| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
041
|
Date of Entry 04/04/2016
|
|
FR Recognition Number
|
1-106
|
| Standard | |
ISO 17510 First Edition 2015-08-01
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
|
Scope/Abstract| ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It 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). |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Section 5.2 Biocompatibility, Note 1: For parts or materials not intended to be inserted into the nares or mouth (e.g. MASK elbows, tubing, cushions, and faceplates), the gas pathway materials shall be evaluated as skin contact. |
|
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.
Section 5.2 Biocompatibility, Note 1 is in conflict with FDA guidance, see Table A.1 and 'indirect contact' in Attachment G: Glossary, of the guidance cited below, titled Use of International Standard ISO 10993-1. |
|
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. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.
2. Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Issued February 2016.
3. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff, Issued June 2016.
4. 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.
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
|
| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
