CE Mark Technical Construction File for LVD (LED Luminaire)

C

cherrybuere

#1
Hello to everybody

Im Ms.Che of Philippines. I was given a task for CE marking self certification of our new product LED luminaire under LVD directives. I want to ask for a help if you can direct me how to construct technical files - could you send me a format which i can use as guide.

thank you for someone who could help


cherry
 
Elsmar Forum Sponsor

c.mitch

Quite Involved in Discussions
#3
Hello,

Download the guidance issued by the GHTF, on February 21, 2008:
"Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)"

And do exactly what is in part 2 of this guidance.
You may be able to fill 90% of what is required.
For the last 10%, Elsmar Cove waits for your further questions!

Regards,

Mitch.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hello,

Download the guidance issued by the GHTF, on February 21, 2008:
"Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)"

And do exactly what is in part 2 of this guidance.
You may be able to fill 90% of what is required.
For the last 10%, Elsmar Cove waits for your further questions!

Regards,

Mitch.
If this is a medical device or accessory (has a medical purpose) then the LVD doesn't apply:

(LVD)
ANNEX II
Equipment and Phenomena outside the Scope of this Directive
Electrical equipment for use in an explosive atmosphere
Electrical equipment for radiology and medical purposes
...
(emphasis added)

If it's not - the GHTF's guidance doesn't apply.

Ronen.
 
W

w_grunfeld

#5
Ms. Che,
I don't know why did Mitch assume its a medical device, I found nothing in youe qerry indicating it is, so Ronen is right.
Read this guideline wich focuses specifically on LED Luminaires
http://www.celma.org/archives/temp/...coherent_approach_on_LED_lighting_Dec2010.pdf
Among other things it quotes EN 62471 and says other stnadards will be available during 2011 (the paper is from 2010). I remember specifically that a new harmonised Euriopean standard ENXXX? dealing with LED Luminaires was issued. I don't have it's number, try googling "EN Standard for Luminaires ". Basically you should demonstrate that your product conforms with the harmonised standards the 62471+?
You can also search under LVD all the applicable harmonised standards
 
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