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Publication details

Publication CODE Title
NBN EN 60601-2-62:2015 (2015-05) MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 4 P.
Description
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.
Class  C
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

Very important notice: 98% of the text of the NBN EN 55XXX, NBN EN 6XXXX comes from the IEC text which is NOT included. This text can be ordered here: IEC 60601-2-62:2013. For the series NBN EN 50XXX, the standards are however complete.

EN version
DE version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-04-14
NBN Approval 2015-07-24
Belgian Official Journal 2015-08-13
Registration 158298
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040.01 , 17.140.50
NBN Status New
Date of ratification (d.o.r.) 2015-04-14
Date of availability (d.a.v.) 2015-05-22
Date of announcement (d.o.a.) 2015-07-14
Date of publication (d.o.p.) 2016-01-14
Date of withdrawal former edition (d.o.w.) 2018-04-14
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-2-62:2015 2015-05-22
is identical to IEC 60601-2-62:2013/ed. 1.0 2013-07-09
Relations to belgian/foreign publications
Type Origin Code Date
Document Foreign CLC/TS 61949
Document Foreign IEC/TS 62556
Standard Belgium NBN EN 60601-1-2:2007
Standard Belgium NBN EN 61689:2013
Standard Belgium NBN EN 62127-1
Standard Belgium NBN EN 62127-2
Standard Belgium NBN EN 62359
Standard Belgium NBN EN 62555