Wesley,
As I understand it, in the WEEE Directive; ANNEX IA, Categories Of
Electrical And Electronic Equipment Covered By This Directive; Medical
devices will have to be compliant to the directive with the exception of
all implanted and infected products.
More food for thought. We had a few Help Line calls coming from the
medical electronics market asking about the effects Lead Free Soldering
would have. The biggest concern was whether or not hardware soldered
with Lead Free solders would have to be re-certified. I contacted the
FDA (05--614 tec RE: DSMICA Email Form Response) on this subject, and
here is their answer:
Re: There are Lead Free solder alloys available for use, primarily Tin
silver Copper (SnAgCu). Using Lead Free solder alloys does not affect
the form, fit, or function of the electronics device. If a medical
electronics equipment manufacturers converts their hardware from SnPb
solders to Lead Free solders, do they have to re-qualify the hardware
prior to releasing the hardware to the consumer?
This is something that each manufacturer must evaluate with respect to
their design control changes and final design verification to determine
if the potential impact does not effect or exceed form fit, or function.
For example, evaluation of the electrical suitability of the composition
of new solder(s)may not be enough.......perhaps the elements and their
ratios within the alloy whether SnAgCu, SnAg, SnSb, or another alloy
must also be evaluated with respect to the working temperature and
hardening characteristics of the alloy as part of the total device
design when taking into consideration such issues as temperature,
vibration, environmental insults, working temperatures and types hand,
drag, wave, etc. of soldering, compatibility and types of fluxes,
ability to remove different fluxes and changes in procedure required to
do so, changes necessary for rework procedures, suitability of the
physical characteristics, eg. tensile strength of the solder if used for
anchoring components, shielding, subassemblies etc, etc.
So the answer is, yes, but the nature and extent of the reevaluation of
the device will depend upon the alloy chosen and its use.
For your information.
Hope this helps.
Lee Whiteman
Senior Manufacturing Engineer
American Competitiveness Institute
E-Mail: [log in to unmask]
Ph: (610) 362-1200 x208
Fax: (610) 362-1290
This message is for informational purposes only and does not supersede,
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-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Malewicz Wesley
Sent: Friday, June 18, 2004 1:25 PM
To: [log in to unmask]
Subject: [TN] Lead Free solder and Medical products
Hi,
Can anyone tell me what is the requirement date for Lead Free Solder
implementation on Medical products is? Is it the same for all products
or
are Medical products still in an exempt category?
Thanking you in advance for your reply.
Wes
Wesley Malewicz
Printed Circuit Development Supervisor
DRAEGER MEDICAL
Draeger Medical Systems, Inc
16 Electronics Avenue
Danvers, MA 01923 USA
Tel: +1 978-907-7776
Fax: +1 978-907-6489
E-mail: [log in to unmask] <mailto:[log in to unmask]>
www.draeger-medical.com <http://www.draeger-medical.com/>
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