International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference FprEN 60601-2-62:2013
Title Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Project Number 23954
Abstract/Scope 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.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2013-09-30
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-62:2013 (EQV)
ICS 11.040.01 - Medical equipment in general
17.140.50 - Electroacoustics
Keywords Medical; High intensity; Therapeutic; Ultrasound; HITU
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2013-09-30    
5060 2013-05-27 2013-06-17 export to doc file  EN
5020 2013-03-22 2013-05-24  
3090 2013-03-19 2013-03-22  
5060 2012-05-29 2012-06-19 export to doc file  EN
5020 2011-12-23 2012-05-25  
1090 2011-12-20 2011-12-23  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) dor + 3 months
date of Publication (DOP) (4) dor + 9 months
date of Withdrawal (DOW) (5) dor + 36 months

Relations

Supersedes  
Superseded by  
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.