Joshua, Looks like they are using pressure tactics instead of
rulemaking.
Unless the pandemic pulls everything back so far that
survival will be the name of the game everywhere for some years you have
some work to do.
Your company needs to pushback. Indirectly thru your 61010
EMC group and directly, if you have been pushed on this by the FDA or lab
claiming FDA, to get this stopped until there is a direct 'order'. Ideally
the FDA should come to the 61010 EMC group and negotiate a change in the EMC
standard which will require the same requirements for some specific
equipment and/or tests which are acceptable - ala 60601 EMC requirements.
It is important to get the requirements in the 61010 EMC family rather than
have you working with 60601 EMC requirements; this will put pressure on the
gov't to justify their requirements technically allowing you to limit the
scope and detail of the additional requirements.
Further, if this is also an Euro CE marking issue (from Euro
medical requirements) then get all the parties into the same room to
renegotiate the EMC requirements in a way that is satisfactory to all
parties (probably will take more time).
It is important to use your industry group to bring max
pressure on doing this in an open and mutually agreeable way - modifying
your standard.
This is not an easy path; there will also be a threat of
Federal rulemaking to move it in the direction they desire.
Get your association legal folks involved early too; they
will advise on strategies to move ahead plus help pushing back on gov't
pressure.
Looks like your spare time for the next 5 years is soaked up
to get this done.
Good luck.
:>) br, Pete
Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe 97321-0413
503/452-1201
IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
<mailto:p.perk...@ieee.org> p.perk...@ieee.org
Entropy ain't what it used to be
From: Wiseman, Joshua <joshua.wise...@orthoclinicaldiagnostics.com>
Sent: Monday, May 4, 2020 12:17 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EMC testing for IVD equipment
FDA has allowed IEC 61326-2-6 for a long time. Word on the street is they
are requiring IEC 60601-1-2 now but there has not been an official
announcement. We heard about it through a trade group.
Story is some manufacturers are being told during their 510(k) reviews and
have required rework very late in the game to meet the more stringent
requirements. Usually, by this time they are about to launch or maybe
already launched in some countries depending on the product and regulations.
Josh
Joshua Wiseman
Systems Engineering
Staff Engineer, Product Safety/EMC
Ortho Clinical Diagnostics
From: rwell...@wellman.com <mailto:rwell...@wellman.com>
<rwell...@wellman.com <mailto:rwell...@wellman.com> >
Sent: Monday, May 4, 2020 2:56 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EMC testing for IVD equipment
EXTERNAL SENDER: Verify links, attachments and sender before taking action
I've been out of doing EMC Compliance for Laboratory Equipment for some
years, but is this a general protocol statement in the IEC standard or an
FDA requirement? I would hope there is an FDA Guidance Document that
clarifies this?
Best regards,
Ron Wellman
From: Ruth Shapira <rshap...@tauex.tau.ac.il
<mailto:rshap...@tauex.tau.ac.il> >
Sent: Monday, May 4, 2020 10:06 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EMC testing for IVD equipment
Hi Josh,
If the IVD equipment is used in a medical environment (hospital, clinic,
etc.) the applied standard is IEC 60601-1-2 ed.4 (in which are specified the
environments for use a medical electrical equipment). If the IVD equipment
is located in a laboratory area out of medical env, the IEC 62368-2-6 (IVD
Lab Equip) standard apply.
I hope that the above help.
Best Regards and lot of health,
Steli
Steli Loznen, M.Sc., SM-IEEE
VP for Technical Activities and Member of BoG IEEE-PSES
Convener IEC 62A/MT29+MT 62354
17-3 Shaul HaMelech Blvd.
Tel Aviv 6436719
Israel
Tel:+972-3-6912668
Fax:+972-3-6913988
Mobile:+972-54-4818816
e-mail: sloz...@ieee.org <mailto:sloz...@ieee.org>
From: Wiseman, Joshua <joshua.wise...@orthoclinicaldiagnostics.com
<mailto:joshua.wise...@orthoclinicaldiagnostics.com> >
Sent: Monday, May 4, 2020 6:05 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] EMC testing for IVD equipment
Recently there has been reports of the FDA requiring in vitro diagnostic
equipment to be tested according to IEC 60601-1-2 (Medical Equip) instead of
IEC 62368-2-6 (IVD Lab Equip).
Does anyone have any information about this?
Thanks,
Josh
Joshua Wiseman
Systems Engineering
Staff Engineer, Product Safety/EMC
Ortho Clinical Diagnostics
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