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1、BRITISH STANDARD BS EN 60601-2-37:2008 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment ICS 11.040.55; 17.140.50 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, U
2、ncontrolled Copy, (c) BSI BS EN 60601-2-37:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2008 BSI 2008 ISBN 978 0 580 55851 1 National foreword This British Standard is the UK implementation of EN 60601-2-37:2008. It is identic
3、al to IEC 60601-2-37:2007. It supersedes BS EN 60601-2-37:2001 which The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/2, Diagnostic imaging equipment. A list of organizations represented on this co
4、mmittee 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. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda iss
5、ued since publication DateComments will be withdrawn on 1 October 2010. Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 60601-2-37 NORME EUROPENNE EUROPISCHE NORM January 2008 CENELEC European Committee for Electrotechnical Standardizat
6、ion Comit Europen de Normalisation Electrotechnique Europisches Komitee fr 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
7、 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 lectr
8、omdicaux - Partie 2-37: Exigences particulires pour la scurit de base et les performances essentielles des appareils de diagnostic et de surveillance mdicaux ultrasons (CEI 60601-2-37:2007) Medizinische elektrische Gerte - Teil 2-37: Besondere Festlegungen fr die Sicherheit einschlielich der wesentl
9、ichen Leistungsmerkmale von Ultraschallgerten fr die medizinische Diagnose und berwachung (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 E
10、uropean 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 (
11、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 Austr
12、ia, 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. Li
13、censed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI 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-C
14、ENELEC 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.
15、 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 Euro
16、pean 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
17、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 SMA
18、LL 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,
19、 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 state
20、ment 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
21、 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. BS EN 60601-2-37:2008 2 Licensed CopyChines
22、e University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI 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. _
23、Endorsement notice The text of the International Standard IEC 60601-2-37:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-2-37:2008 3 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI CONTENTS INTRODUCTION.5 201.1 Sc
24、ope, object and related standards .6 201.2 Normative references7 201.3 Terminology and definitions 7 201.4 General requirements .10 201.5 General requirements for testing ME EQUIPMENT11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT identification, marking and documents11 2
25、01.8 Protection against electrical HAZARDS from ME EQUIPMENT15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS15 201.10 Protection against unwanted and excessive radiation HAZARDS.15 201.11 Protection against excessive temperatures and other HAZARDS.16 201.12 Accuracy of c
26、ontrols and instruments and protection against hazardous outputs .20 201.13 Hazardous situations and fault conditions .21 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22 201.15 Construction of ME EQUIPMENT.22 201.16 ME SYSTEMS.22 201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME
27、 SYSTEMS22 202.6 ELECTROMAGNETIC COMPATIBILITY.22 Annex AA (informative) Guidance and rationale for particular subclauses 25 Annex BB (informative) Guidance in classification according to CISPR 11 .30 Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and MI to to be use
28、d to inform the OPERATOR31 Annex DD (informative) Example set-up to measure surface temperature of externally applied TRANSDUCER ASSEMBLIES.34 Bibliography37 Index of defined terms 40 Figure DD.1 Set-up of an example test object to measure the surface temperature of externally applied transducers 36
29、 Table 201.101 List of symbols10 Table 201.102 Distributed essential performance requirements .11 Table 201.103 Acoustic output reporting table 14 Table 201.104 Overview of the tests noted under 201.11.1.3 .19 Table CC.1 Relative importance of maintaining low exposure indices in various scanning sit
30、uations .33 Annex ZA (normative) Normative references to international publications with their corresponding European publications .41 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives 42 Table DD.1 Acoustic and thermal properties of tissues where it is intended that any par
31、t of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references Clause 2 of the general standard applies except as follows: Addition: IEC 62359, Ultrasonics Fiel
32、d characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields 201.3 Terminology and definitions For the purposes of this document, the terms and definitions given in the general standard and in IEC 62359, as well as the follow
