Health software Part 1: General requirements for product safety Logiciels de sant Partie 1: Exigences gnrales pour la scurit des produits IEC 82304-1:2016-10(en-fr) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copy
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19、 des questions contactez-nous: csciec.ch. IEC 82304-1 Edition 1.0 2016-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Health software Part 1: General requirements for product safety Logiciels de sant Partie 1: Exigences gnrales pour la scurit des produits INTERNATIONAL ELECTROTECHNICAL COMMISSION CO
20、MMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 35.240.80 ISBN 978-2-8322-3733-5 Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 82304-1:2016 IEC 20
21、16 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope 6 1.1 Purpose 6 1.2 Field of application 6 1.3 Compliance . 6 2 Normative references 6 3 Terms and definitions 7 4 * HEALTH SOFTWARE PRODUCT requirements 10 4.1 General requirements and initial RISK ASSESSMENT 10 4.2 HEALTH SOFTWARE PRODUCT use requi
22、rements . 11 4.3 VERIFICATION of HEALTH SOFTWARE PRODUCT use requirements 11 4.4 Updating HEALTH SOFTWARE PRODUCT use requirements . 12 4.5 System requirements 12 4.6 VERIFICATION of system requirements 12 4.7 Updating HEALTH SOFTWARE PRODUCT system requirements . 12 5 * HEALTH SOFTWARE Software lif
23、e cycle processes 13 6 * HEALTH SOFTWARE PRODUCT VALIDATION . 13 6.1 VALIDATION plan 13 6.2 Performing VALIDATION 13 6.3 VALIDATION report 14 7 HEALTH SOFTWARE PRODUCT identification and ACCOMPANYING DOCUMENTS 14 7.1 * Identification . 14 7.2 ACCOMPANYING DOCUMENTS . 14 7.2.1 General . 14 7.2.2 Inst
24、ructions for use 15 7.2.3 Technical description . 17 8 Post-market activities for the HEALTH SOFTWARE PRODUCT . 18 8.1 General . 18 8.2 SOFTWARE MAINTENANCE 18 8.3 Re-VALIDATION . 19 8.4 Post-market communication on the HEALTH SOFTWARE PRODUCT . 19 8.5 Decommissioning and disposal of the HEALTH SOFT
25、WARE PRODUCT . 19 Annex A (informative) Rationale . 20 A.1 General . 20 A.2 Requirements for HEALTH SOFTWARE PRODUCTS 21 A.3 Rationale for particular clauses and subclauses 22 Bibliography 26 Figure A.1 HEALTH SOFTWARE application domains and scope of related standards 22 Figure A.2 IEC 82304-1: HEA
26、LTH SOFTWARE PRODUCT processes 23 Table A.1 Examples of software (SW) in or not in the scope of this document 21 IEC 82304-1:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ HEALTH SOFTWARE Part 1: General requirements for product safety FOREWORD 1) The International Electrotechnical Comm
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37、ion may be the subject of patent 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: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electric
38、al equipment in medical practice, and ISO technical committee 215: Health informatics. It is published as a double logo standard. The text of this standard is based on the following documents of IEC: FDIS Report on voting 62A/1140/FDIS 62A/1151/RVD Full information on the voting for the approval of
39、this part of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 21 P members out of 22 having cast a vote. 4 IEC 82304-1:2016 IEC 2016 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Terms de
40、fined in Clause 3 of this standard are printed in SMALL CAPITALS. For the purposes of this standard: “shall” means that compliance with a requirement is mandatory for compliance with this standard; “should” means that compliance with a requirement is recommended but is not mandatory for compliance w
41、ith this standard; “may” is used to describe a permissible way to achieve compliance with a requirement; and “establish” means to define, document, and implement. An asterisk (* ) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or
42、rationale related to that item in Annex A. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be
43、reconfirmed, withdrawn, replaced by a revised edition, or amended. 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 usi
44、ng a colour printer. NOTE The attention of National Committees is drawn to the fact that 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 accordance with the new requirements
45、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. IEC 82304-1:2016 IEC 2016 5 INTRODUCTION HEALTH SOFTWA
46、RE PRODUCTS, within the context of this document, are software-only products. These products are intended to be used with computing equipment not explicitly developed for running the software. HEALTH SOFTWARE PRODUCTS may require specified platforms. HEALTH SOFTWARE PRODUCTS are intended by their MA
47、NUFACTURER for managing, maintaining or improving health of individual persons, or the delivery of care. Some HEALTH SOFTWARE can contribute to a HAZARDOUS SITUATION. Accordingly, Clause 5 requires a RISK MANAGEMENT process for all HEALTH SOFTWARE. For HEALTH SOFTWARE that can contribute to a HAZARD
48、OUS SITUATION, RISK CONTROL is needed to prevent HARM or reduce the likelihood of HARM occurring. Testing of the finished product is not, by itself, adequate to address the SAFETY of HEALTH SOFTWARE. Therefore, requirements for the processes by which the HEALTH SOFTWARE is developed are necessary. T
49、his document relies heavily on IEC 62304:2006 and IEC 62304:2006/AMD1:2015 for the software development process which can be applied to HEALTH SOFTWARE PRODUCTS. Whether a HEALTH SOFTWARE PRODUCT has to meet regulatory requirements is a matter of national legislation. This document makes no attempt to determine whether a HEALTH SOFTWARE PRODUCT is or should be regulated. This document aims to provide requirements for the SAFETY an
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