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

 

Project

Reference EN 80601-2-30:2010
Title Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Project Number 21531
Abstract/Scope IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2010-09-10
Current Stage code deadline 2011-06-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 80601-2-30:2009 (EQV) + corrigendum Jan. 2010 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical; Safety; Performance; Automated; Sphygmomanometers
Note Supersedes EN 60601-2-30:2000 * IEC 80601-2-30 prepared by a JWG IEC/ISO with IEC lead
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2010-09-10 2011-06-01 export to doc file  EN  FR  DE
5099 2010-09-01 2010-10-07  
5061 2010-06-28 2010-09-01  
5060 2008-12-16 2008-12-30 export to doc file  EN
5020 2008-10-10 2008-12-12  
3090 2008-04-11 2008-06-30  
5060 2008-03-17 2008-03-31 export to doc file  EN
5020 2007-10-12 2008-03-14  
1090 2007-10-09 2007-10-12  

Implementation Dates

date of Ratification (DOR) (1) 2010-09-01
date of Availability (DAV) (2) 2010-09-10
date of Announcement (DOA) (3) 2010-12-01
date of Publication (DOP) (4) 2011-06-01
date of Withdrawal (DOW) (5) 2013-09-01

Relations

Supersedes EN 60601-2-30:2000
Superseded by  
Normative reference (6) ISO 594-1:1986
ISO 594-2:1991
EN 60068-2-27:2009
EN 60068-2-31:2008
EN 60068-2-64:2008
EN 60601-1-2:2007
corr. March 2010
EN 60601-2-2:2009
A11:2011
ISO 81060-2:2009

(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.