Thanks Pete. Looks like trips to DC again, or maybe Bathesda. I dealt with this
at my last employer for a different issue that one was with the EPA though.
Josh
Joshua Wiseman
Systems Engineering
Staff Engineer, Product Safety/EMC
Ortho Clinical Diagnostics
[cid:image001.png@01D622AA.4C3F4D50]
From: Pete Perkins <peperkin...@cs.com>
Sent: Monday, May 4, 2020 4:52 PM
To: Wiseman, Joshua <joshua.wise...@orthoclinicaldiagnostics.com>;
EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] EMC testing for IVD equipment
EXTERNAL SENDER: Verify links, attachments and sender before taking action
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
p.perk...@ieee.org<mailto:p.perk...@ieee.org>
Entropy ain't what it used to be
From: Wiseman, Joshua
<joshua.wise...@orthoclinicaldiagnostics.com<mailto:joshua.wise...@orthoclinicaldiagnostics.com>>
Sent: Monday, May 4, 2020 12:17 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto: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
[cid:image001.png@01D622AA.4C3F4D50]
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
The information contained in this transmission is intended only for the person
or entity to which it is addressed and may contain confidential, trade secret
and/or privileged material. If you are not the intended recipient(s) of this
message, or the employee or agent responsible for delivery of this message to
the intended recipient(s), do not review, retransmit, disclose, disseminate,
use, or take any action in reliance upon, this information. If you received
this transmission in error, please contact the sender and destroy all printed
copies and delete the material from all computers. In connection with our
business, Ortho Clinical Diagnostics may collect and process your personal
data. For further information regarding how we use this data, please see our
online privacy notice at
https://www.orthoclinicaldiagnostics.com/en-us/home/privacy-policy
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
<emc-p...@ieee.org<mailto:emc-p...@ieee.org>>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Femc-pstc.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007479521&sdata=WhC7lHa0dZD2D1o%2BXanDRB65GaNaD0pcUfTXUgrGXGU%3D&reserved=0>
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fproduct-compliance.oc.ieee.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007489516&sdata=TBTGmMvk9vl067uapgY1SAi2%2FQb9n%2FtN6oOPg4N%2FLhI%3D&reserved=0>
can be used for graphics (in well-used formats), large files, etc.
Website:
http://www.ieee-pses.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007489516&sdata=Y22GOw9pSPuS4RnNlLxnhVsU3Sbn%2Bd1LeAPVNSIlsqM%3D&reserved=0>
Instructions: http://www.ieee-pses.org/list.html (including how to
unsubscribe)<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flist.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007499510&sdata=mBPXpYRkriHPIDRQIbAt06CmVC0HAr2Qgv2SrkuBi7s%3D&reserved=0>
List rules:
http://www.ieee-pses.org/listrules.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flistrules.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007499510&sdata=mHWFGENXlGWxROb%2FmVb%2Bg8IIAzUc%2BtY1zVs2ENWMSe0%3D&reserved=0>
For help, send mail to the list administrators:
Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>>
Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>>
For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>>
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
<emc-p...@ieee.org<mailto:emc-p...@ieee.org>>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Femc-pstc.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007509506&sdata=hzn7Ldfa6pE3dL%2BFEv9MlyJXMJa58zc5kiySLExlxPc%3D&reserved=0>
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fproduct-compliance.oc.ieee.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007509506&sdata=uceX4xV68Owl%2Fiiz9RM3JyHLwkwqS6IpcUYtL8wCeoI%3D&reserved=0>
can be used for graphics (in well-used formats), large files, etc.
Website:
http://www.ieee-pses.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007519499&sdata=A%2Fd%2FSvvOtJ%2F4%2BtwN%2BpyYmyrNAPghNwdCKmkZnSiFDgY%3D&reserved=0>
Instructions: http://www.ieee-pses.org/list.html (including how to
unsubscribe)<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flist.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007519499&sdata=qPIP8QPMItM6hk7PKoI%2FiyI30m363GQ7tc8jWr0y5nY%3D&reserved=0>
List rules:
http://www.ieee-pses.org/listrules.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flistrules.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007529492&sdata=BvpZ1BxR7uT%2FuEsLDc0fuGSoBDvIUp9o70whzTx1xMI%3D&reserved=0>
For help, send mail to the list administrators:
Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>>
Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>>
For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>>
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
<emc-p...@ieee.org<mailto:emc-p...@ieee.org>>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Femc-pstc.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007529492&sdata=afsQ7zTBgKZ4bVrvY%2F6ymciph7RXM%2F%2FKtNoE6mtyYCM%3D&reserved=0>
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fproduct-compliance.oc.ieee.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007539489&sdata=yzzxTqf%2FuIJFawpUX%2FMYdV6NN2Ltx0ji4bZUOg9tnR8%3D&reserved=0>
can be used for graphics (in well-used formats), large files, etc.
Website:
http://www.ieee-pses.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007539489&sdata=%2FfVqBEgg7uXivAAEfMS9NHFwxv9JLNSWpvwPv%2F57qOQ%3D&reserved=0>
Instructions: http://www.ieee-pses.org/list.html (including how to
unsubscribe)<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flist.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007549482&sdata=snh898NjkaGtJ%2BXvR2zf9djwyYCJOVS0o89%2BnYp%2B1Is%3D&reserved=0>
List rules:
http://www.ieee-pses.org/listrules.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flistrules.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007549482&sdata=9S3JKk5%2FvCweTq60eCk45yJLUvbMZ2f7XCQ%2F7VH%2FzSU%3D&reserved=0>
For help, send mail to the list administrators:
Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>>
Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>>
For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>>
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
<emc-p...@ieee.org<mailto:emc-p...@ieee.org>>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Femc-pstc.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007559477&sdata=TdEafcILVxxNSC9QT3hAtE91BvN2DJUS72sdiHhGmog%3D&reserved=0>
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fproduct-compliance.oc.ieee.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007559477&sdata=HP1dhKn5QxTgmj2DQddbgYGV2BR74ux4QiyHAlZHuwI%3D&reserved=0>
can be used for graphics (in well-used formats), large files, etc.
Website:
http://www.ieee-pses.org/<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2F&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007569471&sdata=KuZ%2B8nuAGQSOxCAkqzOp6YT3TUwTIlCOYi84QkbJjHo%3D&reserved=0>
Instructions: http://www.ieee-pses.org/list.html (including how to
unsubscribe)<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flist.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007569471&sdata=meyMP3RsJ61LUC1ES5BXKhqSsJNseCKAQWHJT1cc4xM%3D&reserved=0>
List rules:
http://www.ieee-pses.org/listrules.html<https://nam03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flistrules.html&data=02%7C01%7Cjoshua.wiseman%40ORTHOCLINICALDIAGNOSTICS.COM%7C9f49bd01da174956c0e808d7f06cf0ff%7C6e63ffc0c2fc4cc4b6c4666b2ce89d92%7C0%7C0%7C637242223007569471&sdata=ZOliTv%2BVLzS9z8x0oko%2FoOs%2FNI5u2YqWEDfAlxYtN80%3D&reserved=0>
For help, send mail to the list administrators:
Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>>
Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>>
For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>>
-
----------------------------------------------------------------
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
<emc-p...@ieee.org>
All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html
Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used
formats), large files, etc.
Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html
For help, send mail to the list administrators:
Scott Douglas <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>
For policy questions, send mail to:
Jim Bacher: <j.bac...@ieee.org>
David Heald: <dhe...@gmail.com>
