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

 

Project

Reference EN 60601-2-36:1997
Title Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
Project Number 5752
Abstract/Scope Applies to the safety of equipment for extracorporeally induced lithotripsy, i.e. device for treatment with extracorporally generated pressure pulses. The applicability of this 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.
Status
Published

Status

Current Stage code 6060
Current Stage code date 1997-05-07
Current Stage code deadline 1997-12-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher BC/CLC/93-01

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-36:1997 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical equipment; Lithotripsy; Extracorporeally induced; Safety
Note EN following parallel vote
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1997-05-07 1997-12-01 export to doc file  EN
5099 1997-03-11 1997-04-11  
5062 1997-01-31 1997-03-11  
5020 1996-10-25 1997-01-15  
1090 1996-10-22 1996-10-25  
1000 1995-12-15    
1000 1993-08-31    

Implementation Dates

date of Ratification (DOR) (1) 1997-03-11
date of Availability (DAV) (2) 1997-05-07
date of Announcement (DOA) (3) 1997-06-01
date of Publication (DOP) (4) 1997-12-01
date of Withdrawal (DOW) (5) 1997-12-01

Relations

Supersedes  
Superseded by FprEN 60601-2-36:2014
Normative reference (6) EN_NO 10002-1:1990
EN 60601-1-2:1993
corr. December 1997
DIN 50 100:1978

(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.