Philips Respironics V60, User Manual

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D-6
Regulatory compliance
RF immunity
RFID reader separation distance
The testing specified in this standard applies to medical electrical equipment
and systems used near RFID readers. A medical electrical equipment or
system that is in conformity with this standard is qualified for use as close as
2.5 cm for some RFID applications and 20 cm for others, based on the
maximum amount of radio frequency (RF) output power allowed by the Federal
Communications Commission (FCC) and typical use distances. Medical
electrical equipment and systems that meet less stringent standards, such as
IEC 60601-1-2, could be used safely with RFID readers if the RF output power
of the RFID reader is less than the allowed maximum or it can be assured that
the separation distance between the RFID Reader and the medical electrical
equipment or system will always be much greater than 20 cm.
Guidance on EMC usually includes the parameters of the RF output of the
source (P), the RF immunity of the medical electrical equipment or system,
and the distance between them (d). In general, a medical electrical equipment
or system should operate safely when it experiences field strength (E) that is
equal to or lower than its specified RF immunity. In general, the field strength
falls off proportional to 1/d, although care must be taken because some
environments (where large metallic objects such as HVAC ducts and cabinetry
are present) can cause reflections such that field strength in certain close-in
ranges can be higher further away from the medical electrical equipment or
system that is at closer distances.
Test specifications for RFID immunity
The frequencies specified are not yet part of formal regulatory standard IEC 60601-1-2
4.0ED. They are based on 1) a working draft of IEC60601-1-2 4.1ED:2018 Table 11
Medical electrical equipment – Part 1-2: General requirements for basic safety and essen-
tial performance – Collateral Standard: Electromagnetic disturbances – Requirements and
tests, and 2) AIM Standard 7351731 2.00ED:2016.
RFID specification Test Frequency Test level (RMS)
ISO 14223 134.2 kHz 65 A/m
ISO/IEC 14443-3 (Type A) 13.56 MHz 7.5 A/m
ISO/IEC 14443-4 (Type B) 13.56 MHz 7.5 A/m
ISO/IEC 15693 (ISO 18000-3 Mode 1) 13.56 MHz 5 A/m
ISO 18000-3 Mode 3 13.56 MHz 12 A/m
ISO/IEC 18000-7 433 MHz 3 V/m
ISO/IEC 18000-63 Type C 860-960 MHz 54 V/m
ISO/IEC 18000-4 Mode 1 2.45 GHz 54 V/m