1、 IEC 80601-2-59 Edition 2.0 2017-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening Appareils lectromdicaux Partie 2-59: Exigen
2、ces particulires pour la scurit de base et les performances essentielles des imageurs thermiques pour le dpistage des humains fbriles IEC 80601-2-59:2017-09(en-fr) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherwise spec
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20、NTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening Appareils lectromdicaux Partie 2-59: Exigences particulires pour la scurit de ba
21、se et les performances essentielles des imageurs thermiques pour le dpistage des humains fbriles INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.55 ISBN 978-2-8322-4815-7 Warning! Make sure that you obtained this publication from an authorized distribu
22、tor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 80601-2-59:2017 IEC 2017 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 9 201.3 Terms and definitions 10 201.4 Ge
23、neral requirements . 12 201.5 General requirements for testing ME EQUIPMENT 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT identification, marking and documents . 13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14 201.9 Protection against mechanical H
24、AZARDS of ME EQUIPMENT and ME SYSTEMS 14 201.10 Protection against unwanted and excessive radiation HAZARDS . 15 201.11 Protection against excessive temperatures and other HAZARDS . 15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 15 201.13 HAZARDOUS SITUATIO
25、NS and fault conditions for ME EQUIPMENT . 16 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16 201.15 Construction of ME EQUIPMENT . 16 201.16 ME SYSTEMS 16 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16 201.101 LABORATORY ACCURACY of a SCREENING THERMOGRAPH . 17
26、201.102 SCREENING THERMOGRAPH ALARM CONDITIONS . 20 202 Electromagnetic disturbances Requirements and tests . 21 206 USABILITY 21 Annexes . 23 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 23 Annex AA (informative) Particular guidance and rationale
27、 25 Annex BB (normative) CALIBRATION SOURCE . 32 Annex CC (informative) Reference to the essential principles 33 Bibliography 36 Index of defined terms used in this document . 40 Figure AA.1 Illustration of TARGET in the visible spectrum . 27 Figure AA.2 Illustration of TARGET in the infrared spectr
28、um 27 Figure AA.3 Relative drift of 4 DETECTORS as a function of time 30 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 13 Table 201.C.101 Marking on the outside of a SCREENING THERMOGRAPH or its parts 23 Table 201.C.102 ACCOMPANYING DOCUMENTS, general of a SCREENING THERMOGRAPH 23 Tab
29、le 201.C.103 ACCOMPANYING DOCUMENTS, instructions for use of a SCREENING THERMOGRAPH . 24 IEC 80601-2-59:2017 IEC 2017 3 Table 201.C.104 ACCOMPANYING DOCUMENTS, technical description of a SCREENING THERMOGRAPH . 24 Table AA.1 Example of relevant uncertainty terms for a SCREENING THERMOGRAPH . 28 Tab
30、le CC.1 Correspondence between this document and the essential principles . 33 4 IEC 80601-2-59:2017 IEC 2017 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human
31、 febrile temperature screening FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions co
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41、tention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 80601-2-59 has been prepared by a Joint Working Group of IEC subcommi
42、ttee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and of ISO subcommittee SC3: Lung ventilators and related equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment. This second edition cancels and replaces the first
43、edition published in 2008. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious dise
44、ases in general. IEC 80601-2-59:2017 IEC 2017 5 The text of this document is based on the following documents: FDIS Report on voting 62D/1501/FDIS 62D/1515/RVD Full information on the voting for the approval of this document can be found in the report on voting indicated in the above table. This pub
45、lication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this document, the following print types are used: requirements and definitions: roman type; test specifications: italic type; informative material appearing outside of tables, such as notes, examples and references: in
46、smaller type. Normative text of tables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR DOCUMENT OR AS NOTED: SMALL CAPITALS. In referring to the structure of this document, the term: “clause” means one of the seventeen numbered divisions within the ta
47、ble of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this document are preceded by the term “Clause” followed by t
48、he clause number. References to subclauses within this particular document are by number only. In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this document conform to usage described in
49、 Clause 7 of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this document ; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document ; “may” is used to describe a permissible way to achieve compliance with a requir
