Hi Ned,
I think everyone is asking the same question. You have received the correct
interpretation from the FDA. The 2nd edition is effective as of 10-2001 and
if you claim compliance with it on your 510k, the FDA will not come back and
ask for more information regarding EMC. They are however reasonable and do
not expect manufactures to comply on such short notice but they then also
reserve the right to come back and ask you additional questions regarding
the EMC performance of you product which may include why you did not choose
to comply with the 2nd edition of 60601-1-2. Call me if you want more
information regarding this.
You asked: 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))? The
risk analysis that is call for in the 2nd edition is only to determine which
functions of the equipment will be tested for immunity. Only those
functions that are associated with essential performance need be tested.
A risk analysis does not allow essential performance to pass at reduced
levels.
Yes, 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? Your justification for lower immunity
levels must be based on physical, technological or physiological
limitations.
You stated and asked: 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? No you cannot use this as a justification because it is not
based on physical, technological or physiological limitations of your
equipment.
Please contact me directly if you need more help.
Best regards,
Jim
-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Ned Devine
Sent: Tuesday, February 05, 2002 4:24 PM
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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