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.
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
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