Silvia
 
Strictly, the power supply should also comply with EN 61010-1, but I expect
that you will find that there are no practical differences between that and EN
60950-1 for the laboratory environment. I would suggest that whoever assesses
your equipment should also include an assessment of the power supply, which
should amount to no more than a paperwork exercise, the manufacturer of the
power supply having already carried out testing. This will establish the
equivalence of EN60950-1 to EN61010-1 for this application.
 
Best regards
 

Neil Barker

Manager

Central Quality

 

e2v

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________________________________

From: [email protected] [mailto:[email protected]] On Behalf Of Silvia Diaz
Monnier
Sent: 04 February 2009 12:15
To: [email protected]
Subject: In vitro diagnostic equipment with external power supply



Dear all, 

can anyone help me with this doubt? 

A in vitro diagnostic equipment will be tested according to EN 61010-2-101 to
bear CE marking under IVD Directive. It has an external power supply from
another manufacturer that bears a CE Marking under LV Directive, tested by EN
60950-1. The external power supply provides 12 Vdc to the IVD equipment and
will be sold with it. It is allowed to assume the power supply is an approved
critical component or should the power supply be tested together with IVD
equipment?

Thank you. 
Best regards, 
__________________________________________________ 
Eng. Silvia Díaz Monnier 
NATIONAL INSTITUTE OF INDUSTRIAL TECHNOLOGY 
R & D Center of Telecommunications 
Electronics and Computer Science 
  
Te (+54 11) 4724-6369/6390 
Fax (+54 11) 4754-5194/4064 
[email protected] 
___________________________________________________ 
0800 444 4004 | www.inti.gob.ar <file://www.inti.gob.ar>  



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