Try Interpower Components Ltd (www.interpower.com)
transformer product line -
82520010 (100VA);
82520020 (500VA);
82520030 (1000VA);
82520040 (2000VA);
for which they claim UL and CE approval
Ged Dean
From: Bill Johnson [mailto:bi...@kryotech.com]
Sent: 05 March 2003 15:44
To:
I would also disagree with Gregg's statement - the 3 Medical Device
Directives cover a much wider range of products than he suggests, - just
about any device involved in the diagnosis, monitoring, treatment, or
alleviation of desease, injury or handicap. This includes many devices that
the
To my reading the MDD applies only to human patients.
Irrespective of the applicable Directive, you need to consider the
suitabilty of the Standrd you choose to adopt.
In this case 60601 must be more appropriate than 61010 - not least because
safety provisions in the latter make no allowance
With regard to discussion on 'presumption of compliance' conferred by
application of harmonised standards I thought the following passages might
be of interest (taken from 'Safer by Design' by Abbott Tyler, who
according to the sleeve-notes are a product safety management consultant and
a
For general electro-medical equipment see EN-60601-1, clause 15; 'limitaton
of voltage +/or energy'
- specifies restrictions on voltage beteween supply pins, and supply pins
and enclosure, after removal of plug from mains supply (60V after 1sec),
tested under least favourable conditions. (No
Regarding my query on medical equipment transformer construction
(EN-60601-1, clause 57.9.4(e)), can I be a bit more specific.
- How were insulation thickness requirements decided, and why is the
thickness requirement lower if insulation is 2-layer rather than
single-layer ?.
- Why are
With regard to transformer construction, CLAUSE-57.9.4(e) of EN-60601-1
General Requirements for Safety of Medical Electrical Equipment requires:-
In transformers with REINFORCED INSULATION or DOUBLE INSULATION the
insulation between 1ary and 2ary windings shalll consist of -
- 1 insulation
We are users of many types of electro-medical equipment, all of which we
subject to basic safety testing before placing into service in our hospital.
Our experience is that metal-to-metal is the only relaible means of chassis
earth-bonding. We regularly find that equipment delivered to us which
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