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

 

Project

Reference EN 60601-2-37:2008/A11:2011
Title Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Project Number 23808
Abstract/Scope Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2011-10-14
Current Stage code deadline 2012-10-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body  
Reference Document  
ICS 11.040.55 - Diagnostic equipment
17.140.50 - Electroacoustics
Keywords Medical equipment; Ultrasonic; Diagnostic; Monitoring; Safety
Note D139/C149: BT approved the modified Annex ZZ for EN 60601-2-37:2008
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2011-10-14 2012-10-01 export to doc file  EN  FR  DE
5099 2011-10-01 2012-02-01  
1099 2011-04-13 2011-10-10  

Implementation Dates

date of Ratification (DOR) (1) 2011-10-01
date of Availability (DAV) (2) 2011-10-14
date of Announcement (DOA) (3) -
date of Publication (DOP) (4) -
date of Withdrawal (DOW) (5) -

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Superseded by  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.