Ned,
At a recent AAMI/FDA conference I asked Jeffery Silberberg of the FDA a
similar question and his response was that the new standard would apply upon
the date of recognition by the FDA. As a matter of business, I have been
using the new standard (in Draft form) for the last year or two. I do have
some products that will not meet the new standard but will be re-designed
when a modification is made. For products that are Life Supporting, this
will have a MAJOR impact. Good luck and let me know how it works out for
you.
Regards,
______________________________________________________
Kevin J. Hight - Principal Compliance Engineer
Colorado MEDtech, Inc.
6175 Longbow Drive, Boulder, Colorado 80301
Phone: (303) 530-8288 x-3111 Fax: (303) 581-1003
Email: k...@cmed.com <mailto:k...@cmed.com> http://www.cmed.com
<http://www.cmed.com>
-----Original Message-----
From: Ned Devine [SMTP:ndev...@entela.com]
Sent: Tuesday, February 05, 2002 8:24 AM
To: IEEE EMC/Product Safety (E-mail)
Subject: IEC 60601-1-2 Second Edition
Hi,
I need some help from the EMC experts.
According to FDA Acting Chief of the Brach I am dealing with, since
the FDA
has recognized IEC 60601-1-2 Second Edition (October 2001), then
"...If they
submit a new 510(k) (or even a modification for an existing device)
and we
have recognized the more recent standard, then they would need to
comply
with the new standard." Making the new edition immediately
effective seems
a little harsh. I am appealing his interpretation, but I don't know
if I
will have any luck.
Has anyone had any success in doing a risk analysis to use lower
immunity
compliance levels than specified in IEC 60601-1-2, Second Edition,
Section
36.202.1 a) or using different compliance criteria (36.202.1 j))?
Or does
Clause 6.8.3.201 a) 5), "These justification shall be based only on
physical, technological or physiological limitations..." pretty much
preclude the use of lower limits?
The device in question meets IEC 60601-1-2 First Edition, but will
not pass
the requirements in the Second Edition. Can the "justification" be
that
since there are no known risks on the device, the current level of
immunity
is adequate?
Thanks
Ned
Ned Devine
Program Manager
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI 49548
1 616 248 9671 Phone
1 616 574 9752 Fax
ndev...@entela.com e-mail
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