Hi Pierre:
I think the real question is whether the equipment should be compliant with the
Medical Device Directive or the Low Voltage Directive/EMC Directive.
This is the criteria specified in the MDD in Article 1 clause 2a:
" 'medical device' means any instrument, apparatus, appliance, material or
other article, whether used alone or in combination, including the software
necessary for its proper application intended by the manufacturer to be used
for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
- investigation, replacement or modification of the anatomy or of a
physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means; "
It sounds like if your equipment malfunctions, it could affect the treatment of
disease (consider the effects of early termination of haemodialysis ).
Pat Lawler
EMC Engineer
Condor DC Power Supplies
"Pierre Selva" <[email protected]>
Sent by: [email protected]
03/22/2005 02:56 AM
To: "Forum Safety-emc" <[email protected]>
cc:
Subject: Medical or laboratory product ?
Hello all,
One of my customers is making a product which is intended to make measurement
on liquid issued from a haemodialysis system. The product is close to the
haemodialysis system, and it give only information on the liquid quality to
indicate if it’s time to stop the dialyse procedure. It doesn’t have capability
to stop the system,It gives only information to medical personnel. There is no
electrical links between products, only a tubular link with liquid. Product is
not an In Vitro Diagnostic system.
My question is :
What is the most appropriate standard to be use ?60601-1 or 61010-1 ?
Many thanks for your inputs,
Best regards,
Pierre
Pierre SELVA
Responsable certifications produits
EMITECH Rhône Alpes
1 rue des Essarts
38610 GIERES
Ph : +33 (0)4 38 370 007
Fx : +33 (0)4 38 371 004
GSM : +33(0)6 76 63 02 58
[email protected]
www.emitech.fr
