Leo,
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, compatability 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.
Good Luck.
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,
modify, or create any agreements with ACI. Information contained in this
message does not bind ACI or its affiliates to any commitment, either
express or implied, unless ratified in writing by an authorized
representative.
-----Original Message-----
From: Leadfree [mailto:[log in to unmask]] On Behalf Of Leo Lambert
Sent: Tuesday, June 08, 2004 9:33 AM
To: [log in to unmask]
Subject: [LF]
Good morning, I'm looking for information or directions to get
information
the medical exemption requirements in RoHS.
Medical products as references as an exemption in RoHS. If this is true,
what products fall under that exemption and also what materials fall
under
that exemption?
Under WEEE there is no recycling of implanted or infected products as
these
are exempt. WEEE also recycles medical products.
I need a pointer to what the RoHS exemption are.
Can anyone help.
Thanks,
Leo Lambert
Technical Director
EPTAC Corp.
Longfellow Square, Bldg. II
8025 So. Willow St., Unite 207
Manchester, NH 03103
P. 800-643-7822 ext 15
F. 603-296-2377
[log in to unmask]
www.eptac.com
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