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

 

Project

Reference EN 60601-2-5
Title Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
Project Number 21936
Abstract/Scope IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition published in 2000. This edition constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty.
Status
Approval stage

Status

Current Stage code 5098
Current Stage code date 2012-05-30
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 60601-2-5:2009 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical; Ultrasonic; Physiotherapy; Safety
Note Will supersede EN 60601-2-5:2000 * 62D/766/RVC established on 2009-03-06: To be published without FDIS stage * TC advice: A proposal for a corrigendum has been issued as 62D/841/DC closing on 18th June 2010. Corrigendum delayed. See 62D/916/inf await corrigendum. Published document to be sent by CCMC to MDD consultant for assessment. Results to be passed to 62D MT 17 for meeting Sept 2011 to be drafted into corrigendum to allow listing under MDD * D141/066: VR dropped - D141/067: CLC/TC 62 & consultants to solve the negative assessment
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5098 2012-05-30    
5091 2011-01-17    
5060 2009-03-06 2009-03-25 export to doc file  EN
5020 2008-06-27 2008-11-28  
1090 2008-06-24 2008-06-27  

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 EN 60601-2-5:2000
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.