ISBN 978-0-626-33793-3 Edition 1.1 IEC 60601-2-19:2016 Edition 2.1 SOUTH AFRICAN NATIONAL STANDARD Medical electrical equipment Part 2-19: Particular requirements for the basic safety essential performance of infant incubators This national stard is the identical implementation of IEC 60601-2-19:2016, is adopted with the permission of the International Electrotechnical Commission. WARNING This document references other documents normatively. Published by SABS Stards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001 Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS
Edition 1.1 IEC 60601-2-19:2016 Edition 2.1 Table of changes Change No. Date Scope IEC corr.1 2012 Changed to replace the table on additional essential performance requirements of infant incubators (table 201.101), to correct cross-references to the numbers of two subclauses (on sound level within the compartment on warm-up time). IEC amdt 1 2016 Amended to update the scope, normative references, terms definitions, warnings safety notices on control devices, to clarify the indication of relative humidity, to update requirements a test for electromagnetic compatibility, to update, in the annexes, information on monitoring temperature temperature alarms of patients, to update the bibliography the index. National foreword This South African stard was approved by National Committee SABS/TC 162, Performance safety of electrical equipment in medical practice, in accordance with procedures of the SABS Stards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was approved for publication in December 2016. This document supersedes SANS 60601-2-19:2009 (edition 1 as modified by IEC corr.1:2012). Compliance with this document cannot confer immunity from legal obligations. SABS
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION VERSION CONSOLIDÉE colour inside Medical electrical equipment Part 2-19: Particular requirements for the basic safety essential performance of infant incubators Appareils électromédicaux Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.10 ISBN 978-2-8322-3375-7 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 agréé. Registered trademark of the International Electrotechnical Commission Marque déposée de la Commission Electrotechnique Internationale
2 IEC 60601-2-19:2009+AMD1:2016 CSV IEC 2016 CONTENTS FOREWORD... 3 INTRODUCTION... 6 201.1 Scope, object related stards... 7 201.2 Normative references... 9 201.3 Terms definitions... 9 201.4 General requirements... 11 201.5 General requirements for testing 201.6 Classification of 201.7 ME 201.8 Protection against electrical 201.9 Protection against EQUIPMENT... 12 ME SYSTEMS... 12 identification, marking documents... 12 HAZARDS from MECHANICAL HAZARDS of... 14 ME SYSTEMS... 14 201.10 Protection against unwanted excessive radiation HAZARDS... 16 201.11 Protection against excessive temperatures other HAZARDS... 16 201.12 Accuracy of controls instruments protection against hazardous outputs... 18 201.13 H AZARDOUS SITUATIONS fault conditions... 23 201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) 201.15 Construction of... 24 201.16 M E SYSTEMS... 26 201.17 Electromagnetic compatibility of 202... 23 ME SYSTEMS... 26 Electromagnetic compatibility - Requirements tests... 26 Annexes... 27 Annex AA (informative) Particular guidance rationale... 28 Bibliography... 37 Index of defined terms used in this particular stard... 38 Figure 201.101 Positioning of air temperature sensors... 10 Figure 201.102 Variation of INCUBATOR TEMPERATURE... 11 Figure 201.103 Layout of weight test devices... 21 Figure AA.1 Illustration of the main requirements of this stard... 29 Table 201.101 Additional ESSENTIAL PERFORMANCE requirements... 12
IEC 60601-2-19:2009+AMD1:2016 CSV IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT Part 2-19: Particular requirements for the basic safety essential performance of infant incubators FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for stardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning stardization in the electrical electronic fields. To this end in addition to other activities, IEC publishes International Stards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) Guides (hereafter referred to as IEC Publication(s) ). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental nongovernmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Stardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national regional publications. Any divergence between any IEC Publication the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 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 members of its technical committees IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable 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 of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. DISCLAIMER This Consolidated version is not an official IEC Stard has been prepared for user convenience. Only the current versions of the stard its amendment(s) are to be considered the official documents. This Consolidated version of IEC 60601-2-19 bears the edition number 2.1. It consists of the second edition (2009-02) [documents 62D/727/FDIS 62D/756/RVD], its corrigendum 1 (2012-02) its amendment 1 (2016-04) [documents 62D/1324/FDIS 62D/1345/RVD]. The technical content is identical to the base edition its amendment. This Final version does not show where the technical content is modified by amendment 1. A separate Redline version with all changes highlighted is available in this publication.