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

 

Project

Reference FprEN 60601-2-36:2014
Title Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
Project Number 24442
Abstract/Scope IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.
Status
Approval stage

Status

Current Stage code 5060
Current Stage code date 2014-03-17
Current Stage code deadline 2014-04-07
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 60601-2-36:2014 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords  
Note Will supersede EN 60601-2-36:1997
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5060 2014-03-17 2014-04-07 export to doc file  EN
5020 2014-01-10 2014-03-14  
3090 2014-01-07 2014-01-10  
5060 2012-12-17 2013-01-07 export to doc file  EN
5020 2012-09-14 2012-12-14  
1090 2012-09-11 2012-09-14  

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 60601-2-36:1997
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.