| ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 1-73 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | James J. Lee FDA/OMPT/CDRH/ODE/DAGID/RPDB/ 301-796-8463 James.J.Lee@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.
ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5915 | Ventilator, Emergency, Manual (Resuscitator) | Class 2 | BTM |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Issued March 2015. |