Compliance or non-compliance with EN61000-3-2 will not affect the safety of
the equipment. This is an economic issue, not a safety issue. The EU
restricted harmonics emissions because it is believed that on a
macro-economic level it will be more cost efficient to limit the generation
of power line harmonics than to accommodate them by increasing the size of
the distribution transformers.
----------
From: [email protected] [SMTP:[email protected]]
Sent: Tuesday, June 22, 1999 6:54 AM
To: [email protected]
Cc: [email protected]
Subject: Re: EN 61000-3-2 and medical equipment
To me the Medical Device Directive is not the point...........the
point
is.........will testing to EN 61000-3-2 make your product safer? If
the
answer is "yes" then you should do it. The safety of your customer
or an
innocent user is the ultimate "Directive" that must be passed. It is
usually more important to understand the spirit of the law rather
than the
letter.
===========================================================================
==============
[email protected] (Jon Griver) on 06/21/99 02:48:15 PM
Please respond to [email protected] (Jon Griver)
To: "George, David L" <[email protected]>
[email protected]
cc: (bcc: Robert E. Heller/US-Corporate/3M/US)
Subject: EN 61000-3-2 and medical equipment
David,
>I would like to add one remark about some past messages on this
discussion
>group. EN 61000-3-2 contains limits for "professional" equipment.
This
>category applies to medical equipment and any other products used
in the
>workplace or in manufacturing activities.
>
I would like to clarify this point about EN 61000-3-2 and medical
equipment.
The scope of EN 61000-3-2 may include medical equipment. This is not
the
point. The regulatory requirement in the EU for medical equipment is
the
Medical Devices Directive. The only EMC standard which is harmonized
for
the MDD is EN 60601-1-2, which does not call out EN 61000-3-2.
See
http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/refli
s
t/meddevic.html
So, in order to fulfil the regulatory requirements of the EU,
medical
equipment does NOT have to comply with EN 61000-3-2.
The inclusion of a product group within the scope of an EN standard
does
not necessarily imply that compliance with that standard is
mandatory.
Jon Griver
ITL (Product Testing) Ltd
http://www.itl.co.il
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