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

 

Project

Reference EN 60601-2-8:1997
Title Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Project Number 8530
Abstract/Scope Specifies particular requirements for the safety of therapeutic X-ray generators operating with nominal X-ray tube voltages from 10 kV to 400 kV inclusive.
Status
Published

Status

Current Stage code 6060
Current Stage code date 1997-09-09
Current Stage code deadline 1998-06-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-8:1987 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical equipment; Therapeutic X-ray; Generator; Safety
Note Former HD 395.2.8 S1
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1997-09-09 1998-06-01 export to doc file  EN
6020 1997-08-01 1997-11-01  
5099 1997-07-01 1997-08-01  
5062 1997-06-06 1997-07-01  
5020 1997-02-28 1997-05-31  
1090 1997-02-25 1997-02-28  

Implementation Dates

date of Ratification (DOR) (1) 1997-07-01
date of Availability (DAV) (2) 1997-09-09
date of Announcement (DOA) (3) 1997-12-01
date of Publication (DOP) (4) 1998-06-01
date of Withdrawal (DOW) (5) dor + 36 months

Relations

Supersedes  
Superseded by FprEN 60601-2-8:2010
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Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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.