If the medical equipment is not a MEDICAL ELECTRICAL EQUIPMENT as defined in IEC 60601-1, sub-clause 3.63 - noted below than and it is not an active implantable (external device like a controller) or an IVD that are electrically powered (battery, brick power supply or other power supply or line cord connected or similar) then the device wouldn't generate emissions so I EC 60601-1-2 wouldn't apply.
Sub-Clause 3.63
"* MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
NOTE 1 ME EQUIPMENT includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable
the NORMAL USE of the ME EQUIPMENT.
NOTE 2 Not all electrical equipment used in medical practice falls within this definition (e.g. some in vitro
diagnostic equipment).
NOTE 3 The implantable parts of active implantable medical devices can fall within this definition, but they are
excluded from the scope of this standard by appropriate wording in Clause 1.
NOTE 4 This standard uses the term "electrical equipment" to mean ME EQUIPMENT or other electrical equipment.
NOTE 5 See also 4.10.1, 8.2.1 and 16.3."
The asterisk (*) means to see the Annex A for the Guidance and Rationale in the back of the standard for more information. Always a good thing to do.
You should also refer to the recently published FDA Electromagnetic Compatibility (EMC) of Medical Devices: Final Guidance for Industry and Food and Drug Administration Staff – Issued June 6, 2022, replaces draft of November 17, 2020. NOTE transition period: This document will supersede "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices," issued July 11, 2016, 1 year after the publication of this guidance for in vitro diagnostics and 60 days after the publication of this guidance for other device types (e.g. medical devices including home use devices and active implantables) within the scope of this guidance.
------------------------------
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.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 30-Jun-2022 11:56
From: Anonymous Member
Subject: RFID tags and 60601-1-2 compliance
This message was posted by a user wishing to remain anonymous
Hello,
Do RFID tags present in medical devices which are NOT "medical electrical equipment" need to be tested for 60601-1-2 compliance? If not, what is the rationale?
Thank you!