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

 

Project

Reference EN 60601-2-57:2011
Title Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Project Number 22374
Abstract/Scope IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2011-04-08
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s) MDD pending (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/TC 76
Reference Document IEC 60601-2-57:2011 (EQV)
ICS 11.040.50 - Radiographic equipment
11.040.60 - Therapy equipment
Keywords Medical,Non-laser light;cometic;Aesthetic;Safety
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2011-04-08   export to doc file  EN  FR  DE
5099 2011-03-07 2011-04-04  
5060 2011-01-17 2011-02-07 export to doc file  EN
5020 2010-11-12 2011-01-14  
3090 2010-05-07 2010-08-31  
5060 2009-09-14 2009-09-28 export to doc file  EN
5020 2009-04-10 2009-09-11  
1090 2009-04-07 2009-04-10  

Implementation Dates

date of Ratification (DOR) (1) 2011-03-07
date of Availability (DAV) (2) 2011-04-08
date of Announcement (DOA) (3) 2011-06-07
date of Publication (DOP) (4) 2011-12-07
date of Withdrawal (DOW) (5) 2014-03-07

Relations

Supersedes  
Superseded by  
Normative reference (6) ISO 3864-2:2004
EN 60947-3:2009
EN 62471:2008

(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.