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

 

Project

Reference EN 60601-2-39:2008
Title Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Project Number 20657
Abstract/Scope Applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2008-04-24
Current Stage code deadline 2008-12-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-39:2007 (EQV)
ICS 11.040.99 - Other medical equipment
Keywords Medical equipment; Peritoneal dialysis; Dialysis; Safety
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2008-04-24 2008-12-01 export to doc file  EN  FR  DE
5099 2008-03-01 2008-05-01  
5061 2008-01-28 2008-03-01  
5060 2007-08-24 2007-09-11 export to doc file  EN
5020 2006-04-28 2006-09-29  
1090 2006-04-25 2006-04-28  

Implementation Dates

date of Ratification (DOR) (1) 2008-03-01
date of Availability (DAV) (2) 2008-04-24
date of Announcement (DOA) (3) 2008-06-01
date of Publication (DOP) (4) 2008-12-01
date of Withdrawal (DOW) (5) 2011-03-01

Relations

Supersedes EN 60601-2-39:1999
EN 60601-2-39:1999/corrigendum Dec. 1999
Superseded by  
Normative reference (6) EN 60601-1-9:2008
EN 60601-1-10:2008

(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.