BS EN 60601-2-62:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

BS EN 60601-2-62:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Status : Current, Under review   Published : June 2015

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PDF

Format
HARDCOPY



IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to


- therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;


- therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;


- and equipment intended to be used for relieving cancer pain due to bone metastases.


This particular standard does not apply to


- Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689);


- Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36);


- Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and


- Ultrasound Equipment intended to be used for phacoemulsification.




Standard NumberBS EN 60601-2-62:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
StatusCurrent, Under review
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN 62127-2, IEC/TS 61949, EN 60601-1-2:2007, CLC/TS 61949, IEC 60601-1-2:2007, IEC 62555, IEC/TS 625564, EN 61689:2013, EN 60601-1-2:2007+corr. March:2010, IEC 62127-2, EN 62555, IEC 62359, EN 62127-1, EN 62359, IEC 61689:2013, IEC 62127-1
Informative References(Provided for Information)93/42/EEC, IEC 60529, EN 60601-2-5, ISO/IEC Guide 98-3:2008, EN 62555, EN 60529, IEC 62649, IEC 60050-802, IEC 60601-2-36, EN 61161, IEC 61161, EN 60601-2-36, IEC 62464-1, IEC 62555, IEC 61828, EN 62464-1, IEC/TR 62781, EN 61828, IEC 60601-2-5
International RelationshipsEN 60598-2-8:1997/A2:2008,EN 60601-2-62:2015,IEC 60601-2-62:2013
Draft Superseded By12/30191872 DC
DescriptorsLight hazards, Classification systems, Medical equipment, Emission, Instructions for use, Light, Safety measures, Electrical safety, Electrical medical equipment, Wavelengths, Optics, Electrical equipment, Electronic equipment and components, Clinical investigation instruments
ICS11.040.01
17.140.50
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils ultrasonores thérapeutiques de haute intensité (HITU)
Title in GermanMedizinische elektrische Geräte. Besondere Anforderungen an die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von hochintensiven therapeutischen Ultraschallsystemen (HITU-Systemen)
CommitteeCH/62/4
ISBN978 0 580 65039 0
PublisherBSI
FormatA4
DeliveryYes
Pages72
File Size1.836 MB
Price£274.00


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