IEC 61846-ed.2.0

Podrobné informace

Označení: IEC 61846-ed.2.0

Datum vydání: 30.01.2025

Stran: 80

Země: Mezinárodní technická norma

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Anotace

IEC 61846:2025 is applicable to: – therapy equipment using extracorporeally induced focused pressure pulse waves; – therapy equipment producing focused mechanical energy excluding thermal energy. This document does not apply to percutaneous and laser lithotripsy equipment. This document does not apply to: – histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the pressure pulse; – non-focused pressure pulse equipment. This document specifies: – measurable parameters which could be used in the declaration of the acoustic output of extracorporeal focused pressure pulse equipment; – methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment. While this document has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal focused pressure pulse equipment, this document can be used as a guideline. IEC 61846:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) Change of title: "pressure pulse lithotripters" in the previous edition is changed to "therapeutic focused short pressure pulse sources" in order to take into account the development in the relevant technical and biomedical applications of such sources, which were originally used only for (kidney) lithotripsy, while recent applications include a wide range for the treatment of, for example, stone diseases, orthopaedic pain, tissue, cardiac and brain diseases. The term "focused" was added to differentiate IEC 61846 from IEC 63045. The term "short" was added to align the nomenclature to IEC 63045 and to differentiate IEC 61846 from standards in the HIFU and HITU fields. b) Clause 1 and elsewhere in the document: The term "lithotripsy" is changed to "therapy" in order to account for the wide range of applications beyond stone diseases. c) Clause 3: The "-6 dB" parameter definitions are replaced by "-n dB" to avoid misconceptions in the significance and use of these parameters and to account for newer findings in literature. Additional "n MPa" parameters are introduced for the same reasons. The definitions of "derived" parameters are aligned to those in recently published standards, for example IEC 62127-1. New definitions were added which describe parameters appearing in newer relevant literature, for example "momentum", "average positive acoustic pressure", "cavitation induction index", "pulse to pulse variability", "total pressure pulse energy dose". d) Clause 6: The terms "focus hydrophone" and "field hydrophone" were removed to account for newer technical developments. New terms distinguish between "hydrophones for pressure pulse measurements" and "hydrophones for quality assurance". e) Annexes: Descriptions, tables and figures were edited to account for newer literature and standards as well as technical developments. LIEC 61846:2025 sapplique: – aux appareils de traitement qui utilisent des ondes dimpulsions de pression focalisees generees de maniere extracorporelle; – aux appareils de traitement qui produisent une energie mecanique focalisee, a lexclusion de lenergie thermique. Le present document ne sapplique pas aux appareils de lithotritie percutanee et laser. Le present document ne sapplique pas: – a lhistotripsie ou autres salves dultrasons therapeutiques dune duree plus longue que celle de limpulsion de pression; – aux appareils a impulsions de pression non focalisees. Le present document specifie: – les parametres mesurables qui peuvent etre utilises dans la declaration des emissions acoustiques des appareils a impulsions de pression focalisees generees de maniere extracorporelle; – les methodes de mesure et de caracterisation du champ de pression genere par les appareils a impulsions de pression focalisees. Le present document a ete elabore pour des appareils destines a etre utilises en lithotritie. Il peut etre utilise comme ligne directrice pour dautres applications medicales concernant des appareils therapeutiques a impulsions de pression focalisees generees de maniere extracorporelle, tant quaucune autre norme specifique nest disponible. LIEC 61846:2025 annule et remplace la premiere edition parue en 1998. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) Modification du titre: Le terme "lithotriteurs a impulsion de pression" utilise dans ledition precedente a ete modifie en "sources dimpulsions de pression courtes focalisees therapeutiques" afin de prendre en compte le developpement des applications techniques et biomedicales pertinentes de ces types de sources, qui netaient a lorigine utilisees que pour la lithotritie (renale), tandis que les applications recentes couvrent un large eventail de traitements, par exemple, des maladies des calculs, des douleurs orthopediques, ainsi que des maladies tissulaires, cardiaques et cerebrales. Ladjectif "focalisees" a ete ajoute pour distinguer lIEC 61846 de lIEC 63045. Ladjectif "courtes" a ete ajoute afin daligner la nomenclature sur lIEC 63045 et de distinguer lIEC 61846 des normes relatives aux champs a ultrasons focalises de haute intensite (HIFU, High Intensity Focalised Ultrasound) et aux champs a ultrasons therapeutiques de haute intensite (HITU, High Intensity Therapeutic Ultrasound). b) Article 1 et ailleurs dans le document: Le terme "lithotritie" a ete modifie en "therapie" afin de tenir compte du large eventail dapplications qui depassent le cadre des maladies des calculs. c) Article 3: Les definitions des parametres "-6 dB" ont ete remplacees par "-n dB" afin deviter des malentendus concernant la signification et lutilisation d