33、ing additions apply: NOTE 1 An index of defined terms is given after the Bibliography. NOTE 2 A list of symbols used in this particular standard is found in Table 201.101. BS EN 60601-2-37:2008 7 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI 201.3.201 BON
34、E THERMAL INDEX THERMAL INDEX for applications, such as foetal (second and third trimester) or neonatal cephalic (through the fontanelle) applications, in which the ultrasound beam passes through soft tissue and there is bone close to a focal region Symbol: TIB Unit: None NOTE See IEC 62359 for meth
35、ods of determining the BONE THERMAL INDEX. 201.3.202 COMBINED-OPERATING MODE mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that combines more than one DISCRETE-OPERATING MODE 201.3.203 CRANIAL-BONE THERMAL INDEX THERMAL INDEX for applications, such as paediatric and adult cranial applications
36、, in which the ultrasound beam passes through bone near the beam entrance into the body Symbol: TIC Unit: None NOTE See IEC 62359 for methods of determining the CRANIAL-BONE THERMAL INDEX 201.3.204 DEFAULT SETTING specific state of control the ULTRASONIC DIAGNOSTIC EQUIPMENT will enter upon power-up
37、, new PATIENT select, or change from non-foetal to foetal applications 201.3.205 DISCRETE-OPERATING MODE mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT in which the purpose of the excitation of the ULTRASONIC TRANSDUCER or ULTRASONIC TRANSDUCER element group is to utilise only one diagnostic m
38、ethodology 201.3.206 FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUT means by which the ULTRASONIC DIAGNOSTIC EQUIPMENT manages the acoustic output independent of direct OPERATOR control 201.3.207 INVASIVE TRANSDUCER ASSEMBLY a transducer which, in whole or in part, penetrates inside the body, either throu
39、gh a body orifice or through the surface of the body 201.3.208 MECHANICAL INDEX the displayed parameter representing potential cavitation bioeffects Symbol: MI Unit: None NOTE See IEC 62359 for methods of determining the MECHANICAL INDEX. 201.3.209 MULTI-PURPOSE ULTRASONIC DIAGNOSTIC EQUIPMENT ULTRA
40、SONIC DIAGNOSTIC EQUIPMENT that is intended for more than one clinical application BS EN 60601-2-37:2008 8 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI 201.3.210 NON-SCANNING MODE mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a seque
41、nce of ultrasonic pulses that give rise to ultrasonic scan lines that follow the same acoustic path 201.3.211 PRUDENT USE STATEMENT affirmation of the principle advising avoidance of high exposure levels and long exposure times while acquiring only information which is clinically required 201.3.212
42、SCANNING MODE mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a sequence of ultrasonic pulses that give rise to scan lines that do not follow the same acoustic path 201.3.213 SOFT TISSUE THERMAL INDEX THERMAL INDEX related to soft tissues Symbol: TIS Unit: None NOTE 1 See IEC 6235
43、9 for methods of determination of the SOFT-TISSUE THERMAL INDEX. NOTE 2 For the purposes of this document, “soft tissue“ includes all body tissues and fluids but excludes skeletal tissues. 201.3.214 THERMAL INDEX ratio of attenuated acoustic power at a specified point to the attenuated acoustic powe
44、r required to raise the temperature at that point in a specific tissue model by 1 C. Symbol: TI Unit: None NOTE See IEC 62359 for methods of determining the THERMAL INDEX 201.3.215 TRANSDUCER ASSEMBLY the transducer housing (probe), any associated electronic circuitry, the active ultrasonic transduc
45、er module, and any liquids contained in the housing and the integral cable that connects the transducer probe to an ultrasound console 201.3.216 TRANSMIT PATTERN combination of a specific set of transducer beam-forming characteristics (determined by the transmit aperture size, apodisation shape, and
46、 relative timing/phase delay pattern across the aperture, resulting in a specific focal length and direction), and an electrical drive waveform of a specific fixed shape but variable amplitude 201.3.217 ULTRASONIC DIAGNOSTIC EQUIPMENT MEDICAL ELECTRICAL EQUIPMENT that is intended for ultrasonic medi
47、cal examination 201.3.218 ULTRASONIC TRANSDUCER device capable of converting electrical energy to mechanical energy and/or mechanical energy to electrical energy, both within the ultrasonic frequency range BS EN 60601-2-37:2008 9 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncont
48、rolled Copy, (c) BSI Table 201.101 List of symbols Symbol Term Reference Aaprt = -12dB OUTPUT BEAM AREA IEC 62359, 3.25 deq = EQUIVALENT BEAM DIAMETER IEC 62359, 3.22 fawf = ACOUSTIC WORKING FREQUENCY IEC 62359, 3.2 Ipa, = ATTENUATED PULSE-AVERAGE INTENSITY IEC 62359, 3.5 Ipi = PULSE-INTENSITY INTEG
49、RAL IEC 62359, 3.32 Ipi, = ATTENUATED PULSE-INTENSITY INTEGRAL IEC 62359, 3.6 Ispta = SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY IEC 62359, 3.38 Ita, (z) = ATTENUATED TEMPORAL-AVERAGE INTENSITY IEC 62359, 3.8 MI = MECHANICAL INDEX IEC 62359, 3.23 P = OUTPUT POWER IEC 62359, 3.27 P = ATTENUATED OUTPUT POWER IEC 62359, 3.3 Pr, = ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE IEC 62359, 3.4 Pr = PEA