| ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)] |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 1-98 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Bahram Parvinian FDA/OMPT/CDRH/OSEL/DBP/ 301-796-6445 bahram.parvinian@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 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
- intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and
- intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.
ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5895 | Ventilator, Continuous, Facility Use | Class 2 | CBK |
| §868.5895 | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use | Class 2 | MNT |
| §868.5895 | Ventilator, Continuous, Non-Life-Supporting | Class 2 | MNS |
| Draft Reviewer Guidance for Ventilators, July 1995 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, March 2015 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design: June 22, 2011 |