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

 

Project

Reference EN 60601-1-11:2010
Title Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Project Number 22366
Abstract/Scope IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2010-06-04
Current Stage code deadline 2011-03-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-11:2010 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Collateral standard; Healthcare; Home
Note IEC 60601-1-11 developed by ISO/TC 121/SC 3 - IEC/SC 62A WG6 and also circulated in ISO/TC 121/SC 3
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2010-06-04 2011-03-01 export to doc file  EN  FR  DE
5099 2010-06-01 2010-08-01  
5060 2010-04-20 2010-05-04 export to doc file  EN
5020 2010-02-12 2010-04-16  
3090 2009-09-18 2010-02-28  
5060 2009-09-07 2009-09-21 export to doc file  EN
5020 2009-04-03 2009-09-04  
1090 2009-03-31 2009-04-03  

Implementation Dates

date of Ratification (DOR) (1) 2010-06-01
date of Availability (DAV) (2) 2010-06-04
date of Announcement (DOA) (3) 2010-09-01
date of Publication (DOP) (4) 2011-03-01
date of Withdrawal (DOW) (5) 2013-06-01

Relations


(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.