The wrist support is a medical device and requires a CE mark under
the Medical Devices directive.
Clearly there are no electrical parts in a simple wrist support, but
if there were, there would still be no requirement to comply with the
EMC and LV directives since these are subordinate to the requirements
of the MDD. The MDD contains requirements for EMC and electrical
safety performance, so there is no need to apply the broader
directives.
There are over 20 CE mark directives, covering a wide variety of
products. At the margins, the application of a directive (or
otherwise) is often as much about what the manufacturer claims for a
product as the properties of the product itself. A good illustration
is protective vinyl gloves. If these are sold to surgeons and medics
for use in invasive medical procedures, they are medical devices and
must be CE marked under the MDD. If they are used in a pathology
laboratory to protect technicians when handling specimens, they are
personal protective equipment and must be CE marked under the PPE
Directive. If they are sold to technicians for use in the electronics
industry in order to protect the components being handled, they are
within the scope of none of the CE directives and therefore must not
be marked. The three different requirements are mutually exclusive
and while the product itself may be identical, the marking and
paperwork requirements, and the approval procedures, are all
different.
Quite what lessons we should draw, I'm not sure, except maybe to be
glad you're not a glove manufacturer!
Nick.
At 15:43 -0800 15/12/2000, Gary McInturff wrote:
Nick,
I've seen CE marks on a wrist support for sprained wrists etc. I
haven't a clue what that was all about.
Gary
-----Original Message-----
From: Nick Williams [mailto:[email protected]]
Sent: Thursday, December 14, 2000 3:29 PM
To: Courtland Thomas
Cc: emcpost
Subject: Re: CE Marking Passive devices
Courtland,
Since no one else seems to have answered your basic question, I will
have a go for you.
<SNIP>
-------------------------------------------
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.
To cancel your subscription, send mail to:
[email protected]
with the single line:
unsubscribe emc-pstc
For help, send mail to the list administrators:
Jim Bacher: [email protected]
Michael Garretson: [email protected]
For policy questions, send mail to:
Richard Nute: [email protected]
