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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 1-98
Standard
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)]
Scope/Abstract
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.

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.
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.
FDA Technical Contacts
 Derya Coursey
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  240-402-6130
  Derya.Coursey@fda.hhs.gov
 Brandon Blakley
  FDA/OMPT/CDRH/ODE/DAGRID/RPDB
  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
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