| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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1-197
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| Standard | |
ISO 17510 Second Edition 2025-11
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories |
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Scope/AbstractThis document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ISO 17510 First Edition 2015-08 [Rec# 1-106] will be superseded by recognition of ISO 17510 Second Edition 2025-11 [Rec# 1-197]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-106] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 1-106] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5905 |
Ventilator, Non-Continuous (Respirator)
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Class 2
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BZD
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015.
2. Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, issued February 2016.
3. Final Guidance for Industry and FDA Staff: Guidance on Medical Device Patient Labeling, issued April 2001.
4. 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.
5. 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 equipment.
6. 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.
7. ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.
8. 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.
9. 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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
