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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 07/06/2020 
FR Recognition Number 1-146
Standard(Included in ASCA pilot)
ISO 80601-2-12 Second edition 2020-02
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Scope/Abstract
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
- intended to be operated by a healthcare professional operator; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 80601-2-12 First edition 2011-04-15 [Rec# 1-98] will be superseded by recognition of ISO 80601-2-12 Second edition 2020-02 [Rec# 1-146]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-98] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 1-98] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.

3. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff, Issued May 2005.

4. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, Issued April 2016.

5. Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff, Issued April 2001.

6. AAMI COVID-19 Emergency Guidance for the design of ventilator, resuscitator, CPAP/BiPAP systems is available at https://www.aami.org/news-resources/covid-19-updates/covid_cr. Check back frequently for the latest version as these are living documents that evolve with experience.
FDA Technical Contacts
 James J. Lee
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-8463
  James.J.Lee@fda.hhs.gov
 Brandon Blakley
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-348-1958
  Brandon.Blakely@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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