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 |