]
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
rg> 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 street is they
are requiring
s 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 them where t
8
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 the
en
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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 Compliance
: 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 medical
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
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<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
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,
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