Hello Anon,
The two standards for IVD instruments are: IEC 61010-1 for electrical safety and IEC 61326 for electromagnetic disturbance (electromagnetic compatibility).
However, if devices you are describing as blood glucose meters, those used for diabetes monitoring, you may also need to consider other standards including IEC 60601-1 standard for medical devices, and other safety standards specific to home use devices, i.e. IEC 60601-1-11. Blood glucose meters are considered IVDs, but also in that realm of medical devices since they are used by laypersons at home. In addition blood pressure monitoring devices are not considered IVDs, but medical devices, so indeed they would need to conform with IEC 60601-1 (safety) and IEC 60601-1-2 (EMD/EMC).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Nov-2020 01:52
From: Leonard Eisner
Subject: Electrical safety and EMC testing standards for IVD's - USFDA
Just because FDA doesn't recognize a standard doesn't mean you can't submit a product using that standard. There are a lot of standards that don't rely on recognized standards. An example for IVD that you may be eluding to isIEC 61010-2-101:2018
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.
Recognized Standards are voluntary and not mandatory for submission to the FDA for any submission type.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
Original Message:
Sent: 16-Nov-2020 01:14
From: Anonymous Member
Subject: Electrical safety and EMC testing standards for IVD's - USFDA
This message was posted by a user wishing to remain anonymous
Hello RA folks,
I was looking at USFDA recognized consensus standards database for safety and EMC standards for IVD devices for example - Blood pressure monitoring systems and blood glucose measuring devices (battery operated).
I was only able to locate IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements) in the FDA Recognised Consensus standards database.
Can anyone provide insight on what standards and versions are accepted by FDA for Electrical safety and EMC testing of such products?
Thanks!