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

 

Project

Reference FprEN 60601-2-8:2010
Title Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Project Number 22435
Abstract/Scope IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2011-08-25
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 62C
Reference Document IEC 60601-2-8:2010 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Therapeutic; X-ray; Safety
Note Will supersede EN 60601-2-8:1997 + A1:1997
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2011-08-25    
5061 2010-11-29 2011-02-01  
5060 2010-10-18 2010-11-01 export to doc file  EN
5020 2010-08-13 2010-10-15  
3090 2010-01-08 2010-07-31  
5060 2009-10-14 2009-10-28 export to doc file  EN
5020 2009-05-08 2009-10-09  
1090 2009-05-05 2009-05-08  

Implementation Dates

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

Relations

Supersedes EN 60601-2-8:1997
EN 60601-2-8:1997/A1:1997
Superseded by  
Normative reference (6) IEC 60601-2-1
IEC/TR 60788
EN 61217:2012

(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.