I.S. EN ISO 17510:2020
Current
The latest, up-to-date edition.
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
Hardcopy , PDF
English
08-03-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information to be supplied by the manufacturer
5 Construction requirements
6 Vibration and noise
Annex A (informative) Particular guidance and rationale
Annex B (normative) Exhaust flow test procedure
Annex C (normative) Resistance to flow (pressure drop)
Annex C (normative) Resistance to flow (pressure drop)
Annex D (normative) Anti-asphyxia valve pressure testing
Annex E (normative) Determination of the inspiratory and expiratory resistance under single fault condition
Annex F (normative) Carbon Dioxide rebreathing
Annex G (normative) Vibration and noise
Annex H (informative) Guide to information to be supplied by the manufacturer
Annex I (informative) Reference to the essential principles
Annex J (informative) Terminology — alphabetized index of defined terms
Bibliography
This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
48
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 17510:2015 | Identical |
| EN ISO 17510:2020 | Identical |
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