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

 

Project

Reference EN 60601-2-43:2000
Title Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
Project Number 5898
Abstract/Scope Establishes safety requirements for the design and manufacture of X-ray equipment for prolonged radioscopically guided interventional procedures. Specifies information which is to be provided with such equipment for the assistance of the user and operator in managing the radiation risk arising from these procedures which could affect patients and staff.
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 2000-12-19
Current Stage code deadline 2001-05-01
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 62B
Reference Document IEC 60601-2-43:2000 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical equipment; X-ray; Interventional procedure; Safety
Note EN following parallel vote * dav postponed to dav+6months * Superseded by EN 60601-2-43:2010
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2000-12-19 2001-05-01 export to doc file  EN
5099 2000-08-01 2000-12-01  
5062 2000-05-25 2000-08-01  
5020 2000-02-11 2000-05-01  
4099 2000-02-07 2000-02-11  
4020 1998-09-25 1999-03-01  
3099 1998-09-21 1998-09-25  
1000 1997-05-23 1998-08-31  
1000 1995-12-15    
1000 1995-09-06 1996-03-06  
1000 1993-08-31    

Implementation Dates

date of Ratification (DOR) (1) 2000-08-01
date of Availability (DAV) (2) 2000-12-19
date of Announcement (DOA) (3) 2000-11-01
date of Publication (DOP) (4) 2001-06-01
date of Withdrawal (DOW) (5) 2003-08-01

Relations

Supersedes  
Superseded by EN 60601-2-43:2010
Normative reference (6) EN 60601-2-7:1998
EN 60601-2-28:1993
EN 60601-2-32:1994
HD 501 S1:1988

(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.