Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 1-159
Standard
ISO  18778 Second edition 2022-06
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
Scope/Abstract
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:

- intended for use in the home healthcare environment;

- intended for use by a lay operator;

- intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and

- intended for transit-operable use.

NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.

This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.

EXAMPLE probes, cables distributed alarm system
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
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§868.2377 Monitor, Apnea, Home Use Class 2 NPF
Relevant FDA Guidance and/or Supportive Publications*
Apnea monitors - Class II Special Controls Guidance Document for Industry and FDA, issued July 2002.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Rachana Visaria
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5628
  Rachana.Visaria@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.
-
-