IEC 60601-2-75-2017 Medical electrical equipment - Part 2-75 Particular requirements for the basic safety and essential performance of photodynamic therapy and .pdf

1、 IEC 60601-2-75 Edition 1.0 2017-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment Appareils lectromdicaux Partie 2-75: Exigences p

2、articulires pour la scurit de base et les performances essentielles des appareils de thrapie photodynamique et de diagnostic photodynamique IEC 60601-2-75:2017-05(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, n

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20、ONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment Appareils lectromdicaux Partie 2-75: Exigences particulires pour la scurit de base et les per

21、formances essentielles des appareils de thrapie photodynamique et de diagnostic photodynamique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01 ISBN 978-2-8322-4420-3 Registered trademark of the International Electrotechnical Commission Marque dpose

22、de la Commission Electrotechnique Internationale 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. 2 IEC 60601-2-75:2017 IEC 2017 CONTENTS FOREWORD . 3 201.1 Scope, ob

23、ject and related standards . 5 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements . 11 201.5 General requirements for testing ME EQUIPMENT 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8

24、Protection against electrical HAZARDS from ME EQUIPMENT . 14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 15 201.12 Accuracy

25、 of controls and instruments and protection against hazardous OUTPUTS 15 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19 201.15 Construction of ME EQUIPMENT . 20 201.16 ME SYSTEMS 20 201.17 Electromagnetic compatibilit

26、y of ME EQUIPMENT and ME SYSTEMS . 20 Annexes . 20 Annex AA (informative) General guidance and rationale 21 Annex BB (informative) Specific HAZARDOUS SITUATIONS and HARMS and RISK ASSESSMENT guidance . 25 Bibliography 27 Index of defined terms used in this particular standard 28 Table AA.1 Character

27、istics relevant to parameters . 22 Table BB.1 Specific HAZARDOUS SITUATIONS and HARMS 25 IEC 60601-2-75:2017 IEC 2017 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy a

28、nd photodynamic diagnosis equipment 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 questio

29、ns concerning standardization in the electrical and electronic fields. To this 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 “IEC Publication(s)

30、). 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 and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collab

31、orates closely with the International Organization for Standardization (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

32、 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 and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure

33、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 th

34、e maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification b

35、odies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services 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

36、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 (including legal fees) a

37、nd 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.

38、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 60601-2-75 has been prepared by subcommittee 62D: Electromedical

39、 equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1477/FDIS 62D/1490/RVD Full information on the voting for the approval of this standard can be found in the report

40、on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 4 IEC 60601-2-75:2017 IEC 2017 In this standard, the following print types are used: requirements and definitions: roman type; test specifications: italic type; informative ma

41、terial appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in 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,

42、 the term “clause” means one of the seventeen numbered divisions within the table 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 t

43、o clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within 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

44、 is true. The verbal forms used in this standard conform to usage described in Clause 7 of the ISO/IEC Directives, Part 2. For the 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

45、that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used 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 ta

46、ble title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will

47、 remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IEC 60601-2-75:2017 IEC 2017 5 MEDICAL ELEC

48、TRICAL EQUIPMENT Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment 201.1 Scope, object and related standards Clause 1 of the general standard 1applies, except as follows: 201.1.1 Scope Replacement: This part

49、 of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZAR