• ISO 19223 (Lung ventilators and related equipment- Vocabulary and semantics)

This standard was used to inform the group on the proper terminology in the ventilation space and was used to inform the nomenclature informational section of this document.

• American Heart Association Adult Basic Life Support Guidance

This is not a standard, however it informed specifications of the design including safe ranges of tidal volume and breath cycle length. 

[This standard was used to develop Requirements 3a, 3b, 4a, 4d, 10 and associated specifications.]

• AAMI CR501 (Emergency Use Ventilator Design Guidance)

This design guidance provided specifications for I/E as well as BPM that are required for ventilators for emergency use.

[This guidance was used to develop Requirements 3b, 3c, 4b, 4c, 5, and associated specifications.]

• IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)

This standard was used to develop specifications for the batteries that are planned to be used in our device in order for safe use. 

[This standard was used to develop Requirements 5.2 and 6a and their associated specifications.]

• IEC 62133 (Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications)

This standard is necessary to be implemented in rechargeable battery selection for use in our device in order for safe use. 

[This standard was used to develop Requirement 6b and its associated specification.]

• Federal Specifications for the Star-of-Life Ambulance

This federally regulated specification sheet for standard star-of-life ambulances was used provided specifications for ambulance stowage to inform the size the device must not exceed in order to fit in the ambulance while leaving ample room for other ambulatory devices. 

[This guidance was used to develop Requirement 9.2 and its associated specification/]

• FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff

This FDA guidance informed the decisions of how the device must be able to be sanitized and what sanitization materials could be used.

[This guidance was used to develop Requirement 13.]