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1、- - - - - - - - Medical electrical equipment Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators BS EN 60601-2-19:2009 National foreword This British Standard is the UK implementation of EN 60601-2-19:2009. It is identical to IEC 60601-2-19:2009. It
2、 supersedes BS EN 60601-2-19:1997, which will be withdrawn on 1 April 2012. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/4, Electromedical equipment. A list of organizations represented on this
3、 committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2009 ISBN 978 0 580 57521 1 ICS 11.040.10 Compliance with a British Standard cannot confer immunity
4、from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009 Amendments issued since publication Amd. No. Date Text affected BRITISH STANDARDBS EN 60601-2-19:2009 EUROPEAN STANDARD EN 60601-2-19 NORME EUROPENNE EUROPIS
5、CHE NORM May 2009 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any
6、 means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-19:2009 E ICS 11.040.10 Supersedes EN 60601-2-19:1996 + A1:1996 English version Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:200
7、9) Appareils lectromdicaux - Partie 2-19: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs pour nouveau-ns (CEI 60601-2-19:2009) Medizinische elektrische Gerte - Teil 2-19: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungs
8、merkmale von Suglingsinkubatoren (IEC 60601-2-19:2009) This European Standard was approved by CENELEC on 2009-04-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard withou
9、t any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language
10、 made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmar
11、k, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60601-2-19:2009 EN 60601-2-19:2009 - 2 - Foreword The
12、 text of document 62D/727/FDIS, future edition 2 of IEC 60601-2-19, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-19 on 2009-04-01. This European Standard
13、supersedes EN 60601-2-19:1996 + A1:1996. EN 60601-2-19:1996 was revised to structurally align with EN 60601-1:2006. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2010-01-01
14、latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-04-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD
15、 (93/42/EEC). See Annex ZZ. In this standard, 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 smaller type. Normative text of tables is also in
16、 a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.
17、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 standard are preceded by the term “Clause” followed by the clause number. References to subclauses within
18、this particular standard are by number only. In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For th
19、e purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used
20、 to describe a permissible way to achieve compliance with a requirement or test. 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 rationale related to that item in Annex AA. BS EN 60601-2-19:2009 - 3 - EN 60601-2-
21、19:2009 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-19:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the stand
22、ards indicated: IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified). IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified). IEC 61672-1 NOTE Harmonized as EN 61672-1:2003 (not modified). _ BS EN 60601-2-19:2009 EN 60601-2-19:2009 - 4 - Annex ZA (normative) Normative ref
23、erences to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document
24、(including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: I
25、EC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 Addition: IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: Gen
26、eral requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers EN 60601-1-10 2008 BS EN 60601-2-19:2009 - 5 - EN 60601-2-19:2009 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives Thi
27、s European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard prov
28、ides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. _ BS EN 60601-2-19:2009 IEC 60601-2-19 Edition 2.02009-02 INTERNATIONAL
29、STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators Appareils lectromdicaux Partie 2-19: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs pour n
30、ouveau-ns INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE W ICS 11.040.10 PRICE CODE CODE PRIX ISBN 2-8318-1030-1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-19 IEC:
31、2009 CONTENTS FOREWORD.3 INTRODUCTION.5 201.1 Scope, object and related standards .6 201.2 Normative references8 201.3 Terms and definitions8 201.4 General requirements10 201.5 General requirements for testing ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT i
32、dentification, marking and documents11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS13 201.10 Protection against unwanted and excessive radiation HAZARDS15 201.11 Protection against excessive temperatures an
33、d other HAZARDS15 201.12 Accuracy of controls and instruments and protection against hazardous outputs17 201.13 HAZARDOUS SITUATIONS and fault conditions.22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22 201.15 Construction of ME EQUIPMENT.23 201.16 ME SYSTEMS25 201.17 Electromagnetic com
34、patibility of ME EQUIPMENT and ME SYSTEMS25 202 Electromagnetic compatibility - Requirements and tests 25 210 Requirements for the development of physiologic closed-loop controllers26 Annexes .26 Annex AA (informative) Particular guidance and rationale27 Bibliography34 Index of defined terms used in
35、 this particular standard35 Figure 201.101 INFANT SKIN TEMPERATURE measurement 9 Figure 201.102 Variation of INCUBATOR TEMPERATURE.10 Figure 201.103 Layout of weight test devices.20 Table 201.101 Additional ESSENTIAL PERFORMANCE requirements11 BS EN 60601-2-19:2009 60601-2-19 IEC:2009 3 INTERNATIONA
36、L ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national
37、electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Spe
38、cifications, Technical Reports, Publicly Available Specifications (PAS) and 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. Intern
39、ational, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The for
40、mal 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 f
41、or international use and 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.
42、4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication sha
43、ll be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and 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 liab
44、ility shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (incl
45、uding legal fees) and 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
46、 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. International standard IEC 60601-2-19 has been prepared by subcommittee
47、62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 1990 and its Amendment 1 (1996). This edition constitutes a technical revision. It was revised to structurally align with th
48、e third edition (2005) of IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/727/FDIS 62D/756/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. BS EN 60601-2-19:2009 4 60601-2-19 IEC:2009 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and defin