EN IEC 63045:2020

Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields

IEC 63045:2020 is applicable to – therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses; – therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy, where the pressure pulses are released as single events of duration up to 25 µs. This document does not apply to – therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment; – therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment. This document specifies – measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field, – methods of measurement and characterization of non-focused or weakly focused pressure pulse fields. This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).

Ultraschall - Quellen für nicht fokussierte kurze Druckimpulse einschließlich pneumatischen und ballistischen Druckpulsquellen - Feldcharakterisierung

Ultrasons - Sources d'impulsions de pression courtes sans focalisation, y compris les sources d'impulsions de pression balistiques - Caractéristiques des champs

L'IEC 63045:2020 s’applique – à l’appareil de traitement utilisant des impulsions de pression faiblement ou non focalisées générées de manière extracorporelle; – à l’appareil de traitement produisant une énergie mécanique faiblement ou non focalisée générée de manière extracorporelle; lorsque les impulsions de pression sont délivrées de manière unitaire pendant une durée allant jusqu’à 25 µs. Le présent document ne s’applique pas – à l’appareil de traitement utilisant des sources d’impulsions de pression focalisées tel que l’appareil de lithotritie extracorporelle; – à l’appareil de traitement utilisant d’autres formes d'ondes acoustiques comme l’appareil de physiothérapie, l’appareil à ultrasons de basse intensité et l’appareil à ultrasons focalisés de haute intensité (HIFU, high intensity focussed ultrasounds) ou l’appareil à ultrasons thérapeutiques de haute intensité (HITU, high intensity therapeutic ultrasound). Le présent document spécifie – les paramètres mesurables qui sont utilisés dans la déclaration de la production acoustique des appareils extracorporels qui produisent un champ d'impulsions de pression faiblement ou non focalisées , – les méthodes de mesure et de caractérisation du champ de pression généré par les champs d’impulsions de pression faiblement ou non focalisées. Le présent document a été élaboré pour les appareils dont l’utilisation prévue est la thérapie par impulsions de pression, par exemple le traitement des douleurs orthopédiques telles que les douleurs de l’épaule, les douleurs d’épicondylite, les douleurs de l’épine calcanéenne, le traitement musculaire des points de fibromyalgie, les douleurs lombaires, etc. Il n’est pas destiné à être utilisé pour l’appareil de lithotritie extracorporelle (comme cela est décrit dans l’IEC 61846), l’appareil de physiothérapie utilisant d’autres formes d’ondes (comme cela est décrit dans l’IEC 61689) et l’appareil HIFU/HITU (voir l’IEC 60601 2-62 et l’IEC TR 62649).

Ultrazvok - Viri nefokusiranih kratkih impulzov tlaka, vključno z viri balističnih impulzov tlaka - Karakteristike polj (IEC 63045:2020)

General Information

• Status: Published
• Publication Date: 23-Jul-2020
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 87 - CLC/SR 87
• Drafting Committee: IEC/TC 87 - IEC_TC_87
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Jul-2020
• Completion Date: 24-Jul-2020
• Ref Project: SIST EN IEC 63045:2020 - Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields (IEC 63045:2020)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 63045:2020
01-november-2020
Ultrazvok - Viri nefokusiranih kratkih impulzov tlaka, vključno z viri balističnih
impulzov tlaka - Karakteristike polj (IEC 63045:2020)
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure
pulse sources - Characteristics of fields (IEC 63045:2020)
Ultraschall - Quellen für nicht fokussierte kurze Druckimpulse einschließlich
pneumatischen und ballistischen Druckpulsquellen - Feldcharakterisierung (IEC
63045:2020)
Ultrasons - Sources d'impulsions de pression courtes sans focalisation, y compris les
sources d'impulsions de pression balistiques - Caractéristiques des champs (IEC
63045:2020)
Ta slovenski standard je istoveten z: EN IEC 63045:2020
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 63045:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 63045:2020

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SIST EN IEC 63045:2020


EUROPEAN STANDARD EN IEC 63045

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2020
ICS 17.140.50

English Version
Ultrasonics - Non-focusing short pressure pulse sources
including ballistic pressure pulse sources - Characteristics of
fields
(IEC 63045:2020)
Ultrasons - Sources d'impulsions de pression courtes sans Ultraschall - Quellen für nicht fokussierte kurze
focalisation, y compris les sources d'impulsions de pression Druckimpulse einschließlich pneumatischen und
balistiques - Caractéristiques des champs ballistischen Druckpulsquellen - Feldcharakterisierung
(IEC 63045:2020) (IEC 63045:2020)
This European Standard was approved by CENELEC on 2020-06-29. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 63045:2020 E

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SIST EN IEC 63045:2020
EN IEC 63045:2020 (E)
European foreword
The text of document 87/741/FDIS, future edition 1 of IEC 63045, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 63045:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-03-29
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-06-29
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 63045:2020 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 standards
indicated:
IEC 60601-2-62 NOTE Harmonized as EN 60601-2-62
IEC 60601-2-36 NOTE Harmonized as EN 60601-2-36
IEC 61689 NOTE Harmonized as EN 61689
IEC 61828:2001 NOTE Harmonized as EN 61828:2001 (not modified)
IEC 63009 NOTE Harmonized as EN IEC 63009


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SIST EN IEC 63045:2020
EN IEC 63045:2020 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document.
...