Table 1.

Summary of requirements on key control and monitoring parameters.

Parameter	Range	Tolerance	Alarmsa	Referenceb
Inspiratory-to-expiratory ratio	1:1-1:4	—c	—	Line 56
Respiratory rate (brpm)	10-30	±2	—	Line 57
Tidal volume (mL)	350-450d (250-600)e	±4%f (± 15%)f	±20%	Line 59
Inspiratory pressure (cmH2Og)	<40	±4%	High, low, continuous	Line 256
FiO2h (%)	External controli	External control	External control	External control

^aAlarm conditions for these parameters are generated in compliance with ISO 80601-2-12 [11], clause 12.

^bAAMI CR503:2020 [10] line number.

^cNot specified.

^dThe required tidal volume range.

^eThe recommended tidal volume range.

^fThe tolerance for tidal volume is reported as bias linearity.

^g1 cmH₂O is equivalent to 98.07 Pa.

^hFiO₂: fraction of inspired oxygen.

ⁱControl of fraction of inspired oxygen is established by connection to an external oxygen supply.