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

 

Project

Reference EN 80601-2-58:2009
Title Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Project Number 21530
Abstract/Scope IEC 80601-2-58:2008 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2009-02-06
Current Stage code deadline 2009-11-01
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 80601-2-58:2008 (EQV)
ICS 11.040.70 - Ophthalmic equipment
Keywords Medical;Lens;Surgery;Vitrectomy;Ophthalmic
Note IEC 80601-2-58 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 2009-02-06 2009-11-01 export to doc file  EN  FR  DE
5099 2009-02-01 2009-04-01  
5060 2008-09-29 2008-10-13 export to doc file  EN
5020 2008-07-25 2008-09-26  
3090 2008-06-13 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) 2009-02-01
date of Availability (DAV) (2) 2009-02-06
date of Announcement (DOA) (3) 2009-05-01
date of Publication (DOP) (4) 2009-11-01
date of Withdrawal (DOW) (5) 2012-02-01

Relations

Supersedes  
Superseded by FprEN 80601-2-58:2013
Normative reference (6) ISO 11607-1:2006
ISO 11607-2:2006
ISO 15752:2000
ISO 17664:2004
EN 60601-1-2:2007
corr. March 2010
EN 60601-2-2:2009
A11:2011
EN 60601-2-22:2013
EN 61847:1998

(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.