| ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 1-72 |
| 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 10651-5:2006 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use.
ISO 10651-5:2006 also specifies the requirements for resuscitator sets.
ISO 10651-5:2006 is not applicable to electrically-powered resuscitators.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5925 | Ventilator, Emergency, Powered (Resuscitator) | Class 2 | BTL |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Issued March 2015. |