]
From: Pete Perkins
Sent: Monday, May 4, 2020 4:52 PM
To: Wiseman, Joshua ;
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
lto:p.perk...@ieee.org> p.perk...@ieee.org
Entropy ain't what it used to be
From: Wiseman, Joshua
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 stre
James Pawson (U3C)
Sent: 04 May 2020 21:22
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EMC testing for IVD equipment
This is consistent with a customer of mine making a device for stroke patient
rehab in a clinic setting. They've been told that 60601-1-2 is required. Will
ask th
574298
From: Ruth Shapira
Sent: 04 May 2020 18:06
To: 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 t
[cid:image001.png@01D62227.0AB54890]
From: rwell...@wellman.com
Sent: Monday, May 4, 2020 2:56 PM
To: 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 Compl
Sent: Monday, May 4, 2020 10:06 AM
To: 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 me
Fax:+972-3-6913988
Mobile:+972-54-4818816
e-mail: sloz...@ieee.org
From: Wiseman, Joshua
Sent: Monday, May 4, 2020 6:05 PM
To: 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
r
WR Medical Electronics Co
1700 Gervais Avenue | Maplewood, MN 55109 | U.S.A.
Office: 651.604.8473
m...@wrmed.com<mailto:m...@wrmed.com>
From: Wiseman, Joshua
mailto:joshua.wise...@orthoclinicaldiagnostics.com>>
Sent: Monday, May 4, 2020 10:05 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG<mail
: 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?
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, Prod
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