EN 60601-2-37:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons (CEI 60601-2-37:2007)Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung (IEC 60601-2-37:2007)Ta slovenski standard je istoveten z:EN 60601-2-37:2008SIST EN 60601-2-37:2008en,fr17.140.5011.040.55ICS:SIST EN 60601-2-37:2002/A1:2005SIST EN 60601-2-37:20021DGRPHãþDSLOVENSKI
STANDARDSIST EN 60601-2-37:200801-april-2008

EUROPEAN STANDARD EN 60601-2-37 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2008
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-37:2008 E
ICS 11.040.55; 17.140.50 Supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005
English version
Medical electrical equipment -
Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical diagnostic
and monitoring equipment (IEC 60601-2-37:2007)
Appareils électromédicaux -
Partie 2-37: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils de diagnostic
et de surveillance médicaux à ultrasons (CEI 60601-2-37:2007)
Medizinische elektrische Geräte -
Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung (IEC 60601-2-37:2007)
This European Standard was approved by CENELEC on 2007-10-01. 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 without 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 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, Denmark, 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.

- 2 - Foreword The text of document 62B/624/CDV, future edition 2 of IEC 60601-2-37, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by CENELEC as EN 60601-2-37 on 2007-10-01. This European Standard supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005. EN 60601-2-37:2008 combines EN 60601-2-37:2001 + A1:2005 + A2:2005 into a form compatible with the parent 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) 2008-08-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow) 2010-10-01 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 93/42/EEC. See Annex ZZ. In this standard, the following print types are used:
requirements and definitions: in roman type;
test specifications: in italic type;
informative material 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: IN 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.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 this 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 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 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.

- 3 - EN 60601-2-37:2008 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. Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-2-37:2007 was approved by CENELEC as a European Standard without any modification. __________

- 4 -
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
Addition to Annex ZA of EN 60601-1:2006:
Publication
Year Title EN/HD Year IEC 62359 –1) Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields EN 62359 20052)
__________
1) Undated reference. 2) Valid edition at date of issue.

- 5 - EN 60601-2-37:2008 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This 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 provides 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. __________

IEC 60601-2-37Edition 2.0 2007-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Appareils électromédicaux – Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XICS 11.040.55; 17.140.50 PRICE CODECODE PRIXISBN 2-8318-9266-X

– 2 – 60601-2-37 © IEC:2007 CONTENTS FOREWORD.4 INTRODUCTION.6
201.1 Scope, object and related standards.7 201.2 Normative references.8 201.3 Terminology and definitions.8 201.4 General requirements.11 201.5 General requirements for testing ME EQUIPMENT.12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.12 201.7 ME EQUIPMENT identification, marking and documents.12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.16 201.10 Protection against unwanted and excessive radiation HAZARDS.16 201.11 Protection against excessive temperatures and other HAZARDS.17 201.12 Accuracy of controls and instruments and protection against hazardous outputs.21 201.13 Hazardous situations and fault conditions.22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).23 201.15 Construction of ME EQUIPMENT.23 201.16 ME SYSTEMS.23 201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.23 202.6 ELECTROMAGNETIC COMPATIBILITY.23
Annex AA (informative)
Guidance and rationale for particular subclauses.26 Annex BB (informative)
Guidance in classification according to CISPR 11.31 Annex CC (informative)
Guidance to the MANUFACTURER on the interpretation of TI and MI
to be used to inform the OPERATOR.32 Annex DD (informative)
Example set-up to measure surface temperature
of externally applied TRANSDUCER ASSEMBLIES.35
Bibliography.38
Index of defined terms.41
Figure DD.1 – Set-up of an example test object to measure the surface temperature
of externally applied transducers.37
Table 201.101 – List of symbols.11 Table 201.102 – Distributed essential performance requirements.12 Table 201.103 –Acoustic output reporting table.15 Table 201.104 – Overview of the tests noted under 201.11.1.3.20 Table CC.1 – Relative importance of maintaining low exposure indices in various scanning situations.34

60601-2-37 © IEC:2007 – 3 –
Table DD.1 – Acoustic and thermal properties of tissues & materials.35 Table DD.2 – Weight % pure components.36

– 4 – 60601-2-37 © IEC:2007 INTERNATIONAL ELECTROTECHNICAL COMMISSION ______________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring 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 questions 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)”). 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 collaborates 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 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 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 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 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 liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees
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