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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 1-115
Standard(Included in ASCA pilot)
ISO 80601-2-70 First Edition 2015-01-15 Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment
ISO 80601-2-70:2015 is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as me equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
It excludes sleep apnoea breathing therapy equipment intended for use with neonates.
ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation.
ISO 80601-2-70:2015 is not applicable to me equipment or an me system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea.
ISO 80601-2-70:2015 is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
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
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. 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
 Amy Levelle
 Sidra Mirza
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.