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

 

Project

Reference EN 80601-2-35:2009
Title Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
Project Number 21913
Abstract/Scope IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2009-12-11
Current Stage code deadline 2010-08-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 80601-2-35:2009 (EQV) + corrigendum Mar. 2012 (EQV)
ICS 11.140 - Hospital equipment
Keywords Medical;Blanket;Pad;Mattresses;Heating
Note Future IEC 80601-2-35 prepared by a JWG IEC/ISO with IEC lead * Supersedes EN 60601-2-35:1996
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2009-12-11 2010-08-01 export to doc file  EN  FR  DE
5099 2009-11-01 2010-01-01  
5060 2009-09-22 2009-10-06 export to doc file  EN
5020 2009-07-17 2009-09-18  
3090 2009-03-27 2009-05-31  
5060 2008-11-17 2008-12-01 export to doc file  EN
5020 2008-06-13 2008-11-14  
1090 2008-06-10 2008-06-13  

Implementation Dates

date of Ratification (DOR) (1) 2009-11-01
date of Availability (DAV) (2) 2009-12-11
date of Announcement (DOA) (3) 2010-02-01
date of Publication (DOP) (4) 2010-08-01
date of Withdrawal (DOW) (5) 2012-11-01

Relations

Supersedes EN 60601-2-35:1996
Superseded by  
Normative reference (6) ISO 2439:2008
ISO 3743-1:1994
EN ISO 14971:2012
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-8:2007
corr. March 2010
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.