| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
1-199
|
| Standard | (Included in ASCA) |
ISO 80601-2-70 Third edition 2025-11
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
|
Scope/AbstractThis document 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.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document 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.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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 7.2.13 and 8.4.1 of the general standard.
... |
|
| Extent of Recognition
|
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 80601-2-70 Second edition 2020-11 [Rec# 1-151] will be superseded by recognition of ISO 80601-2-70 Third edition 2025-11 [Rec# 1-199]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-151] until December 17, 2028. After this transition period, declarations of conformity to [Rec# 1-151] will not be accepted. |
|
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. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015.
3. Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions, issued June 2023.
4. Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, issued February 2016.
5. Final Guidance for Industry and FDA Staff: Guidance on Medical Device Patient Labeling, issued April 2001.
6. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued September 2023.
7. Guidance for Industry and Food and Drug Administration Staff: Electromagnetic Compatibility (EMC) of Medical Devices, issued June 2022.
8. Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, issued August 2013.
9. Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, issued February 2016.
10. ISO 17510 Second Edition 2025-11 Medical Devices - Sleep Apnoea breathing therapy - Masks and application accessories.
11. ISO 10993-3 Third Edition 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
12. ISO/TR 10993-33 First Edition 2015-03 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3.
13. ISO 18562-1 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process.
14. ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.
15. ISO 18562-3 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds.
16. ISO 18562-4 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.021 |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
