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

 

Project

Reference FprEN 60601-2-34:2011
Title Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Project Number 22292
Abstract/Scope IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2013-05-30
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 62D
Reference Document IEC 60601-2-34:2011 (EQV)
ICS  
Keywords Medical; Invasive; Blood; Pressure; Monitoring
Note Publication editing allocated to svandriessche@cencenelec.eu * Will supersede EN 60601-2-34:2000
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2013-05-30    
5060 2011-04-18 2011-05-09 export to doc file  EN
5091 2011-03-24    
5020 2011-02-11 2011-04-15  
3090 2010-04-16 2010-10-31  
5060 2009-07-27 2009-08-10 export to doc file  EN
5020 2009-02-20 2009-07-24  
1090 2009-02-17 2009-02-20  

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 60601-2-34:2000
Superseded by  
Normative reference (6) ISO 15223-1:2007
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-8:2007
corr. March 2010
EN 60601-2-2:2009
A11:2011
IEC 60601-2-27
IEC 60601-2-49

(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.