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. Author manuscript; available in PMC: 2018 Jan 1.
Published in final edited form as: Anesth Analg. 2017 Jan;124(1):127–135. doi: 10.1213/ANE.0000000000001386

Table 3.

Selected Particular Medical Device Standards and Examples of Basic Information Reported

Medical Device Relevant Particular Standard Examples of Basic Information
Reported or Essential Performance
Requirements
Pulse Oximeter ISO 80601-2-61 Default averaging interval, alarm
settings
Critical Care Ventilator ISO 80601-2-12 Alarm limits for oxygen level,
airway pressure, expired volume
Respiratory Gas Monitor ISO 80602-2-55 Accuracy, alarm settings