Hivatkozási szám

MSZ EN IEC 63045:2021

Dokumentumazonosító

176296

Cím

Ultrahang. Nem fókuszáló, rövid nyomásimpulzusos források, beleértve a ballisztikus nyomásimpulzusos forrásokat. A terek jellemzői (IEC 63045:2020)

Angol cím

Ultrasonics. Non-focusing short pressure pulse sources including ballistic pressure pulse sources. Characteristics of fields (IEC 63045:2020)

Alkalmazási terület

This document 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 mikroszekundum. 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. NOTE 1 The parameters defined in this document do not – at the time of publication – allow quantitative statements to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the limits for these effects. NOTE 2 Figure B.1 to Figure B.10 and Figure 2 to Figure 4 are useful to understand the geometry of the field applied in this document. 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).

ICS

17.140.50 Elektroakusztika

A szabvány nyelve

angol

Az érvényesség kezdete

2021-01-01

Forrás

idt IEC 63045:2020; idt EN IEC 63045:2020

Előd

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

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